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  • THERAVECTYS Appoints Alain Clergeot Chief Executive Officer
    Paris, December 21th 2015

PARIS--(BUSINESS WIRE)--THERAVECTYS, a French biotech company specialized in lentiviral vector-based therapeutic vaccines and other immunotherapies, is pleased to announce the appointment of Alain Clergeot, MD, as Chief Executive Officer.

Alain Clergeot is physician by training and is graduated from Executive MBA HEC. He practiced Hospital Medicine in France and abroad before joining Schering-Plough Laboratories in 1985.
Two years later he joined Bristol-Myers Squibb as head of clinical research and medical affairs before starting and managing the oncology Business Unit.
He joined Chugai Pharmaceuticals Co. Ltd in 1998 to create the French affiliate, then held Chugai Pharma France’s presidency in 2001 and the responsibility of Head of Operations Europe in 2008.
Alain is Vice-President and co-founder of the Leem Biotech, and member of the board at Paris-Biotech and former member of the Economic, Ethic and Social Board of the Haut Conseil des biotechnologies.

Alain is a seasoned professional in innovation and entrepreneurship and he demonstrated numerous achievements in the pharma and biotech fields over the last twenty five years. As Chief Executive Officer, he will provide his medical, clinical and operational expertise to further develop THERAVECTYS as a leader in immunotherapy against cancers and infectious diseases.

ABOUT THERAVECTYS

THERAVECTYS is a privately-held, fully-integrated discovery & clinical development biotech company, originating from the Institut Pasteur. The company capitalizes on over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property. Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies in oncology and infectious diseases, and has recently achieved a first Phase I/II clinical trial for its vaccine candidate against HIV.

  • THERAVECTYS TO PRESENT DETAILED PHASE I/II RESULTS FROM THE FIRST-EVER LENTIVIRAL-VECTOR BASED THERAPEUTIC VACCINE TRIAL AT THE 2015 TOWARDS AN HIV CURE SYMPOSIUM
    Paris, July 18th 2015

PARIS--(BUSINESS WIRE)-- THERAVECTYS, a Paris-based, fully-integrated discovery & clinical development company specialized in lentiviral vector-based therapeutic vaccines and T-cell therapies announced that detailed results from its phase I/II study will be presented at the 2015 Towards an HIV Cure Symposium in Vancouver, Canada, on 18 & 19 July 2015, immediately preceding the 8th IAS Conference on HIV Pathogenesis, Treatment & Prevention (IAS 2015). 

The randomized, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT02054286) currently enrolled 38 HIV-positive patients under HAART and aimed at comparing the safety, tolerability and immunogenicity of the therapeutic vaccine candidate at 3 different doses (5.106, 5.107 or 5.108 TU) versus placebo. The treatment regimen consisted of two intramuscular injections 8 weeks apart with non-replicative and self-inactivating lentiviral vectors encoding for immunogenic regions of the HIV GAG, POL and NEF proteins. Vaccine-induced HIV-1-antigen-specific T-cell in peripheral blood were characterized by intracellular cytokine staining in all patients, placebo included, before and after HAART interruption 24 weeks after the first injection

We are very pleased to present the clinical data of this first-ever lentivector based therapeutic vaccine trial” says Dr. Hélène TOUSSAINT, senior scientist in charge of the HIV vaccine program.

With the absence of any serious adverse events on all 38 patients and no safety concerns related to the treatment, the clinical data confirmed both safety and tolerance of the lentiviral-based therapeutic vaccine. In addition, the analysis of the immunological data demonstrated the ability of the vaccine candidate to elicit multi-specific and poly-functional CD8 and CD4 T-cell responses in most of the vaccinated patients.

"These data provide further evidence that THERAVECTYS' regimen vaccine is safe and well tolerated, and can induce intense, broad and long-lasting cellular immune responses in vaccinated patients regardless their preexisting immune profile" says Dr. Cécile BAUCHE, Chief Scientific Officer of the Company.

In this trial, a high frequency, from 0.097 to 0.874%, of functional T-cells able to produce at least 2 or 3 cytokines among IFN-γ, TNF-α and IL-2 was evidenced across patients. A dose effect was also observed when comparing the 3 groups, with greater magnitude with the highest dose.

"The clinical data of this trial supports the potential of the lentiviral vector platform developed by THERAVECTYS for the future development of therapeutic vaccines and immunotherapies in oncology and infectious diseases.” says Renaud VAILLANT, Chief Executive Officer, THERAVECTYS.

For a complete review of THERAVECTYS’ technologies & programs, please visit the company’s website.

About THERAVECTYS

THERAVECTYS is a fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute. Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.
Capitalizing over 15 years of fundamental research in the field of lentiviral vectors, the company has built a broad and robust intellectual property position in addition to worldwide and exclusive licenses secured from institutions including Institut Pasteur and Institut Curie.
The company’s lead infectious disease lentivector vaccine has successfully completed a Phase I/II safety & immunogenicity human proof-of-concept study in HIV. THERAVECTYS lead oncology lentivector vaccine will enter clinical trials in 2015 while the company’s CAR T-cell therapies are in the preclinical stage.
Alone or with partners, THERAVECTYS plans to advance its pipeline of oncology and infectious disease therapies using the company’s integrated set of discovery, clinical development, and GMP manufacturing capabilities specialized in lentiviral vector technologies.


  • THERAVECTYS Attends the American Society of Gene & Cell Therapy & Presents a Progress Update on Its R&D and Production Activities
    Paris, May 13th 2015

PARIS--(BUSINESS WIRE)-- May 13th, 2015. THERAVECTYS, the Paris-based, fully-integrated discovery & clinical development company specialized in lentiviral vector-based therapeutic vaccines and T-cell therapies launches a busy 2015 spring/summer congress season by presenting 4 posters at the 18th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) in New Orleans, one of the largest conferences of its kind in the world.

Over the course of the next 3 days, members of the R&D and GMP manufacturing teams will be presenting 4 different posters on the company’s research and development activities related to its differentiated CAR-T cells programs, its lentiviral vectors therapeutic vaccines, as well as the operations of its newly established lentiviral vector bioproduction facility based in Paris.

Please join Dr. Bauche, CSO, with the R&D and production teams while they will be presenting a detailed review and updates during the poster session at the following dates and time:

  • Development of safer & optimized CAR-T Cells using Lentiviral vectors”, Wednesday, May 13 - 5:15-6:45 pm (stand #224)
  • A new cGMP production facility for clinical grade Lentiviral vectors in Europe”, Thursday, May 14 - 5:30-7:00 pm (stand #474)
  • Use of lentiviral vectors to develop anti-cancer immunotherapies”, Thursday, May 14 - 5:30-7:00 pm (stand #425)
  • Development of a successful lyophilization process for clinical grade lentiviral vectors”, Friday, May 15 - 5:30-7:00 pm (stand #671)

Following its presence at the ASGCT, members of THERAVECTYS R&D team can be met at the 21st Annual Meeting of the International Society for Cellular Therapy (ISCT) in Las Vegas prior to their attendance at the 2015 Annual Meeting of the American Society of Clinical Oncology (ASCO) taking place from May 29th to June 2nd in Chicago.

The company will then be present at the BIO International Convention in Philadelphia from June 15-18 where the Business Development team will actively pursue the promising ongoing discussions related to collaborative agreements.

For a complete review of all the scientific & partnering events where members of THERAVECTYS will be present, please visit the company’s web page in Our Science section, in “Congress & Publications”.

About THERAVECTYS

THERAVECTYS is a fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute and a pioneer in the development of lentiviral vector vaccines and CAR T-cell therapies.
The company has optimized and industrialized next-generation methods to exploit the use of lentivectors in new therapies and has built a broad and robust intellectual property position in addition to licenses to fundamental intellectual property from institutions including Institut Pasteur and Institut Curie.
The company’s lead infectious disease lentivector vaccine has successfully completed a Phase I/II safety & immunogenicity human proof-of-concept study in HIV. THERAVECTYS lead oncology lentivector vaccine will enter clinical trials in 2015 while the company’s CAR T-cell therapies are in the preclinical stage.
Alone or with partners, THERAVECTYS plans to advance its pipeline of oncology and infectious disease therapies using the company’s integrated set of discovery, clinical development, and manufacturing capabilities specialized in lentiviral vector technologies. The company is privately-held and based in Villejuif, France.

  • THERAVECTYS Secures Exclusive Access to a VHH fragments Library from Institut Curie and Strengthens Its Proprietary Immunotherapeutic Platform
    Paris, April 14th 2015

PARIS--(BUSINESS WIRE)--THERAVECTYS, a pioneer in the development of lentiviral vector therapeutic vaccines and T-cell therapies, announced today its exclusive license to a library of synthetic humanized camelid VHH fragments, developed at the Institut Curie in Paris, France.

Over the last 10 years, THERAVECTYS has continuously strengthened its in-house expertise in lentiviral vectors and searched to demonstrate synergies with otherinnovative and complementary immunotherapy approaches. These efforts have lead evidence of sustainable remissions in cancer and the durable treatment of major global infectious diseases.

With the addition of the VHH fragments library from the Institut Curie, THERAVECTYS now owns one of the most comprehensive immunotherapeutic platforms able to stimulate and modulate the immune system: prophylactic & therapeutic vaccines (through the direct administration of lentiviral vectors), Chimeric Antigen Receptor (CAR) & T Cell Receptor (TCR) based cell therapies and anti-checkpoint inhibitors, along with additional strategic assets.

Under the terms of the agreement, THERAVECTYS has acquired exclusive worldwide rights to the library to:

  • Generate proprietary receptors for CAR & TCR-based therapies
  • Identify checkpoint inhibitors
  • Screen tumor antigens

In addition to the licensing agreement, THERAVECTYS and the Institut Curie have entered into a long-term R&D alliance, in order to optimize the library and accelerate the development of THERAVECTYS’ ongoing programs in immuno-oncology. The synthetic nature of the library will allow the identification of VHH fragments in less than six months, as well as the engineering of their biochemical properties including affinity and stability.

“Our VHH fragments library offers an unrivalled potential in immuno-oncology. The low molecular weight of VHH fragments allow their insertion into lentiviral vectors and can thus be expressed as CARs on T and NK cells,” said Frank PEREZ, Research Director at the Institut Curie and at the Centre National de la Recherche Scientifique (CNRS).

“We are pleased to collaborate with THERAVECTYS. I am convinced that the intense and long-lasting immune responses induced by their lentiviral vector vaccines, combined with the tumor de-protection effect of our anti-checkpoint VHH fragment, will change the game in the immuno-oncology field and further improve the current immunotherapy-based treatments in cancer,” commented Sebastian AMIGORENA, Director of INSERM Unit 932 at Institut Curie.

About THERAVECTYS

THERAVECTYS is a fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute and a pioneer in the development of lentiviral vector vaccines and CAR T-cell therapies.
The company has optimized and industrialized next-generation methods to exploit the use of lentivectors in new therapies and has built a broad and robust intellectual property position in addition to licenses to fundamental intellectual property from institutions including Institut Pasteur and Institut Curie.
The company’s lead infectious disease lentivector vaccine has successfully completed a Phase I/II safety & immunogenicity human proof-of-concept study in HIV. THERAVECTYS lead oncology lentivector vaccine will enter clinical trials in 2015 while the company’sCAR T-cell therapies are in the preclinical stage.
Alone or with partners, THERAVECTYS plans to advance its pipeline of oncology and infectious disease therapies using the company’s integrated set of discovery, clinical development, and manufacturing capabilities specialized in lentiviral vector technologies.
The company is privately-held and based in Villejuif, France.


  • THERAVECTYS Granted Authorization by the French National Agency for Medicines to Produce Lentiviral Vectors for Clinical Use and CAR-T Cell Therapies under GMP standards
    Paris, March 23th 2015

PARIS--(BUSINESS WIRE)--THERAVECTYS, a clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapies, proudly announces that its manufacturing plant has been granted the status of a GMP pharmaceutical manufacturing establishment, by the French National Agency for Medicines and Health Products Safety (ANSM). The new facility will be used to produce lentiviral vectors for clinical development purposes, from phase I through phase III, and will also be used to manipulate human cells in the context of Chimeric Antigen Receptors (CARs) and T-Cell Receptor (TCR)-based cell therapies.

Following the completion by THERAVECTYS of the first vaccination trial ever performed in humans with lentiviral vectors, this newly granted authorization further strengthened THERAVECTYS’ leadership in the immunotherapy field. Over the last 10 years, the company has established a unique expertise in lentiviral vector-based therapy. This breakthrough technology is further supported by THERAVECTYS innovative and complementary R&D activities including the development and the use of a synthetic humanized nanobody library and a proprietary and differentiated CAR T-cell technology.

“Obtaining the status of a pharmaceutical manufacturing establishment is a major achievement for THERAVECTYS. We are proud of the team’s dedication to this project, which has allowed us to carry out the work and obtain the opening approval in only 12 months,” said Chief Operating Officer, Amel Hadri.

The new facility will be used to fulfill the company’s internal clinical development program needs, in addition to those of strategic pharmaceutical partners. In the coming months, THERAVECTYS will produce cGMP lentiviral vectors for its first phase I/II clinical trial in oncology (adult T leukemia/lymphoma induced by HTLV-1) and for its differentiated CART-cell-based immunotherapy upcoming clinical trial.

Besides the control of its manufacturing costs and timelines, the self-operation of its manufacturing and quality control processes will allow the company to best leverage and mutualize a common production process for both research and clinical development material requirements as well as protect its unique proprietary know-how and trade secrets.

The production site is designed in compliance with GMP and ISO standards and consists in several independent production suites, including upstream and downstream process rooms, an aseptic filling suite, and a logistic zone that allows for GMP storage at various temperatures ranging from -80⁰C to 25⁰C. Additionally, the installation includes a quality control laboratory.

The plant has a full annual capacity of 24 active batches. Human cells will be cultured in suspension in up to 1,000 liter bioreactors, using synthetic medium and disposable materials. THERAVECTYS proprietary specific quality controls have been developed, such as RCL (replication-competent lentivirus – the validation of the non-replicative nature of the vector), lentiviral vector titration, and residual DNA characterization. These controls have been fully internalized for better product qualification and more efficient batch releases.

THERAVECTYS has continued to improve its industrial processes to strengthen its trade secrets and Intellectual Property (IP). Major accomplishments include the development of a stable cell line to increase production yield, the implementation of an improved lyophilization process leading towards a more stable final product, as well as the design and the validation of new, specific and proprietary quality controls. These achievements, and the company’s unique and unrivaled expertise, offer a significant competitive advantage in the field of immunotherapy.

“With the opening of our GMP manufacturing plant, based on the exclusive worldwide IP license from the Institut Pasteur, THERAVECTYS is the only company in the world to offer a fully-integrated and protected cutting-edge lentiviral vector technology platform,” said Chief Executive Officer of THERAVECTYS, Renaud Vaillant.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.
The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.
Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.
The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.
Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

  • Delaware Court finds that THERAVECTYS is reasonably likely to succeed on the merits of its tortious interference claim against Immune Design Corp.
    Paris, March 10th 2015

Claims are in relation to THERAVECTYS’s novel lentiviral vectors used in development of vaccines and immunotherapy for cancers and infectious diseases

PARIS--(BUSINESS WIRE)--THERAVECTYS announced today a ruling by the Delaware Court of Chancery on the motion for preliminary injunction filed by THERAVECTYS against Immune Design Corp. (“IDC”) in a lawsuit filed in July 2014.  THERAVECTYS alleges in its lawsuit that IDC tortiously interfered with its contractual rights by inducing Henogen SA (“Henogen”) to manufacture lentiviral vectors for IDC in breach of Henogen’s exclusive manufacturing obligations to THERAVECTYS, and that IDC also misappropriated THERAVECTYS’ trade secrets, among additional issues.

In its ruling, the Delaware Court held that THERAVECTYS is reasonably likely to succeed on the merits of its tortious interference claim, and also that “the record may later support a finding that [IDC’s conduct] constitutes trade secret misappropriation.”  Although the Court declined to enter an injunction at this time, it expressly recognized that THERAVECTYS “may have claims for past damage” against IDC, and that “a final remedy tailored to address [IDC’s] conduct may [ultimately] be warranted.”  The Court determined that, at this preliminary stage of the litigation, questions remain concerning the precise nature and degree of the additional harm THERAVECTYS would suffer prior to the trial, which is expected to be held later in 2015.

“We are very pleased and encouraged that the Court recognizes our likelihood of success in establishing IDC’s tortious interference with our contractual rights.  We are optimistic about the outcome of our case at trial,” said THERAVECTYS CEO, Renaud VAILLANT.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.

The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.

Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.

The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.

Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.


  • THERAVECTYS obtains Orphan Drug designation from the European Medecines Agency for its lentiviral vector-based therapeutic vaccine against Adult T-cell Leukemia and Lymphoma
    Paris, February 4th 2015

PARIS--(BUSINESS WIRE)--

“On World Cancer Day 2015, we are proud to be one of the most innovative players in the immuno-oncology space, developing a new kind of treatment for more sustainable remission. In our continued effort to improve patient care, we are moving to the next stage in our fight against cancer with the launch of our clinical trial for virally-induced Adult Leukemia/Lymphoma.” Says Renaud Vaillant, CEO

THERAVECTYS, a fully-integrated discovery and clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapy, announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to its therapeutic vaccine candidate for the treatment of Adult T-cell Leukemia/Lymphoma (ATL/L).

ATL/L is a rare malignancy of a certain type of white cells, T-Lymphocytes, caused by the Human T-Cell Lymphotropic Virus type 1 (HTLV-1) with a prevalence up to 1% of the overall population in Japan. Approximately 5% of all patients infected with HTLV-1 will develop ATL/L, in their lifetime.

Four ATL/L subtypes have been described, with a poor prognosis (less than a year for the two most aggressive forms). Patients are confronted with a lack of well-tolerated and/or performant treatment options which, to-date, include biological treatments with serious adverse reactions as well as aggressive chemo and antiviral therapies or, when eligible, long and uncertain hematopoietic stem cell transplantation.

The biological compound is an investigational therapeutic vaccine aiming at inducing an immune response against HTLV antigens born by ATL/L with the aim of enabling the patients’ immune system to fight leukemic cells.

“Preclinical immunogenicity results obtained to-date are very promising and we are really excited by the perspective bringing a safe and better-tolerated alternative to patients who are desperately in need of a treatment” says Déborah REVAUD, Senior Scientist in charge of the development project.

In Europe, the Orphan designation is granted to drugs in development intended for the treatment, the prevention or the diagnosis of life-threatening or chronically-debilitating diseases of a prevalence lesser than 5 in 10,000 people. The designation allows sponsors to benefit from an accelerated development process as well as incentives and a 7 years market exclusivity once the drug is placed on the market.

“We are extremely pleased that the European Medicines Agency has granted an Orphan Drug status to our vaccine candidate against ATL/L” says Emmanuelle Sabbah-Petrover, Head of Regulatory Affairs. “This is a significant milestone for THERAVECTYS and we intend to take full advantage of all incentives associated with this designation to pursue and further accelerate the development of the compound. We expect to recruit our first patients towards the end of Q3 2015 in Europe and advance further developments in the U.S. and in Japan in 2016”.

Should the vaccine candidate demonstrate a convincing safety and efficacy profile during its development against ATL/L, the company is already considering the perspective of further developing the same vaccine candidate for HTLV-related infections as a therapy and possibly as a prophylactic approach.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.
The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.
Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.
The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.
Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

  • THERAVECTYS Secures €1.9 Million from Bpifrance
    Paris, January 26th 2015

PARIS--(BUSINESS WIRE)--THERAVECTYS, a French biotech company specialized in the development of a new generation of therapeutic vaccines and immunotherapies against major global infectious diseases and cancers, announced the grant of €1.9 million from Bpifrance in the form of a repayable advance as part of the Development of Innovation Assistance program (ADI).

With this support, Bpifrance contributes to the funding of the optimization and the upscale of the production process of lentiviral vectors as well as the conduct of regulatory preclinical studies of a therapeutic vaccine against Adult T-Cell Leukemia/Lymphoma virally-induced by HTLV-1.

“We are delighted to benefit from the renewed confidence of Bpifrance. With this support, THERAVECTYS will be able to accelerate the optimization of its manufacturing process and the production of lentiviral vectors and T-cell therapies to be used in clinical trials. The valuable combination of our expertise and manufacturing capabilities will further strengthen THERAVECTYS’ position as a recognized leader in the space of lentiviral vectors”, said Renaud VAILLANT, Chief Executive Officer.

Pascale PIEL, the company’s Chief Financial Officer commented on the quality of the exchanges between Bpifrance and THERAVECTYS. “Through the support of our manufacturing activities, this €1.9 million contribution will put us in a better position to successfully conduct the preclinical and Phase I/II trials related to our first vaccine candidate in oncology and against an indication of particular interest for Japan”.

Sophie MAGNÉ, Regional Deputy Director of Bpifrance for the Greater-Paris emphasizes, “Bpifrance is a public institution with no equivalent in Europe. Our mission is to help fulfill a national priority: contributing to making France a great place for innovation and of entrepreneurs. Biotechnology is one of our top three priority, along with Digital and CleanTech. We are proud to take part in the development of THERAVECTYS, one of the most promising innovative biotech company, using a unique and novel vaccination approach.”

Collaboration between Bpifrance and THERAVECTYS

The long-established and trustful relationship between Bpifrance and THERAVECTYS has recently led the bank to reward the company for its growth and innovation potential and welcome Renaud VAILLANT its CEO to join Bpifrance’s Excellence Network.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.
The company capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.
Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.
The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.
Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

About Bpifrance

Formed by the law of 31 December 2012, Bpifrance (a public sector investment bank) is the outcome of the merger between OSEO, the FSI, CDC Entreprises and FSI Régions. Its two shareholders are the French state and the Caisse des Dépôts bank. Its object is to support businesses (SMEs, medium-sized enterprises and larger companies of a strategic importance to the French economy), from start-up through to stock market flotation, by providing loans, guarantees and equity. Bpifrance also provides enhanced support and backing for innovation, export, and external growth. With its 42 regional offices, it is a one-stop shop for entrepreneurs in each region for all their finance and investment needs.


  • THERAVECTYS launches its new website & wins Deloitte’s Technology Fast50 «2014 Biotech d’Avenir» Award
    Paris, December 15th 2014

A rewarding November for the promising French biotech: a prestigious prize & an impactful communication tool

PARIS, Dec 15, 2014 - THERAVECTYS wins Deloitte Technology Fast 50 “2014 Biotech d’Avenir”, a prize awarded to one of the fastest-growing, most innovative & dynamic biotech company of the year. In addition, THERAVECTYS is proud to announce the launch of its responsive and easy-to-navigate website www.theravectys.com featuring new sections & content.

A special prize granted by Deloitte Technology Fast 50

Over the last 13 years, this annual event has gathered French leading actors to recognize the fastest-growing companies and the most successful fundraisers of the year.

For the first time since its creation, Deloitte Technology Fast 50 showcased Biotech & Medtech and granted THERAVECTYS with the “Biotech d’Avenir” award in recognition of its continuous efforts to develop innovative therapeutic vaccines and immunotherapies in cancer and infectious diseases.

“We are convinced that all rewarded companies are spear-heading tomorrow’s economic activity and are the catalysts of a dynamic growth leading to jobs and value," said Ariane Bucaille and Vincent Gros, both Partners of Deloitte Technology Fast 50.

 

A new, trendy & highly-functional website 

THERAVECTYS enjoys an entirely new website inspired by the company’s logo and graphic chart featuring current design trends. With its light-colored background, large pictures for a maximum graph-effect and animated colored icons, the website offers a pleasant and easy way to navigate.

Seven sections are reachable from the header menu and are supplemented by linked information reachable through the footer, including links to the main social networks. The highly-functional design allows an easy access to company’s Vision and Mission as well as a detailed review of its technology platform, ongoing programs and agenda.

Discover THERAVECTYS cutting-edge technology in “Our Science” and navigate through the many sections such as “Technology” where you will learn everything about lentiviral vectors and their mode of action, “Manufacturing” will take you through the process development of new vaccine candidates for clinical trials. Other Chapters such as “Our Pipeline” and “Clinical Trials” will provide you with a detailed overview of the company’s R&D activities and pipeline across a variety of indications as well as regular updates on ongoing clinical trials.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.

THERAVECTYS capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.

Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.

The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.

Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

 

About DELOITTE

Deloitte” is the brand under which tens of thousands of dedicated professionals in independent firms throughout the world collaborate to provide auditconsultingfinancial advisoryrisk managementtax and related services to select clients. These firms are members of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”). Each DTTL member firm provides services in particular geographic areas and is subject to the laws and professional regulations of the particular country or countries in which it operates. Each DTTL member firm is structured in accordance with national laws, regulations, customary practice, and other factors, and may secure the provision of professional services in its territory through subsidiaries, affiliates, and other related entities. Not every DTTL member firm provides all services, and certain services may not be available to attest clients under the rules and regulations of public accounting. DTTL and each DTTL member firm are legally separate and independent entities, which cannot obligate each other. DTTL and each DTTL member firm are liable only for their own acts and omissions, and not those of each other. DTTL does not provide services to clients.

  • THERAVECTYS Further Strengthens the Intellectual Property of Its Lentiviral Vector Technology
    Paris, December 3th 2014

THERAVECTYS announces the grant of a European Patent protecting
“Lentiviral Vectors containing a MHC Class I Promoter”

PARIS, Dec 3, 2014 ( BUSINESS WIRE) - THERAVECTYS, a fully-integrated discovery and clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapies, announces the grant of its European Patent “Lentiviral Vectors Containing an MHC Class I Promoter” only two years after its initial filing (website).

The patent describes and claims lentiviral vectors using MHC class I gene promoters, “methods of making the vectors and methods of using them, including medicinal uses”.

Within the lentiviral vectors, the role of the promoter is to control the in vivo expression of the vectorized antigens. MHC class I promoters are naturally highly active in Antigen Presenting Cells thus inducing a broad, intense and long-lasting CD4+/CD8+ immune response following the injection of THERAVECTYS vaccines. The resulting stimulation of the cellular immune response leads to the elimination of the targeted infected or carcinogenic cells as well as all cells transduced by the vector post-injection. The use of this family of promoters contributes to further enhance the efficacy and safety of THERAVECTYS lentiviral vector platform.

THERAVECTYS owns over 20 patent families, either developed in-house or exclusively licensed from the Pasteur Institute from which the company has secured exclusive worldwide rights for the use of lentiviral vectors in vaccination and immunotherapy applications.

THERAVECTYS has implemented a systematic approach to strengthen its intellectual property by protecting:

  • Any new indication-specific vaccines and immunotherapeutic candidates (including those derived from the company’s proprietary Chimeric Antigen Receptors technology);
  • All improvements brought to the lentiviral vector platform and the bioproduction process.

“I am extremely pleased with the grant of this important European patent protecting our MHC Class I promoters. It confirms that THERAVECTYS is at the forefront of lentiviral vectors optimization including packaging, delivery, expression, and immune response” says Dr. Cécile BAUCHE, CSO. “This achievement clearly demonstrates our ability to build one of the broadest and most valuable lentiviral vectors patent portfolios in the world”.

“The protection and the defense of our innovation is at the heart of our overall strategy” says Renaud Vaillant, CEO. “This important milestone not only demonstrates our ability to stay ahead of the game but more importantly creates a key competitive advantage which we intend to transform into long-term value for ourselves, our partners and our investors”.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.

THERAVECTYS capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.

Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.

The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.

Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.


  • THERAVECTYS Provides Update on Its Phase I/II Lentiviral Vector-Based Therapeutic Vaccine Trial
    Paris, November 18th 2014

THERAVECTYS Provides Update on Its Phase I/II
Lentiviral Vector-Based Therapeutic Vaccine Trial

PARIS, Nov 18, 2014 (BUSINESS WIRE) - THERAVECTYS a fully-integrated discovery and clinical development biotechnology company focusing on the development of therapeutic vaccines and immunotherapies, reports promising preliminary results in the first-ever vaccination trial conducted with lentiviral vectors.

The randomized, placebo-controlled trial currently enrolls 38 HIV-positive patients under highly active antiretroviral therapy (HAART) in 12 clinical sites in France and Belgium and aims at comparing the safety, tolerability and immunogenicity of its therapeutic vaccine candidate at 3 different doses (5.106, 5.107 or 5.108 TU) versus placebo.

The treatment regimen consists of two intramuscular injections with non-replicative and self-inactivating lentiviral vectors encoding for disease-specific antigens under the regulation of THERAVECTYS patent-protected human promoter (ß2-microglobulin).

With the absence of any serious adverse events on all 38 patients and no safety concerns related to the product, the interim results confirm the remarkable safety profile of THERAVECTYS lentiviral vector technology platform.

In addition, the interim analysis of the immunological data from the first two cohorts of patients performed by THERAVECTYS demonstrates the ability of the vaccine candidate to elicit multi-specific and poly-functional CD4+ and CD8+ cellular immune responses in vaccinated patients. The immune response elicited by the vaccine was observed even at the lowest dose.

Upon completion of the study in December 2014, detailed results will be presented in peer-reviewed communications at international congresses and in scientific publications.

The interim analysis of this trial supports the potential of the lentiviral vector platform developed by THERAVECTYS for the future development of therapeutic vaccines and immunotherapies in oncology and infectious diseases.

Within the next few months, THERAVECTYS expects to initiate a phase I/II clinical trial with its immunotherapy candidate against HTLV-1-induced adult T-cell leukemia/lymphoma and to initiate a dialogue with regulatory agencies on the clinical development of its proprietary CAR T-cells.

About THERAVECTYS

THERAVECTYS is privately-owned, fully-integrated discovery and clinical development biotech company originating from the Pasteur Institute.

THERAVECTYS capitalizes over 15 years of fundamental research in the field of lentiviral vectors and has secured worldwide exclusive rights to Pasteur Institute intellectual property.

Based on its lentiviral vector technology platform, THERAVECTYS develops therapeutic vaccines and immunotherapies to fight cancers and infectious diseases, including a proprietary and differentiated CAR T-cell technology platform.

The company is strongly supported by renowned investors and former global biopharmaceutical executives and is rapidly progressing in its R&D activities and in-house GMP production capabilities.

Alone and in collaboration with partners, THERAVECTYS is accelerating its clinical development programs and is planning to initiate two additional phase I/II clinical trials in oncology in 2015.

  • THERAVECTYS Files Suit in the U.S. Against Immune Design Corp.
    Paris, July 25th 2014

Lawsuit raises claims of tortious interference with contractual relations,
misappropriation of trade secrets, unfair competition and unjust enrichment

PARIS, Jul 25, 2014 (BUSINESS WIRE) - THERAVECTYS announced that it filed a lawsuit against Seattle-based Immune Design Corp. (“IDC”) in the Delaware Court of Chancery and is seeking preliminary and permanent injunctive relief, as well as monetary damages. In its suit, THERAVECTYS raises claims of tortious interference with contractual relations, misappropriation of trade secrets, unfair competition and unjust enrichment.

The lawsuit alleges that IDC induced THERAVECTYS’ exclusive manufacturer, Henogen SA (“Henogen”), to breach its exclusivity obligations by manufacturing and supplying cGMP clinical batches of lentiviral vectors for IDC. As a result, the lawsuit claims that IDC misappropriated THERAVECTYS’ trade secrets, tortiously interfered with THERAVECTYS’ contractual relationship, has been unjustly enriched and is knowingly using lentiviral vectors unlawfully manufactured for IDC by Henogen. This lawsuit follows an April 11, 2014 judgment in the Paris Commercial Court in THERAVECTYS’ favor. In that judgment, the Paris Commercial Court found, among other things, that Henogen had breached its contractual obligations to THERAVECTYS by making lentiviral vectors for IDC.

The lawsuit seeks monetary damages, as well as injunctive relief preventing IDC from (1) directly or indirectly using lentiviral vector vaccines developed or produced by Henogen; and (2) citing to the U.S. Food and Drug Administration or otherwise relying upon any clinical trials using lentiviral vector vaccines developed or produced by Henogen.

About THERAVECTYS

THERAVECTYS is a French biotechnology company engaged in the development of a new generation of vaccines based on the lentiviral vector technology, a breakthrough technology originating from fundamental research at Pasteur Institute. It is expected to enable the prevention or the treatment of cancers and major global infectious diseases where the induction of a strong and effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers, etc. By way of a worldwide exclusive agreement with the Pasteur Institute and the financial support from public authorities (Bpifrance, i.e. the former OSEO, and ANR), THERAVECTYS continues to invest in research and development to fight against major pathologies. Alone or in collaboration with other partners, THERAVECTYS plans to shortly begin the clinical development of further vaccine candidates. Since its creation, THERAVECTYS has been pursuing the development of a therapeutic anti-HIV vaccine and a phase I/II clinical trial is currently underway.


  • THERAVECTYS finalizes the recruitment of patients for the phase I/II clinical trial of its anti-HIV therapeutic vaccine candidate
    Paris, February 5th 2014

World-first use of lentiviral vector technology in the field of vaccines

THERAVECTYS, a French biotechnology company specializing in the development of vaccines based on lentiviral vector technology, announced today the finalization of recruitment of patients for the first anti-HIV therapeutic vaccination trial, currently in progress in France and Belgium.
This study of the first administration to humans aims to study the safety, tolerance and immunogenicity of its vaccine candidate in patients infected with HIV, undergoing highly active antiretroviral therapy (HAART).
36 patients were included in the study. Preliminary results will be available from June 2014 onwards and definitive results over the next 12 months.
Odile Launay, the clinical trial coordinator, indicated: “I would like to offer my most sincere thanks to all of the centres taking part in this world-wide premiere of a vaccine trial using lentiviral vectors. The search for a vaccine-based solution for patients infected with HIV remains a priority and the ongoing trial will contribute to the achievement of this objective.”
Paul GINESTE, Director of Clinical Development, indicated: “With the aid of the centres taking part in this trial, THERAVECTYS has just reached an important stage. It allows us to plan the analysis of the results that will certainly lead THERAVECTYS to pursue the development of its candidate vaccine for a registration of this indication”.
The United Nations estimates that around 34 million individuals are infected with HIV throughout the world. Sub-Saharan Africa is by far the part of the world where the impact is highest, representing 69% of global cases. Within Europe and on the American continent, the number of infected individuals is estimated to be 2.3 million and 3 million respectively. Associations of antiretroviral treatments have enabled to delay the AIDS phase. These treatments must nevertheless be continued for life, in order to keep the infection in a quiescent state for as long as possible. The stimulation by a vaccine of the immune system of infected individuals could either permit patients to stop the antiretroviral treatment, or significantly reduce the number and doses of these antiretroviral treatments, while maintaining control of the infection.

The vaccine candidate

The therapeutic anti-HIV vaccine, the first candidate to emerge from THERAVECTYS’ research, uses its proprietary lentiviral vector technology for vaccine use. Unlike other gene transfer vectors, lentiviral vectors are capable of inducing a cellular and humoral immune response, which is simultaneously strong, durable and diversified. This induced immune response is specific to HIV and to cells infected by the virus. It participates in the control of this infection by the immune system.

About THERAVECTYS

THERAVECTYS is a French biotechnology company that is developing a new generation of vaccines based on lentiviral vector technology. This breakthrough technology came from fundamental research at Institut Pasteur. It is expected to enable the prevention or effective treatment of many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers, etc. Since its creation, THERAVECTYS has been working to develop a therapeutic anti-HIV vaccine whose phase I/II clinical trial is currently under way.
Benefiting from an exclusive world licence agreement with Institut Pasteur and financial support from public authorities (Bpifrance, i.e. the former OSEO, and ANR), THERAVECTYS is continuing to
invest in research and development to fight against other pathologies. Alone or in collaboration with other pharmaceutical players, THERAVECTYS plans shortly to begin developing new candidate vaccines.

  • THERAVECTYS appoints a Head of Clinical Development and a Head of Strategy and Business Development to strengthen its Executive Committee
    Paris, November 27th 2013

Both appointments clearly reinforce THERAVECTYS' intention to accelerate its strategic development

THERAVECTYS is a French biotechnology company specializing in the development of vaccines based on lentiviral vector technology. Today the company announced the appointments of Paul GINESTE as Head of Clinical Development and Pierre D'EPENOUX as Head of Strategy and Business Development.

Paul GINESTE, age 43, formerly Director of Clinical Studies at AB Science, will head up clinical development at THERAVECTYS to bring in-house vaccine candidates into the clinics.

Pierre d'EPENOUX, age 46, formerly VP of Strategy and Business Development Europe at Sanofi, will be responsible for THERAVECTYS' strategic planning as well as establishing alliances with leading research institutes and global strategic partners.

Renaud VAILLANT, CEO of THERAVECTYS, adds, "In October 2013, we announced that the company raised €14.7 million to accelerate the development of its vaccine platform and establish international collaborations. Today, we are pleased to confirm the appointments of these two experts and to welcome them at the Executive Committee. With these recruitments, the company will further speed-up its in-house clinical development and business development activities, especially internationally."

Bringing advanced vaccine candidates through the clinics up to the market

Paul GINESTE began his career in 1998 with Boehringer Ingelheim as International Clinical Trials Manager before taking over, in 2003, the position of Head of Clinical R&D at Altana. In 2007, Paul was appointed Director of Clinical Studies at AB Science where he led the clinical development in the U.S. and Europe of the tyrosine kinase inhibitor for the treatment of various cancers and autoimmune diseases. Paul holds a doctorate in pharmacy from the University of Rouen, France and also holds a Master’s degree in European medical law from the University of Paris 11. "I am really delighted to bring to THERAVECTYS my 18 years of experience in clinical development, from the very early phase up to the latest stages. THERAVECTYS' lentiviral vector technology is likely to provide major therapeutic advances in a great number of diseases. A phase I/II clinical trial for a therapeutic HIV vaccination is currently underway. It is now a question of demonstrating the potential of our technology in patients suffering from other infectious diseases and cancers. For the years to come, this is actually one of our main challenges".

Alliances with strategic partners & leading research institutions

Pierre d’EPENOUX brings 20 years of experience in strategy and corporate development with leading international pharmaceutical companies. In 1995, Pierre founded the affiliate of Merck/Lipha in Vietnam-Laos-Cambodia. Four years later, he joined the headquarters of Merck KGaA in Darmstadt as director of Mergers & Acquisitions where he participated in the efforts to strengthen the presence of the company in the biotechnology field and in the pharmaceutical field in Japan through the acquisition of a local player. In 2002, Baxter Healthcare appointed him as Senior Director of Business Development where he led most of the restructuring of the renal business. In 2009, Pierre joined Sanofi in Paris as Head of Strategy & Business Development Europe, a position he held for four years before joining THERAVECTYS. Pierre is a graduate of the Advancia business school in Paris and Drexel University in Philadelphia. "THERAVECTYS is an ambitious biopharmaceutical company able to work right alongside the global players in the biotechnology arena and the pharmaceutical industry in general. I am convinced by the innovative vaccine approach the company has developed, as well as the quality of the team. I am pleased to bring THERAVECTYS my experience in structuring and negotiating deals as well as the planning of the strategic deployment of organizations."

About THERAVECTYS

THERAVECTYS is a French biotechnology company that is developing a new generation of vaccines based on lentiviral vector technology. This breakthrough technology came from fundamental research at Institut Pasteur. It is expected to enable the prevention or effective treatment of many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers, etc. Since its creation, THERAVECTYS has been working to develop a therapeutic anti-HIV vaccine whose phase I/II clinical trial is currently under way.
Benefiting from an exclusive world licence agreement with Institut Pasteur and financial support from public authorities (Bpifrance, i.e. the former OSEO, and ANR), THERAVECTYS is continuing to
invest in research and development to fight against other pathologies. Alone or in collaboration with other pharmaceutical players, THERAVECTYS plans shortly to begin developing new candidate vaccines.


  • THERAVECTYS raises €14.7 million
    Paris, October 13th 2013

This new financing round should enable THERAVECTYS to speed up the development of its vaccines platform
and implement international collaborations

THERAVECTYS, a French biotechnology company specialized in developing vaccines using lentiviral vector technology, today announced the finalisation of a €14.7 million financing round (US$20 million).
This financing round was completed by TETHYS, the holding company owned by the BETTENCOURT family, alongside Financière IDAT (Philippe ODDO), FGP Capital and other private investors.

Becoming one of the leading players in vaccination

"We wish to give our warmest thanks to all the investors, both new and existing ones, for the confidence they have shown by taking part in this financing round. This newly raised capital will allow
THERAVECTYS to become a leader in the fields of vaccination and immunotherapy. It will enable the company to pursue the clinical development of its therapeutic anti-HIV vaccine, bring an oncology
vaccine candidate to clinical trial by 2015 and help in setting up strategic partnerships with pharmaceutical firms", says Jean-Pierre KINET, Chairman of the THERAVECTYS Board of Directors.
As Chief Executive Officer Renaud VAILLANT puts it, "This investment materialises research done by the entire THERAVECTYS team, which has worked for more than six years to develop its unique expertise in lentiviral vector technology".

The world's first use of lentiviral vectors in the field of vaccines

"The THERAVECTYS development plan presented by the management team to shareholders in 2011 forecast the world's first use of lentiviral vectors in vaccination by late 2012", says John PIETERS, the
former CEO of AMGEN France and long-standing shareholder in THERAVECTYS. He adds, "And this happened the end of 2012 with the start-up of the clinical trial of our therapeutic anti-HIV vaccine.
The team's ability to meet its deadlines and keep its commitments has persuaded me to invest in the company for the third time."2

A unique vaccine platform

Asked about the technological potential offered by THERAVECTYS, Sir Thomas McKILLOP, former CEO of ASTRAZENECA and current independent director of THERAVECTYS says: "The phase I/II clinical trial of a therapeutic anti-HIV vaccine currently under way highlights the unique potential of the THERAVECTYS vaccine platform and opens the way to building a broad portfolio of products that can rapidly be tested in clinical trials".

A biopharmaceutical company on an international scale

"By taking part in this financing round, the BETTENCOURT family supports the ambition at THERAVECTYS to develop innovative therapeutic solutions to cover unmet medical needs and meet
the major challenges facing the public health system", explains Jean-Pierre MEYERS, CEO of TETHYS. "Moreover, THERAVECTYS must continue to set up worldwide partnerships with research institutes as well as pharmaceutical companies", he adds.

About THERAVECTYS

THERAVECTYS is a French biotechnology company that is developing a new generation of vaccines based on lentiviral vector technology. This breakthrough technology came from fundamental research at Institut Pasteur. It is expected to enable the prevention or effective treatment of many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers, etc. Since its creation, THERAVECTYS has been working to develop a therapeutic anti-HIV vaccine whose phase I/II clinical trial is currently under way.
Benefiting from an exclusive world licence agreement with Institut Pasteur and financial support from public authorities (Bpifrance, i.e. the former OSEO, and ANR), THERAVECTYS is continuing to
invest in research and development to fight against other pathologies. Alone or in collaboration with other pharmaceutical players, THERAVECTYS plans shortly to begin developing new candidate vaccines.

  • THERAVECTYS receives funding of 1.2 million euros from OSEO
    Paris, May 29th 2013

OSEO, the future funding branch of bpifrance, renews its support of THERAVECTYS
to fund the Phase I/II clinical trial underway for its anti‐HIV therapeutic vaccine

THERAVECTYS, a French biotechnology company developing a new generation of vaccines, today announced it has received funding of 1.2 million euros from OSEO in the form of a repayable advance as part of the Development of Innovation assistance program (Aide au Développement de l’Innovation) (ADI).
This new support from OSEO will contribute to funding the Phase I/II clinical trials for its anti­‐HIV therapeutic vaccine based on lentiviral vector technology, currently underway.

Renaud VAILLANT, Chief Executive Officer of THERAVECTYS, states, “We are grateful to OSEO for their renewed confidence. This support helps fund the clinical trial that we initiated in November 2012. This trial, whose initial results we expect at the beginning of 2014, is a worldwide first!”
Eric VERKANT, Deputy Regional Director of OSEO for Ile-de-France Paris, emphasizes, “OSEO is a public enterprise with no equivalent in Europe whose mission helps fulfill a leading national ambition: contributing to making France a great country of innovation and of entrepreneurs. We are proud to take part in the development of THERAVECTYS, a cutting-edge company using a unique vaccination approach, striving for advances in medicine and patient care. Biotechnology companies form part of the three priority fields of our action, along with Digital and CleanTech companies.”

 

About the AIDS epidemic

The collaboration between OSEO and THERAVECTYS began in 2005 when THERAVECTYS was declared winner of the French competition to promote the creation of cutting-edge technology enterprises (Concours national d’aide à la création d’entreprises de technologies innovantes), organized by the French Ministry of Research, and was placed under OSEO management. At that time, THERAVECTYS received a grant of 322,500 euros to start up its operations.
In 2008, THERAVECTYS benefited from a hiring assistance grant of 50,000 euros from OSEO to continue hiring its scientific and technical staff.
In 2010, THERAVECTYS applied for a Development of Innovation assistance program (ADI), for which the company was granted a repayable advance of 2 million euros. The program, whose objective was to prepare the start-up of its clinical trial for anti-HIV therapeutic vaccine (production of pilot and clinical lots, regulatory pre-clinical studies, and interactions with regulatory agencies) was successfully concluded in 2012. Benefiting from the success of the 2010 ADI program, THERAVECTYS filed a new application for assistance, which was recently granted by OSEO, and is the subject of this press release.

Romain GOHAUD, Executive Director and Chief Financial Officer of THERAVECTYS, praises the quality of the exchanges between the OSEO and THERAVECTYS teams, and states, “This 1.2-million-euro aid for the Development of Innovation program provides the company with valuable support to carry out the phase I/II clinical trials for its vaccine candidate in France and Belgium. This program covers in particular the management of interactions with the clinical investigation centers, the management of the clinical CROs, and the immunological and virological analyses conducted by centralized analysis laboratories.”

The Phase I/II clinical trial sponsored by THERAVECTYS

The double-blind placebo controlled study includes 36 patients in 6 centers: 4 in France and 2 in Belgium. Through this first human trial, THERAVECTYS intends to evaluate not only the safety and tolerance of its therapeutic vaccine candidate, but also the quality and intensity of the induced immune response. The anti-HIV therapeutic vaccine developed by THERAVECTYS should allow patients treated with antiretroviral drugs to stop taking them on a sustainable and perhaps even permanent basis once vaccinated.

About THERAVECTYS:

THERAVECTYS, a biotechnology company, is developing a new generation of vaccines based on lentiviral vector technology. Built on the result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable the prevention or effective treatment of many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers, etc. Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV, for which the Phase I/II clinical trial is underway. Benefiting from an exclusive worldwide license with the Pasteur Institute and from financial support from public institutions (OSEO, ANR), THERAVECTYS is continuing its research and development efforts to combat other diseases. It plans to develop new vaccine candidates in the near future, either alone or in collaboration with other pharmaceutical laboratories.

About OSEO, future funding branch of bpifrance

A public enterprise, OSEO, future funding branch of bpifrance, gives entrepreneurs the means to develop by funding their innovative, investment, or international projects. It provides them with the necessary advice and funding at all stages of their life cycle. OSEO works closely in collaboration with a network of European, national, and regional partners to allow the riskiest cutting-edge projects to come to fruition.


  • THERAVECTYS is invited to participate in the symposium the Institut Pasteur is holding for the 30 years of research on the AIDS virus
    Paris, May 20th 2013

“30 years of HIV Science: Imagine the future Symposium1
THERAVECTYS'paper is entitled “Perfection and clinical evaluation of a new anti-HIV therapeutic vaccine based on lentiviral vectors

THERAVECTYS, a French biotechnology company that is developing a new generation of vaccines, announces that it has been selected by the Scientific Council of the Institut Pasteur to participate in the symposium devoted to the 30 years of research on the AIDS virus.
Cécile BAUCHE, the company’s Scientific Director, says, “We are currently conducting the clinical testing of an anti-HIV therapeutic vaccine based on a new vaccine approach using lentivectors. We are delighted with the Institut Pasteur’s invitation, which emphasizes the quality of our research and the interest aroused by our new generation of vaccines. This innovative technology is not limited to HIV and can find applications on many other indications.”

About the AIDS epidemic

The AIDS epidemic was identified thirty years ago, in 1981. For lack of any treatment, the first ten years of dealing with it emphasized prevention. The second decade made it possible to develop anti-viruses that could stabilise this mortal illness. Over the last ten years, the objective was to make it possible for the greatest number of patients to gain access to these medicines, including patients living in developing countries. A special accent was placed on facilitating the conditions of administering the treatments and trying to reduce the secondary effects.
This devastating pandemic has laid 30 million dead in 30 years. According to the UNAIDS 2012 report on the worldwide AIDS epidemic, 1.7 million people throughout the world have died from the consequences of AIDS and 2.5 million were newly infected in 2011. At the end of 2011, 34 million people had caught the AIDS virus worldwide, 23.5 million of whom are in Sub-Sahara Africa.
About the available treatments Anti-retroviral medicines are used in the treatment and prevention of infection by HIV. These combat the virus by limiting its proliferation in the body. More than 30 different medicines exist today, broken down mainly into three classes: Nucleoside reverse transcriptase inhibitors, non-nucleoside inhibitors and protease inhibitors. An association with a medicine of each class is usually prescribed (tritherapy).
(1) The Symposium will be held at the Institut Pasteur from Tuesday to Thursday May 21 to May 23, 28 Rue du Docteur Roux, 75015 Paris.

According to UNAIDS 2012, more than 8 million people contaminated by HIV were benefitting from an anti-retroviral therapy in low- and intermediate-income countries at the end of 2011. This has brought a 24% decrease in mortality, especially in Sub-Sahara Africa, the geographic zone most affected by the pandemic.
The current treatments available against HIV are constrictive, costly and exhibit serious secondary effects for the patient. They do not heal the illness but only slow down the advance of the infection, as long as they are taken regularly and without interruption. Current polytherapies against HIV only partially meet the problem situation of the virus’ hypervariability and the associated escape mechanism. It is all the more important to propose therapeutic alternatives as resistance to this type of treatment is beginning to appear.

An alternative to existing treatments: therapeutic vaccines

THERAVECTYS is currently conducting a clinical test of therapeutic anti-HIV vaccination. This vaccine should allow the patient to temporarily and perhaps even definitively stop all treatment. For this, we are using the original technology of lentiviral vectors. Contrary to other gene transfer vectors, these new-generation vectors have the unique capacity to induce a strong, sustainable and diversified cellular immune response that should allow the elimination of the infected cells.

About THERAVECTYS:

THERAVECTYS, a biotechnology company, has developed a new generation of vaccines based on lentiviral vector technology. Built on the result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable preventing or effectively treating many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers... Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV. This vaccine, for which the Phase I/II clinical trial is set to begin in the second half of 2012, should allow HIV-positive patients under combination therapies to discontinue and perhaps even permanently stop taking any antiretroviral treatment once vaccinated. Benefitting from an exclusive worldwide license with the Pasteur Institute and from financial support from public institutions (OSEO, ANR), THERAVECTYS is continuing its research and development efforts to combat other diseases. It plans to soon be developing new vaccine candidates, either alone or in collaboration with other pharmaceutical laboratories.

  • THERAVECTYS is granted authorization from the French & Belgian regulatory agencies to launch a Phase I/II clinical trial for its anti-HIV therapeutic vaccine candidate
    Paris, Novemember 30th 2012

The world’s first use of lentiviral vector technology in the vaccine field

THERAVECTYS, a French biotechnology company currently developing a new generation of vaccines, today announced it was granted authorization by the National Security Agency for Medicines and Health Products in France (Agence Nationale de Sécurité du Médicament et des produits de santé) and the Federal Agency for Medicines and Health Products in Belgium (Agence Fédérale des Médicaments et des Produits de Santé) to launch a phase I/II clinical trial for its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.
Renaud VAILLANT, Chief Executive Officer of THERAVECTYS states “This authorization marks a key step in the company's development. THERAVECTYS will be the first company in the world to initiate an anti-HIV therapeutic vaccination clinical trial with lentiviral vectors."

About the trial sponsored by THERAVECTYS

This double-blind placebo controlled study will include 36 patients in 6 clinical centers: 4 in France and 2 in Belgium.
Pr. Odile LAUNAY, coordinator at the Cochin-Pasteur Clinical Investigation Center based at the Cochin Hospital in Paris, France, will be the coordinating investigator of the trial. “This study should confirm the preclinical data and the ability of the vaccine candidate, based on the result of fundamental research conducted at the Pasteur Institute, to induce an immune response against HIV” says Pr. Odile LAUNAY.

A phase I/II clinical trial

With this first human trial, THERAVECTYS not only intends to evaluate the safety and tolerance of its therapeutic vaccine candidate but also to measure the quality and intensity of the induced immune response. The anti-HIV therapeutic vaccine developed by THERAVECTYS should allow patients treated with antiretroviral drugs to stop taking them on a sustainable and perhaps permanent basis once vaccinated. “We expect to enroll our first patient before the end of the year”, says Dr. Emmanuelle SABBAH-PETROVER, in charge of THERAVECTYS’ Regulatory Affairs and Clinical Trials who adds: “Our early interactions with the French, Belgian and European regulatory agencies facilitated their investigations on our clinical trial applications.”

Lentiviral vectors supporting anti-HIV vaccination

THERAVECTYS uses lentiviral vector technology to develop a new generation of vaccines. Unlike other gene transfer vectors, lentiviral vectors have the unique ability to induce a strong, sustainable and diversified cellular immune response, which should help remove infected cells.
Dr. Cécile BAUCHE, Chief Scientific Officer of THERAVECTYS states: “In 12 months, THERAVECTYS should be able to demonstrate safety and immunogenicity in humans. This expected confirmation will not only bring tremendous hope for all HIV positive patients, but it will also open a path for new developments.”

About THERAVECTYS:

THERAVECTYS, a biotechnology company, has developed a new generation of vaccines based on lentiviral vector technology. Built on the result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable preventing or effectively treating many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers... Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV. This vaccine, for which the Phase I/II clinical trial is set to begin in the second half of 2012, should allow HIV-positive patients under combination therapies to discontinue and perhaps even permanently stop taking any antiretroviral treatment once vaccinated. Benefitting from an exclusive worldwide license with the Pasteur Institute and from financial support from public institutions (OSEO, ANR), THERAVECTYS is continuing its research and development efforts to combat other diseases. It plans to soon be developing new vaccine candidates, either alone or in collaboration with other pharmaceutical laboratories.


  • THERAVECTYS raises 7.48 million euros, one of the largest funding in private equity in 2012
    Paris, September 4th 2012


With this funding, THERAVECTYS will soon be able to launch phase I/II clinical trial for its anti-HIV therapeutic vaccine.

THERAVECTYS, a biotechnology company that is developing a new generation of vaccines based on lentiviral vector technology, announced today that it has secured 7.48 million euros as of the end of H1 2012. These funds, raised exclusively from private investors, will enable THERAVECTYS to pursue the development of a new generation of vaccines, with an anti-HIV therapeutic vaccine as its first priority.
For this third funding round, Guy PAILLAUD, former executive manager of PROMODES, and John PIETERS, former CEO of AMGEN France- some of the company's historical investors - have been
joined by 10 new private investors, which include the TETHYS fund (BETTENCOURT family), Philippe ODDO and Richard HENNESSY.

Development of new vaccine candidates

In particular, this new amount of funds raised will enable the company to fund:

  • Phase I/II of the clinical trial of its anti-HIV vaccine candidate;
  • The development of new vaccine candidates based on lentiviral vector technology and concerning other indications;
  • The planning of new laboratories that are larger and can better accommodate the company’s development

"We thank our investors—both old and new—for the trust that they have placed in us. Thanks to their support, within the next two years we hope to be able to demonstrate in humans not only the safety
but also the potential effectiveness of our anti-HIV vaccine candidate," says Renaud VAILLANT, CEO at THERAVECTYS, who adds that "this funding should also allow us to continue and even strengthen
our efforts in research and development of new indications alone or in collaboration with other large pharmaceutical laboratories."

"Access to an effective treatment"

"The anti-HIV therapeutic vaccine developed by THERAVECTYS should enable HIV-positive patients under combination therapies, once vaccinated, to discontinue and perhaps even permanently stop taking any antiretroviral treatment," explains Jean-Pierre MEYERS, CEO of TETHYS. "Despite all of the progress made, funding for these antiretroviral treatments still remains a public health challenge,
without taking into account the numerous secondary effects. Development of an anti-HIV vaccine would enable providing access to effective treatment to not only those who, within developing countries which lack the resources, do not yet have access to care; but this vaccine would also relieve our health care systems that are suffering due to the economic crisis" adds Jean-Pierre MEYERS.

"A clinical trial for an anti-HIV therapy vaccine"

Guy PAILLAUD, historical shareholder in the company, adds "Today I measure the progress made by the company: THERAVECTYS would be the first company in the world to initiate a clinical trial of an anti-HIV therapeutic vaccine with lentiviral vectors. Despite the tough economic times, this fundraising is the fruit of the work performed by Renaud VAILLANT and his team."
A new therapeutic platform with a unique potential "All of the company's investors measure the potential of lentiviral vector technology and the quality of the technology platform developed by THERAVECTYS" explains Jean-Pierre KINET, CEO of the company iXLife, the first investor in THERAVECTYS. "Today, lentiviral vectors are the most powerful vectors for gene transfer. These vectors can reprogram the dendritic cells and, thus, induce an intense and diversified immune response that may enable treating not only HIV but also many other diseases, particularly cancer," he adds.
(*) Lentiviral vectors: THERAVECTYS uses lentiviral vector technology to develop a new generation of vaccines. Unlike other gene transfer vectors, lentiviral vectors have the unique ability to induce a strong, sustainable and diversified cellular immune response by endogenously stimulating dendritic cells. This breakthrough technology is expected to make it possible to prevent or effectively treat numerous diseases against which the induction of an effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic infections, cancers, etc...

 

About THERAVECTYS:

THERAVECTYS, a biotechnology company, has developed a new generation of vaccines based on lentiviral vector technology. Built on the result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable preventing or effectively treating many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers... Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV. This vaccine, for which the Phase I/II clinical trial is set to begin in the second half of 2012, should allow HIV-positive patients under combination therapies to discontinue and perhaps even permanently stop taking any antiretroviral treatment once vaccinated. Benefitting from an exclusive worldwide license with the Pasteur Institute and from financial support from public institutions (OSEO, ANR), THERAVECTYS is continuing its research and development efforts to combat other diseases. It plans to soon be developing new vaccine candidates, either alone or in collaboration with other pharmaceutical laboratories.

  • Four outstanding leaders in the pharmaceutical industry & biotechnology sector join the THERAVECTYS Board of Directors
    Paris, July 4th 2012


A spin-off from the Pasteur Institute, THERAVECTYS is developing a new generation of vaccines,
with a therapeutic vaccine against HIV as the initial application.

THERAVECTYS announced the appointment of four new directors, Pierre LEPIENNE, former Executive Vice President of Synthélabo and later Sanofi-Synthélabo, Tom McKILLOP, former CEO of Astra Zeneca, Jean STEPHENNE, former CEO of GSK Bio, the vaccine division of GlaxoSmithKline, and Judith GRECIET, CEO of BioAlliance Pharma.
These four individuals will help lead the company in its international development and clinical trial phases up through the marketing of its vaccine candidates. THERAVECTYS, a French biotechnology company, is developing a new generation of vaccines based on lentiviral vector technology. The result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable preventing or effectively treating many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers...

An innovative vaccine approach for HIV-positive patients

Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV. This vaccine, for which the Phase I/II clinical trials are scheduled for the second half of 2012, should allow HIV-positive patients under combination therapy to stop antiretroviral treatment long-term and perhaps even permanently once vaccinated. Backed by an exclusive global licensing agreement with the Pasteur Institute, THERAVECTYS continues its research and development work on new applications. Alone, or in collaboration with other pharmaceutical companies, THERAVECTYS aims to lead the future development of new vaccine candidates.

Towards industrial partnerships

“The arrival of these four directors marks a new stage in the company’s development. Their backgrounds, experience, and industry knowledge will enable the company to accelerate the formation of industrial partnerships,” said Renaud VAILLANT, CEO of THERAVECTYS. Pierre LEPIENNE (Director) is one of the founders of the Synthélabo pharmaceutical group, where he served as Executive Vice President and a member of the Board of Directors. Upon the merger of Sanofi and Synthélabo, he became Executive Vice President, Secretary, and a member of the Board of Directors of the group. Tom McKILLOP (Independent Director) Ph.D. in chemistry. In 1975, Tom McKillop joined the ICI Pharmaceuticals Group which became the Zeneca laboratory in 1994 when he took over as CEO. Following a successful merger with the Swedish laboratory Astra in 1999, he stayed on as the Group’s CEO until 2006.
Judith GRECIET (Independent Director) Ph.D. in pharmacy with an emphasis on management and pharmaceutical marketing. After a successful career with Wyeth Pharmaceuticals France (now Pfizer), LFB, Zeneca, and Pharmacia, Judith joined Eisai France in 2007 where she was the President for three years. In 2011, she joined the BioAlliance Pharma company (EPA: BIO) where she was appointed CEO in May 2011. Jean STEPHENNE (Independent Director) has served as CEO of GSK Bio, the vaccine division of the GlaxoSmithKline group, since 1991. An agronomist specializing in chemistry and bio-industry, he joined SmithKline in 1974 where he went on to become Director of vaccine production and then Director of Research and Development.

About THERAVECTYS:

THERAVECTYS, a French biotechnology company, has developed a new generation of vaccines based on lentiviral vector technology. The result of fundamental research conducted at the Pasteur Institute, this breakthrough technology is expected to enable preventing or effectively treating many diseases in which the induction of effective cellular immune response is required: viral diseases (HIV), bacterial or parasitic diseases, cancers... Since its creation, THERAVECTYS has been working on the development of a therapeutic vaccine against HIV. This vaccine, for which the Phase I/II clinical trial is scheduled for the second half of 2012, should allow HIV-positive patients under combination therapy to stop antiretroviral treatment long-term and perhaps even permanently once vaccinated. Backed by an exclusive global licensing agreement with the Pasteur Institute, THERAVECTYS continues its research and development work on new applications. Alone, or in collaboration with other pharmaceutical companies, THERAVECTYS aims to lead the future development of new vaccine candidates.