Clinical Trials

Date: 2018-09-24

Type of information: Initiation of development program

phase: preclinical

Announcement: initiation of development program

Company: Transgene (France)

Product: myvacTM

Action mechanism:

  • immunotherapy product. myvacTM is a viral vector-based, individualized immunotherapy that has been developed to target solid tumors. This personalized immunotherapy product is based on the mutations that are identified in the patient’s own tumor. These mutations are highly relevant targets since they lead to the expression of tumor neoantigens which are known to trigger a stronger immune response than “classic”tumor antigens.
  • The neoantigens which are the basis for the myvacTM  approach are identified by sequencing and selected using artificial intelligence algorithms, and then integrated into the genome of the viral vector (MVA).
  •  Once administered to the patient, myvacTM triggers a cascade of immune responses against a variety of targets found in the cancer cells.
  • myvacTM differs from autologous treatments since no biological material from the patient is used in the manufacturing process and as such is much easier to manufacture; it is a truly individualized approach that uses the information that is specific to the characteristics of each patient’s tumor.To design myvacTM, Transgene and its collaborative network had to overcome many scientific and technical challenges. The network’s expertise covers all the required know-how:
  • -  Institut Curie (Cancer Immunotherapy Center, team led by Professor Amigorena) is involved in the generation of translational data and the characterization of the mechanism of action;
  • - HalioDx studies biomarkers to maximize the effectiveness of the therapy;
  • - Traaser automates, secures and manages genomic data, including predictive algorithms provided by a recognized partner in artificial intelligence;
  • - Transgene has developed a unique manufacturing pilot unit in France to vectorize neoantigens and provide myvacTM within a timeframe compatible with clinical treatment schemes.
  • Transgene holds the intellectual property of the myvacTM viral vector platform and is actively working on the translational development of this innovative technology.

Disease: solid tumors

Therapeutic area: Cancer - Oncology


Trial details:

Latest news:

  • • On September 24, 2018, Transgene, a biotechnology company that designs and develops virus-based immunotherapies against cancers and infectious diseases, announced myvacTM, an individualized, viral vector-based immunotherapy against cancer that will enter clinical development in 2019. myvacTM is designed to stimulate and educate the immune system of patients to recognize and destroy tumor cells.
  • myvacTM is expected to deliver the benefits of an individualized treatment without the disadvantages of autologous approaches (Transgene does not modify the patient’s cells but integrates the neoantigen panel into the virus). It is based on a viral strain (MVA) whose safety, tolerability, immunogenicity and efficacy have already been demonstrated in the clinic with TG4010 and TG4001. The myvacTM viral vector (MVA) has repeatedly shown that it can induce a strong immune response from the patient against the tumor antigens incorporated in its viral genome as well as an enlargement of the antitumoral immune repertoire (epitope spreading).
  • myvacTM will be administered to patients with solid tumors. Two clinical trials are being set up in Europe and in the United States, including HPV-negative head and neck cancers and ovarian cancer. These trials are expected to start in 2019.
  • The first preclinical and translational results will be presented soon at immuno-oncology conferences.




Is general: Yes