Paris, France-based Transgene (TNG), a biotech venture that designs and develops virus-based immunotherapies for the treatment of solid tumors, has received approval for an Investigational New Drug (IND) clearance from the FDA. They can now proceed with a Phase 1 clinical trial of its lead Myvac™ candidate TG4050 as a potential treatment for ovarian cancer patients after first-line surgery and chemotherapy.

TG4050 Background

TG4050 is an individualized MVA-based immunotherapy derived from the myvac platform. IT has been designed to stimulate and educate the immune system of patients to recognize and destroy tumor cells. Tumor cells accumulate mutations and each patient has a set of mutations that are unique to their tumor. TG4050 is designed to target a panel of patient specific mutations selected using a NEC’s Neoantigen Prediction System.

Phase I Trial

The Phase 1 trial will evaluate the safety and tolerability of TG4050 in patients with ovarian, fallopian or peritoneal serous cell carcinoma. Antitumor activity will also be measured. This multi-center, one-arm trial will recruit patients in the United States and Europe.

Transgene Background

It is a publicly traded French biotech company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Their programs utilize viral vector technology with the goal of indirectly killing infected or cancerous cells. Its lead clinical-stage programs include:

  • TG4010, a therapeutic vaccine against non-small cell lung cancer
  • Pexa-Vec, an oncolytic virus against liver cancer
  • TG4001, a therapeutic vaccine against HPV-positive head and neck cancers.

The company has several other clinical programs. With its proprietary Invir.IO TM, Transgene builds on expertise in viral vectors engineering to design a new generation of multifunctional oncolytic viruses.

MyvacTM , an individualized MVA-based immunotherapy platform designed to integrated neoantigens, completes the research portfolio.

The company has been active since 1979.

Source: AP News

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