Research & Development
Transgene Receives FDA IND Clearance for Lead MyvacIndividualized Immunotherapy, TG4050, to Commence Clinical Development in Ovarian Cancer
16 May 2019 - - French biotechnology company Transgene (Euronext Paris: TNG) has received Investigational New Drug clearance from the US Food and Drug Administration to 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, the company said.

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 recognise and destroy tumor cells.

Tumor cells accumulate mutations and each patient has a set of mutations that are unique to his tumor. TG4050 is designed to target a panel of patient specific mutations selected using a NEC's Neoantigen

The Phase 1 clinical trial will evaluate the safety and the 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.

The study, sponsored by Transgene, will be co-financed by Transgene and its partner NEC, which will also support the trial by contributing to the therapeutic vaccine design and the selection of target neoantigens (see press release dated March 5, 2019).

TG4050 is an immunotherapy designed to stimulate the immune system of patients in order to induce a response that is able to recognise and destroy tumor cells in a specific manner.

This personalised immunotherapy is developed for each patient, on the basis of mutations identified through sequencing of tumor tissue, prioritized using NEC's Neoantigen Prediction System and delivered using the myvac technological platform which allows development and manufacture of a product that is specific to the patient within time frames compatible with clinical management.

myvac is a viral vector based, individualised immunotherapy platform that has been developed by Transgene to target solid tumors.

The myvac-derived products are designed to stimulate the patient's immune system, recognise and destroy tumors using the patient's own cancer specific genetic mutations.

Transgene has set a network that combines bioengineering, digital transformation, established vectorisation know-how and unique manufacturing capabilities. Transgene has been awarded an "Investments for the Future" funding from Bpifrance for the development of its platform myvac.

NEC's neoantigen prediction utilises its proprietary AI, such as graph-based relational learning, which is combined with other sources of data to discover candidate neoantigen targets. NEC comprehensively evaluates the candidate neoantigens with a primary focus placed on its in-house MHC-binding affinity prediction.

These allow NEC to effectively prioritize the numerous candidate neoantigens identified in a single patient.

Transgene (Euronext: TNG) is a French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases.