Transgene Granted FDA IND Clearance to Move Individualized Immunotherapy Candidate TG4050 Into Phase I for Ovarian Cancer

May 18, 2019 | Clinical Trials, Leading Pharma, Ovarian Cancer, Pharma Watch, Phase I

Transgene announced the U.S. FDA has granted for an IND, allowing the company 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.

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 his tumor. TG4050 is designed to target a panel of patient specific mutations selected using a NEC’s Neoantigen Prediction System.

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 and is expected to begin later this year.

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.

About Ovarian Cancer

Ovarian cancer is a type of cancer that begins in the ovaries. The female reproductive system contains two ovaries, one on each side of the uterus. The ovaries — each about the size of an almond — produce eggs (ova) as well as the hormones estrogen and progesterone. Ovarian cancer often goes undetected until it has spread within the pelvis and abdomen. At this late stage, ovarian cancer is more difficult to treat and is frequently fatal.

About TG4050
TG4050 is an immunotherapy designed to stimulate the immune system of patients in order to induce a response that is able to recognize and destroy tumor cells in a specific manner. This personalized immunotherapy is developed for each patient, based on mutations identified through sequencing of tumor tissue, prioritized using NEC’s Neoantigen Prediction System and delivered using the myvacTM technological platform.

About myvacTM
myvacTM is a viral vector (MVA) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. The myvacTM-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has been awarded an “Investments for the Future” funding from Bpifrance for the development of its platform myvacTM.

 About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes 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.

 About NEC Corporation
NEC Corporation is a leader in the integration of IT and network technologies that benefit businesses and people around the world. The NEC Group globally provides “Solutions for Society” that promote the safety, security, efficiency and equality of society. Under the company’s corporate message of “Orchestrating a brighter world,” NEC aims to help solve a wide range of challenging issues and to create new social value for the changing world of tomorrow. For more information, visit NEC.

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