NEW YORK (Precision Oncology News) – French biotech Transgene's investigational new drug application for an individualized viral vector-based immunotherapy for ovarian cancer has been accepted by the US Food and Drug Administration, allowing the firm to move forward with Phase I studies.
TG4050 is the lead candidate utilizing Transgene's Myvac viral vector-based immunotherapy platform and is designed to recognize and destroy tumors using a patient's own cancer-specific genetic mutations.
In the multi-center, single-arm Phase I trial for TG4050, researchers will study the safety and tolerability of the immunotherapy in patients with ovarian, fallopian, or peritoneal serous cell carcinoma who have received first-line surgery and chemotherapy. Each patient in the study will have their tumor tissue sequenced to identify mutations, and a panel of mutations will be prioritized using NEC's artificial intelligence-based Neoantigen Prediction System. Then, the Myvac platform will develop and manufacture an immunotherapy specific to each patient and deliver it for cancer treatment.
Transgene and Tokyo-headquartered NEC inked a collaborative agreement last year to study NEC's neoantigen prediction system and Transgene's Myvac platform to study individualized immunotherapies in solid tumors. Under the terms of their deal, NEC and Transgene said they would co-invest in the first stage of development of an individualized immunotherapy, including clinical trials focusing on ovarian cancer and HPV-negative head and neck cancer.
The Phase I study on TG4050 will be co-financed by Transgene and NEC, and will recruit participants in the US and in Europe.