Novel Immunotherapy Moves Cancer Vaccinations into the Predictive AI Stage

France-based Transgene and NEC Corporation announced that the initial patients have been enrolled in the first-in-human trials evaluating TG4050, a therapeutic vaccine based on the myvac™ technology.

In these Phase 1 clinical trials, TG4050 is being administered to patients with head and neck cancer who have a high risk of relapse after surgery and patients with ovarian cancer after surgery and adjuvant therapy.

Announced on January 7, 2020, TG4050 has been designed to target up to 30 patient-specific neoantigens (cancer cell mutations). Transgene’s highly innovative myvac™ technology allows the generation of a virus-based immunotherapy within a very short time frame while encoding patient-specific mutations identified and selected by NEC’s Neoantigen Prediction System.

They are selected using NEC’s Neoantigen Prediction System, an advanced AI technology that has already been applied in the field of oncology.

The NCT03839524 Phase 1 clinical trial of TG4050 is enrolling patients with ovarian cancer after surgery and first-line chemotherapy. This multi-center, one-arm trial will recruit patients in the USA and in France. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.

The other Phase 1 clinical trial NCT04183166 of TG4050 is enrolling patients with newly diagnosed, locoregionally advanced, HPV negative, squamous cell carcinoma of the head and neck (SCCHN) that have received an adjuvant (first-line) therapy after surgery. 

This multi-center, open-label, randomized two arms trial will include patients in the UK and in France. Patients will receive either TG4050 monotherapy after completion of the adjuvant therapy or in combination with the standard of care at the time of recurrence. 

"As each patient’s cancer is unique, we have developed a therapy that turns their solid tumor’s genetic signature into a powerful highly specific anticancer weapon,” explained Philippe Archinard, Chairman and Chief Executive Officer of Transgene.

“We are convinced that TG4050, which is at the crossroad of immunotherapy and big data sciences, will herald the start of a new era in the fight against cancer.”

Transgene uses its expertise in viral vectorization via myvac™ to incorporate the selected neoantigen sequences in the genome of the Modified Vaccinia virus Ankara viral vector. 

The Company has also set up a unique in-house good manufacturing practice unit dedicated to the manufacturing of the individualized batches of TG4050 needed for the clinical development of this novel therapeutic vaccine.

Both studies are sponsored by Transgene and are co-financed by Transgene and NEC.

Cancer Vaccine news is published by Vax-Before-Cancer.