HPV16 Cancers Vaccine Candidate Expands Phase 2 Study

France-based Transgene announced the expansion of Phase II clinical trial of therapeutic vaccine TG4001 combined with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital cancers. Patient enrollment is expected to start in Q2 2021.

The trial will focus on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer.

The initial Phase Ib/II trial conducted in France and Spain was amended to include a randomized comparison of TG4001 with avelumab versus avelumab monotherapy in anogenital cancers. The submission of the amended protocol has been initiated in Europe. Also, Transgene received U.S. FDA clearance of the protocol under TG4001 IND.

This randomized Phase II trial will be supported by continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. Transgene retains all rights to TG4001.

Commenting on this novel investigational immunotherapy regimen, Prof. Christophe Le Tourneau, M.D., Head of the Department of Drug Development and Innovation at the Curie Institute and Principal Investigator of the trial, added: “The promising data that we generated in the Phase Ib/II part of this study, in patients without liver metastases, gives me confidence that the amended study can generate the additional data needed to confirm the treatment benefits of the combination of TG4001 and avelumab in this patient population with very limited therapeutic options.”

TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to further stimulate the infection-clearing activity of the immune system through interleukin 2.

Transgene (Euronext: TNG) is a biotechnology company focused on designing and developing targeted immunotherapies to treat cancer. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing cancer cells.