Therapeutic HPV16-positive Vaccine Expands Late-stage Study

The Phase II clinical trial of therapeutic HPV16-positive vaccine has been expanded announced France-based Transgene.

The expansion of a randomized, controlled study with TG4001 combined with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors will enroll patients in Q2 2021.

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.

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.

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

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.

Current treatments primarily include chemoradiotherapy. However, researchers indicate a therapeutic vaccine combined with other immunotherapeutic agents such as immune checkpoint inhibitors could provide a promising potential treatment option that would address this strong medical need.

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, commented in a press release, “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 minimal therapeutic options.”

With Transgene’s myvac® platform, therapeutic vaccination enters the field of precision medicine with novel immunotherapy tailored to each individual. The myvac® approach allows the generation of virus-based immunotherapy that encodes patient-specific mutations identified and selected by Artificial Intelligence capabilities.

Transgene (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.

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