Transgene announced that a first patient has been enrolled in a randomized, controlled Phase II study evaluating the combination of TG4001 with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors. TG4001 IS AN INVESTIGATIONAL THERAPEUTIC VACCINE TARGETING HPV-POSITIVE TUMORS, including cervical, anal, and other anogenital cancers. It is based on a Vaccinia vector, which is engineered to express HPV16 E6 and E7 antigens and interleukin 2 (IL-2). TG4001 is designed to alert the immune system specifically to cells presenting these HPV antigens and to induce a specific cellular immune response against these cancer cells. Based on promising data obtained in the Phase Ib/II part of the trial, Transgene is progressing the development of TG4001 in combination with avelumab, through a randomized Phase II trial and an extended collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab. The randomized Phase II trial is focusing on patients with recurrent or metastatic HPV16-positive anogenital cancer, including cervical, vulvar, vaginal, penile, and anal cancer, without liver metastases. In the Phase Ib/II part of the study, very encouraging clinical outcome was observed in patients without liver metastases. Patients will be randomized to either receive the combination regimen of the therapeutic vaccine TG4001 and avelumab or avelumab alone. The trial will be enrolling patients in the USA and in Europe. The primary endpoint of the trial is progression-free survival according to RECIST 1.1. Secondary endpoints include objective response rate, disease control rate, overall survival and a series of immunological parameters.