TRGNF - Transgene expands mid-stage TG4001 cancer study

Transgene ([[TRGNF]]) announces the expansion of a randomized, controlled study with TG4001 in combination with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors.Transgene has amended the initial Phase Ib/II trial protocol to enable a more rapid start of this important Phase II study based on encouraging Phase Ib/II trial data.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.Patients will be randomized to either receive the combination regimen of TG4001 and avelumab or avelumab alone.An interim analysis will be performed after the enrollment of nearly 50 patients. Transgene expects to communicate the interim analysis data around the end of 2022, with enrollment of the first patient expected in Q2 2021.The company highlighted continued clinical collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer to conduct the expanded Phase II study.

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Transgene expands mid-stage TG4001 cancer study