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Transgene reports first promising results with TG4001 plus Avelumab in HPV-Positive cancers

Transgene posted promising result at ESMO, of TG4001 plus Bavencio (avelumab) in HPV-16 positive cancers, from a clinical trial conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer.

STRASBOURG, France–(BUSINESS WIRE)–#ESMO2019–Regulatory News:

Transgene (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, today presented promising safety and efficacy data of TG4001 in combination with avelumab (BAVENCIO®), a human anti-programmed death ligand (PD-L1) antibody, in HPV-16+ recurrent or metastatic malignancies (including oropharyngeal cancers).

These Phase 1b data have been presented in a poster (#1210P) at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain. TG4001 is a therapeutic vaccine based on a Vaccinia vector (MVA), which is engineered to express HPV-16 antigens (E6 & E7). It has been administered to more than 300 individuals in previous trials, demonstrating good safety, significant HPV clearance rate and promising efficacy results.

In the Phase 1b part of the trial, 9 heavily pretreated patients received either one of the two tested doses of TG4001 combined with a fixed dose of avelumab. The Phase 2 part of the trial started in October 2018 and will enroll 40 patients.

Key results of the Phase 1b trial are:

  • 3 of the 6 patients treated with the higher dose of TG4001 showed durable partial responses1.
  • No dose-limiting toxicity was observed, confirming a good safety profile of the combined regimen.
  • T cell responses against the HPV-16 E6 and E7 antigens were detected in patients’ blood at day 43.
  • The combination regimen was able to prime the immune system and modified positively the tumors microenvironment. Patients displayed increased immune cells infiltrates (including CD8 T cells) and an increased expression of genes associated with innate and adaptive immune response.
  • An increase in PD-L1 expression in the tumor cells was seen.

Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene, commented, “These Phase 1b results with a combination treatment regimen containing TG4001 are promising. In this heavily pretreated population, the quality of the responses, in particular the duration of the responses, and the immune changes in the tumor, give us great confidence that we will see a positive outcome from the ongoing Phase 2 part of the trial. The results also confirm our conviction that a HPV-16 targeted therapeutic vaccine would be able to stimulate the immune response, and can advantageously be combined with an immune checkpoint inhibitor. Based on these results, I believe that the combination of TG4001 and an ICI could potentially offer a much-improved treatment option than single agent immune checkpoint inhibitor for patients with HPV-16+ recurrent or metastatic malignancies. Patient accrual in the Phase 2 part of the trial is in line with our expectations and the next clinical readout is expected in 1H 2020.”

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