Transgene presents immunological data demonstrating that TG4001, a novel therapeutic cancer vaccine, can induce T-cell responses against HPV16 antigens in the ongoing Phase II trial at ASCO 2023

TG4001 can induce de novo immune responses against HPV16 antigens E6 and E7 in patients with advanced HPV16-positive anogenital cancers

Patients with complete objective response showed strong vaccine-induced immunoreactivity

Transgene is preparing for a potentially registrational study

Strasbourg, France, June 5, 2023, 7:30 a.m. CET – Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, announced that new data will be presented today on TG4001. These data confirm the ability of this novel investigational therapeutic cancer vaccine to induce immune responses against HPV16 antigens, that are associated with anti-tumor response. These results have been presented in a poster at the ongoing American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

TG4001 is an investigational viral vector based therapeutic cancer vaccine. It is being evaluated in a randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors (NCT: 03260023). The data presented at ASCO were generated from 46 patients included in both arms of the trial.

TG4001 induced the priming of adaptive immunity

58% of patients receiving TG4001 + avelumab showed an increase of immune responses against HPV antigens versus 9% in the avelumab arm. At baseline, immune responses against HPV antigens were limited to 4/46 patients.  The occurrence of an immune response was detected at day 43 and tended to gain in intensity at day 85.

These data clearly demonstrate that Transgene’s TG4001 could induce a specific immune response against the antigens vectorized within this vaccine. 

11 of the 13 patients with an immune response had either stable disease, partial or complete tumor response according to RECIST criteria.

Remarkably, two case studies are presented, with patients exhibiting a strong E6 and E7 immune response while showing a complete clinical response.

Preparing for a planned potentially registrational trial in an HPV-positive indication

Transgene anticipates that the last patient will be randomized in the current Phase II clinical study in the first half of 2024. Final results will be communicated in 2024.

Transgene is working on the design of a potentially registrational trial to further confirm the benefit of this novel investigational therapeutic cancer vaccine.

Dr Alessandro Riva, MD, Chairman and CEO of Transgene, added: “We are very excited by the immunological data that we are presenting at ASCO. These data further confirm that our therapeutic vaccine TG4001 can induce clinically meaningful immune responses, that are associated with antitumor response. We look forward to the final analysis of the ongoing randomized phase 2 study and the potential next steps for TG4001 in patients with HPV positive cancers”.

The abstract and poster can be accessed on the ASCO and Transgene websites.