TG4001 is a therapeutic vaccine
designed to express HPV-16 antigens
TG4001 is an innovative therapy capable of combating papillomavirus-induced cancers.
The concept behind TG4001 is to teach the immune system to recognise and destroy the cancer cells expressing HPV-16 antigens, specifically E6 and E7 antigens.
TG4001 is being evaluated in a Phase II study which aims to show superiority of the therapeutic cancer vaccine in combination with avelumab compared to avelumab alone in patients with HPV16-positive anogenital tumors without liver metastases.
Ongoing clinical trial
|HPV-positive cancers||Phase II||TG4001 + avelumab||More information|
Collaboration agreement with Merck KGaA, Darmstadt, Germany, under which Transgene sponsors a Phase II study.
Promising activity in Phase Ib/II trial (HPV-positive cancers) presented at SITC 2020
Maud Brandely and Christophe le Tourneau comment on the results
Key results of the Phase Ib/II trial are:
• The combination of TG4001 and avelumab demonstrated a clinically relevant anti-tumor activity (23.5% objective response rate) in patients with previously treated recurrent and/or metastatic HPV-related cancers.
• Presence of liver metastases has a notable impact on outcome in terms of ORR and PFS. 34.8% of the patients without liver metastases responded to the treatment and a median progression-free of 5.6 months was achieved.
• HPV-specific T-cell responses were induced. They were associated with increased levels of immune cell infiltration in the tumors.
• TG4001 can be safely combined with an immune checkpoint inhibitor.
• Combination therapy results in changes in tumor microenvironment shifting immune status from “cold” to “hot”.
• Patient follow-up is still ongoing.
• Transgene is continuing the clinical development of TG4001 in a controlled randomized Phase II study.
- September 20, 2023 - Transgene advances its innovative immunotherapy pipeline and extends financial visibility until the end of 2024
- March 15, 2023 - Transgene to Present Multiple Posters Highlighting the Potential of its Exciting Immunotherapy Pipeline at AACR 2023
- November 2, 2022 - Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers
- Phase Ib/II trial of tipapkinogene sovacivec (TG4001), a therapeutic human papillomavirus 16-vaccine, in combination with avelumab in patients with advanced human papillomavirus 16-positive cancers
C. Le Tourneau, et al.
European Journal of Cancer, July 2023 (191)
Access the article here
- Immunogenicity and clinical activity of Tipapkinogen sovacivec (TG4001), an HPV-16 cancer vaccine: a randomized phase 2 study in recurrent or metastatic (R/M) anogenital cancers
- A randomized phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) human papilloma virus (HPV)-16 positive anogenital cancers
C. Le Tourneau et al.
Download the poster here