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, and Pfizer 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.
- November 2, 2022 - Transgene Announces Positive Interim Analysis Results of Phase II Trial Evaluating TG4001 + Avelumab vs Avelumab in HPV-Positive Anogenital Cancers
- September 27, 2022 - R&D Day: Presentations to Highlight Transgene’s Competitive Positioning, Capabilities to Engineer Novel Immunotherapies for Patients with Cancer, and Update on Initial Clinical Data
- June 24, 2021 - First patient enrolled in expanded Phase II clinical trial of TG4001 + avelumab vs avelumab alone in patients with HPV16-positive anogenital cancers
- Correlation of HPV16 Gene Status and Gene Expression With Antibody Seropositivity and TIL Status in OPSCCAdrian von Witzleben, et al. Front Oncol., January 26 2021 – Read the article Publication
- TG4001 (Tipapkinogene sovacivec) and avelumab for recurrent/metastatic (R/M) Human Papilloma Virus (HPV)-16+ cancers: clinical efficacy and immunogenicity
C. Le Tourneau et al.
Download the poster here
- Phase Ib/II trial of TG4001 (Tipapkinogene sovacivec), a therapeutic HPV-vaccine, and Avelumab in patients with recurrent/metastatic HPV16 positive cancers
Christophe Le Tourneau et al.
Download the poster here