TG4001
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.
Discover how TG4001 works
Ongoing clinical trial
| Indication | Clinical phase | ||
|---|---|---|---|
| HPV-positive cancers | Phase II | TG4001 + avelumab | More information |
Collaboration Agreement
Collaboration agreement with Merck KGaA, Darmstadt, Germany, under which Transgene sponsors a Phase II study.
Key publications
Le Tourneau and al., ASCO 2023, Poster
Le Tourneau and al, ESMO 2019 Poster by: Borcoman et al, Eur. J. Cancer 2023
Harper and al., Gynecologic Oncology, 2019
Press releases
- April 23, 2025 - Transgene to Provide Updated Phase I Data in a Rapid Oral Presentation on Individualized Therapeutic Cancer Vaccine TG4050 at ASCO 2025
- October 14, 2024 - Transgene Provides Update on Phase II Trial of Therapeutic Cancer Vaccine TG4001 in Recurrent or Metastatic HPV16-Positive Cervical and Anogenital Cancers
- June 5, 2023 - 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
Publications
- 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
Publication - 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.
AACR 2023
Download the poster here
Poster Presentation