Date: 2012-11-13
Type of information:
phase: 2b
Announcement: collaboration
Company: Transgene (France) EORTC (EU)
Product: TG4001
Action mechanism: TG4001 is a therapeutic vaccine based on a non-propagative, highly attenuated vaccinia vector (MVA) which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2). It has been designed to have a two-pronged antiviral approach: to alert the immune system specifically to HPV16-infected cells that have started to undergo precancerous transformation (cells presenting the HPV16 E6 and E7 antigens) and to further stimulate the infection-clearing activity of the immune system through interleukin-2.
Disease: HPV16 positive oropharyngeal squamous cell carcinomas
Therapeutic area: Cancer - Oncology
Country:
Trial details: The study will be a multinational, placebo controlled, randomized, phase 2b trial led by the EORTC in which TG4001 will be administered in combination with chemo-radiotherapy in patients with HPV16 positive OSCCs whose tumor is locally advanced (non-metastatic). The main objective of the study will be to show a reduction in the relapse rate in patients receiving TG4001 in addition to this standard of care. Approximately 200 patients should be enrolled.
Latest
news: Transgene will collaborate with the European Organization for Research and Treatment of Cancer (“EORTC”) for the conduct of a randomized phase 2b study of TG4001 in patients with HPV16 positive Oropharyngeal Squamous Cell Carcinomas (OSCCs).
The trial is scheduled to start in late 2013 and should deliver its first safety and efficacy results in 2016. Under certain conditions, to be further discussed between Transgene and EORTC, this clinical trial could be extended to a phase 3 that could serve as a registrational study for TG4001 in this indication.
Since 2011, Transgene has regained full rights to TG4001 from Roche. Clinical results (released in 2012) from a phase 2b trial conducted by Roche in 206 high grade cervical dysplasia (CIN2/3) patients demonstrated a significant level of activity of the therapeutic vaccine compared to placebo.
