Transgene's stock experienced a significant drop on the Paris Bourse after the company revealed that its Phase II trial of TG4001, a therapeutic vaccine intended for the treatment of cervical and anogenital cancers, did not meet its primary endpoint. The trial, involving 100 patients, assessed TG4001 in combination with Merck KGaA and Pfizer's Bavencio (avelumab) against Bavencio alone in patients with advanced, recurrent, or metastatic HPV16-positive anogenital cancer. The primary endpoint was improvement in progression-free survival.
The failure of the trial has led analysts at Oddo BHF to revise their price target for Transgene downwards, from €2.6 to €2.2, removing TG4001 from their valuation model.
Strategic Shift to TG4050
Despite the setback with TG4001, Transgene has indicated that its strategic focus remains on the continued development of TG4050, a personalized therapeutic vaccine currently being evaluated for the treatment of head and neck cancer following surgery.
Upcoming Data Presentation
Transgene anticipates presenting data on the median 24-month follow-up of Phase I patients in the TG4050 head and neck cancer trial at an upcoming medical congress in November. According to All Invest Securities, if the data demonstrate that fewer than 6 of the 16 patients treated with TG4050 have relapsed at 24 months, and that the outcome is better than the control bar (3 of whom had already relapsed at 18 months), this will send a strong signal about the efficacy of this personalized therapeutic vaccine approach.
