(News Bulletin 247) – The French biotech on Monday reported the first positive results for its therapeutic vaccine TG4001, a therapy tested against anogenital cancer.

Transgene starts the week with a bang after obtaining promising results on its therapeutic vaccine against HPV16-positive anogenital cancer. The title of the biotech based in Illkirch-Graffenstaden jumped by more than 20% around 3:30 p.m., after having gained more than 37% from the first exchanges.

The company is surrounded on the stock market after announcing Monday morning that TG4001, its therapeutic cancer vaccine, could induce immune responses in patients with HPV16-positive anogenital cancers.

TG4001 is a therapeutic vaccine candidate based on a viral vector. It is currently the subject of a randomized, controlled phase II clinical trial (intermediate stage of clinical trials) comparing the combination of TG4001 plus avelumab versus avelumab alone in patients with HPV16-positive anogenital cancer. The data presented at ASCO was generated in 46 patients treated in both arms of the study. Avelumab is an immunotherapy that will stimulate the immune system to fight against cancer cells, unlike chemotherapy that attacks the tumor directly.

In these phase II trials, 58% of patients who received the TG4001 + avelumab combination showed increased immune responses against HPV antigens compared to 9% in the avelumab arm alone. At the start of the study, only 4 out of 46 patients showed an immune response against HPV virus antigens. The onset of an immune response was detected on day 43 and tended to intensify on day 85.

In addition, the study reveals that 11 of the 13 patients developed an immune response showing stabilization or even regression (partial or total). In the two case studies presented, patients who developed strong responses also showed a complete clinical response.

Transgene was delighted that the data presented “clearly demonstrate that TG4001 can induce a specific immune response against the antigens vectored in this vaccine”.

“A French battle that remains to be fought”

The biotech plans to randomize the last patient of the ongoing phase II trial in the first half of 2024, the final results of which will be communicated within the year. The company also indicates that it is working on the design of a registration-oriented clinical trial to confirm the benefit of this innovative therapeutic cancer vaccine candidate.

These results were presented in a poster at the annual meeting of the American Society of Clinical Oncology (ASCO), which is currently being held in Chicago. “We look forward to the final analysis of the ongoing randomized phase II study and the next steps to be taken by TG4001 for the benefit of patients with HPV-positive cancers”, adds Dr. Alessandro Riva, its President and CEO.

Chance of the calendar, the results of Transgene were announced, while Monday several representatives of doctors and patients called on the State to accelerate vaccination against the papillomavirus, this infection responsible for many cancers including that of the cervix. uterus. Relayed by AFP, the signatories of an appeal which brings together, among others, the National Academy of Medicine, the main learned societies concerned (cancerology, pediatrics, etc.) and patient associations consider that the eradication of cancers related to the papillomavirus is “a French battle that remains to be fought”.

HPV infections are very common but can progress to cancer, recalls the National Cancer Institute. They are responsible for 6,300 new cases of cancer per year in France, half of which (2,917) concern the cervix.