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Gustave Roussy Begins Phase I/IIa Trial of Linkinvax's Vaccine for HPV-Positive Oropharyngeal Cancer

NEW YORK – Linkinvax on Monday said its partner Gustave Roussy began dosing patients in a Phase I/IIa trial of CD40HVac, a vaccine for HPV-positive oropharyngeal cancer.

CD40HVac comprises a humanized CD40 monoclonal antibody fused to HPV16 E6 and E7 oncoproteins plus Oncovir's Hiltonol (poly-ICLC) immune adjuvant.

The Gustave Roussy cancer center is sponsoring the trial under a January 2023 collaboration agreement with Paris-based Linkinvax. The researchers will assess immunogenicity and safety of the vaccine in patients with HPV-positive oropharyngeal cancer and determine a recommended Phase II dose. To be eligible for the trial, patients' tumors must test positive for HPV16 via a polymerase chain reaction-based assay.

According to the trial protocol, investigators will recruit up to 24 patients who will be randomized to one of two dosing regimens, out of which 10 will be treated with the vaccine in three injections over 24 weeks and two with placebo. The first dose level group will receive 1 mg CD40Hvac and 1 mg Hiltonol. The second group will receive 3 mg CD40HVac and 1 mg Hiltonol.

The trial includes provisions for serious adverse events. Safety data will be reviewed by an independent safety data monitoring board, and in the case of a grade 3 or higher adverse event within the trial, inclusions in the trial will be suspended and a meeting of the safety monitoring board will be convened. If a grade 5 event occurs, vaccinations will also be halted pending a meeting of the board.

The trial's primary objectives are immunological outcomes as determined by the percentage of HPV16-specific T cells present 24 hours after vaccination and identification of a safe and effective dose to recommend for Phase II studies. Exploratory objectives of the study include progression-free and overall survival.