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Therapeutic HPV Vaccine Candidate Targets Dendritic Cells

January 19, 2023 • 10:08 am CST
by Manuel Alvarez
(Precision Vaccinations)

LinKinVax and Gustave Roussy today announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV).

LinKinVax develops CD40HVac based on an innovative technology directly targeting dendritic cells, which play a crucial role in the immune system by stimulating and regulating immune responses.

Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is essential to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients, says LinkinVax.

The objectives of the study (EUCT n° 2022-502930-25-00), sponsored by Gustave Roussy, are to demonstrate the safety and immunogenicity of the CD40HVac vaccine candidate with the Poly-ICLC adjuvant (Hiltonol®) against oncogenic HPV in patients with head and neck cancer and to determine the recommended Phase 2 dose based on the safety profile of the vaccine candidate and its ability to induce immune responses.

Several exploratory objectives are also planned to estimate progression-free survival and overall survival.

Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented in a press release on January 19, 2023, "This partnership ... represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients."

"Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to treating HPV-related cancers."

A recent U.S. population-based study by the Centers for Disease Control and Prevention showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18.

LinKinVax's vaccine platform is built around a humanized monoclonal antibody fused with regions of pathogens of interest, targeting the CD40 molecule expressed by dendritic cells.

The results demonstrate this strategy's benefits due to the small number of antigens required to activate the immune system, with or without an adjuvant, and its ability to trigger a lasting cellular and humoral and immune response.

The platform also benefits from the experience and safety profile of the protein-based vaccines that have been widely used for over 30 years.