The Phase I/IIa trial is intended to treat head and neck cancer associated with human papillomavirus (HPV). Credit: Deposition authors: Bishop, B., Dasgupta, J., Chen, X.S.; visualisation author: User:Astrojan / commons.wikimedia.org.

Biotechnology company LinKinVax has collaborated with European cancer centre Gustave Roussy for a Phase I/IIa clinical trial of a new therapeutic vaccine candidate, CD40HVac, to treat head and neck cancer associated with human papillomavirus (HPV).

Sponsored by Gustave Roussy, the first-in-human Phase I/IIa study has been designed for evaluating the immunogenicity and safety of CD40HVac, with the Poly-ICLC adjuvant (Hiltonol), against oncogenic HPV in head and neck cancer patients.

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It will also determine the recommended dose for the Phase II study, based on the vaccine candidate’s safety profile and ability to induce immune responses.

LinKinVax stated that many other exploratory objectives are also planned for estimating progression-free survival and overall survival.

LinKinVax chief medical and scientific officer Yves Levy said: “This partnership with Gustave Roussy to launch the first Phase I study is a crucial step for the development of our CD40HVac vaccine in immuno-oncology.

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“It represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients.

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“Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to the treatment of HPV related cancers.”

The company is developing the HPV-associated malignancies therapeutic vaccine, CD40HVac, using an advanced technology that directly targets dendritic cells (DC).

It stated that these cells play an important role in the immune system by modifying and stimulating immune responses.

Dr Caroline Even from Gustave Roussy (Villejuif- Paris) Head and Neck Oncology Department said: “Both Gustave Roussy and LinKinVax place innovation at the heart of a human, scientific, and technological revolution in the fight against cancer, thereby responding to the ongoing challenge of giving patients access to the most recent treatment advances.”