On January 19, 2023 LinKinVax, a clinical-stage biotechnology company specialized in innovative protein-based vaccines, and Gustave Roussy, first leading cancer center in Europe, ranked third Best Cancer Hospital in the world,reported 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) (Press release, LinKinVax, JAN 19, 2023, View Source [SID1234626409]).
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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.
LinKinVax develops CD40HVac, a therapeutic vaccine for HPV-associated malignancies, based on an innovative technology directly targeting dendritic cells (DC), which play a crucial role in the immune system by stimulating and regulating immune responses. A recent U.S. population-based study conducted by the Centers for Disease Control and Prevention (CDC) 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.
Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is important to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients.
Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented: "This partnership with Gustave Roussy to launch of the first phase 1 study is a crucial step for the development of our CD40HVac vaccine in immuno-oncology. It 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 the treatment of HPV related cancers".
Dr. Caroline Even, Department of Head and Neck Oncology at Gustave Roussy (Villejuif- Paris) added: "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. We hope that this first project will be inaugural of a long-standing and synergistic collaboration between LinKinVax and Gustave Roussy"