LinKinVax and Gustave Roussy Announced First Patient Dosed in Phase I/IIa Clinical Study on HPV.DCVax in HPV-positive Oropharyngeal Cancer

On September 18, 2023 LinKinVax, a clinical-stage biotechnology company focusing on innovative protein-based vaccines, and Gustave Roussy, the leading cancer centre in Europe ranked third Best Cancer Hospital in the world, reported the treatment at Gustave Roussy of the first patient in a Phase I/IIa clinical study with CD40HVac, a new therapeutic vaccine candidate for HPV-positive oropharyngeal cancer (Press release, LinKinVax, SEP 18, 2023, View Source [SID1234635227]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The objectives of the study (EUCT N° 2022-502930-25-00 – NCT06007092), sponsored by Gustave Roussy, include:

To assess the immunogenicity and safety of CD40HVac with the Poly-ICLC adjuvant (Hiltonol) against oncogenic HPV in patients with HPV-positive oropharyngeal cancer, and
To determine the recommended dose for the Phase II study, based on the vaccine candidate’s safety profile and ability to induce immune responses.
Several exploratory objectives are also planned to estimate progression-free survival and overall survival.

This multicentre study will test 2 doses of CD40HVac using a dose escalation regimen. Up to 24 patients will be recruited in this double-blind, randomised and placebo-controlled study.

Valérie Bouchara, Head of Clinical Operations at LinKinVax, commented: "This first administration is a major milestone in the development of our therapeutic cancer vaccine CD40HVac. Our teams are committed to uniting their efforts to bring significant innovations to patients with limited therapeutic options, particularly those with recurrent and/or metastatic HPV-positive cancers."

Dr Caroline Even, Head of the Head and Neck Medical Oncology Unit at Gustave Roussy added: "The CD40HVac therapeutic vaccine candidate will provide a promising addition to the existing therapeutic arsenal, once its benefit and safety have been demonstrated in patients with HPV-positive oropharyngeal cancer. We are delighted to be conducting this study."

About CD40HVac

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.