On December 6, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has entered into a clinical collaboration and supply agreement with MSD (Merck & Co., Inc., Rahway, NJ, USA), to evaluate Nykode’s wholly-owned lead candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase 1/2a trial in patients with HPV16-positive head and neck cancer (Press release, Nykode Therapeutics, DEC 6, 2022, View Source [SID1234624845]).
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VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The candidate has reported interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses.
"We are thrilled to collaborate with MSD, a global leader in immuno-oncology, and to work with their highly experienced and talented scientific team," stated Agnete Fredriksen, Chief Business Officer & Co-founder of Nykode Therapeutics. "We see great potential for Nykode’s cancer vaccine in combination with MSD’s anti-PD-1 therapy to generate a potent immune response in head and neck cancer and provide a meaningful clinical benefit for patients with late-stage disease."
The open-label, dose-finding Phase 1/2a trial will evaluate the safety, immunogenicity, and anti-tumor activity of VB10.16 in combination with KEYTRUDA in patients with unresectable recurrent or metastatic HPV16-positive head and neck squamous cell carcinoma. The trial is anticipated to begin enrollment in Europe during the first half of 2023. Under the terms of the agreement, Merck will supply KEYTRUDA. Nykode retains all commercial rights to VB10.16 worldwide.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.