Nykode Therapeutics ASA announced that it has expanded its collaboration with Merck Sharp & Dohme LLC (Merck & Co. Inc., Rahway, NJ, USA) to include a clinical trial collaboration and supply agreement for a phase 2 trial evaluating Nykode's wholly-owned lead candidate, VB10.16, in combination with MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). This study will enroll HPV16-positive high-risk patients with locally advanced cervical cancer undergoing chemoradiotherapy.

VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The cancer vaccine is built on Nykode's technology platform of targeting antigens to antigen presenting cells. Nykode has reported promising data from the phase 2 VB C-02 trial (NCT04405349) in heavily pre-treated cervical cancer patients receiving VB10.16 in combination with atezolizumab with a median overall survival not yet reached (estimated to 25 months at the time of analysis).

These data support Nykode's ongoing efforts with the phase 2 VB-C-04 trial (NCT06099418) in second-line recurrent/metastatic cervical cancer. Furthermore, the VB10.16 clinical development program is expanding into new indications, including head and neck cancer, for which Nykode has an existing clinical trial collaboration and supply agreement with MSD for the ongoing VB-C-03 trial (NCT06016920) evaluating VB10. 16 in combination with KEYTRUDA in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma.

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co. Inc.,Rahway, NJ, USA.