Nykode Therapeutics Announces Clinical Collaboration with MSD to Evaluate VB10.16 in Combination with KEYTRUDA® (pembrolizumab) in Patients with HPV16-Positive High-Risk Locally Advanced Cervical Cancer

OSLO, Norway, May 14, 2024 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced that it has expanded its collaboration with MSD (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.

Agnete Fredriksen, EVP, Chief Scientific Officer and Business Development, commented, "We are excited to expand our clinical development to include earlier stages of cervical cancer where there is a significant unmet medical need, and we see a huge potential for cancer vaccines. We are thrilled to continue building on our already established, highly valued collaboration with the experienced and talented team at MSD, a global leader in immuno-oncology."

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

About Nykode Therapeutics

Nykode Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies with a focus on the treatment of cancer and autoimmune diseases. Nykode’s modular vaccine technology specifically targets antigens to antigen presenting cells (APC), which have been shown to induce a broad, strong and long-lasting antigen specific immune response in cancer, which correlates with clinical responses.

Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of HPV16 induced malignancies which demonstrated favorable safety and efficacy results from its Phase 2 trial for the treatment of cervical cancer. VB10.16 is being expanded into multiple trials for treatment of head and neck cancer and cervical cancer. VB10.NEO, an individualized cancer neoantigen vaccine, is exclusively out-licensed to Genentech, a member of the Roche Group.

The Company’s partnerships include Genentech within oncology and a multi-target collaboration with Regeneron in oncology and infectious diseases.

Nykode is also utilizing its APC-targeted technology to create an inverse vaccine platform for the potential use in autoimmune disorders, organ transplant rejections, anti-drug antibody reactions and allergy.

Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics can be found at .

Forward-looking statements for Nykode Therapeutics

This announcement and any materials distributed in connection with this announcement may contain certain forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect the company's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of material factors could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.

Contact for Nykode Therapeutics ASA:

EVP, Chief Scientific Officer and Business Development, Agnete Fredriksen

Nykode Therapeutics ASA

Nykode Therapeutics ASA

Oslo Science Park

Gaustadalléen 21

N-0349 Oslo, Norway