Nykode Therapeutics Announces Expansion of Clinical Collaboration with Roche to Evaluate VB10.16 in Combination with anti-PD-L1 in the next trial in Advanced Cervical Cancer

Potentially registrational trial with Nykode’s lead candidate VB10.16 and Roche’s atezolizumab (Tecentriq) in the U.S. is expected to be initiated 4Q 2023

OSLO, Norway, June 01, 2023 (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 the clinical collaboration and supply agreement with Roche to cover evaluation of VB10.16, Nykode’s wholly owned off-the-shelf therapeutic cancer vaccine candidate, in combination with Roche’s cancer immunotherapy atezolizumab in patients with advanced cervical cancer who have progressed on pembrolizumab plus chemotherapy +/- bevacizumab as first line treatment. The VB-C-04 trial is expected to be initiated in the U.S. in the fourth quarter of 2023 with registrational intent, which provides a potential fast-to-market path.

Under the terms of the agreement, Nykode will sponsor and fund the planned clinical trial, and Roche will provide atezolizumab. Nykode retains all commercial rights to VB10.16 worldwide.

Nykode has recently reported positive safety and efficacy results from the Phase 2 VB-C-02 trial in Europe in advanced cervical cancer patients with VB10.16 in combination with atezolizumab. The results showed an overall response rate (ORR) of 29%, median overall survival (mOS) not reached but greater than 25 months at the time of analysis, and 6.3 months median progression free survival (mPFS) in PD-L1+ patients. In the patient population most relevant for the upcoming VB-C-04 trial, PD-L1+ patients with one prior line of systemic treatment, ORR was 40% and disease control rate was 80% with mPFS of 16.9 months and mOS not reached but greater than 25 months at the time of analysis.

“We look forward to expanding our collaboration with Roche to bring the combination of VB10.16 and atezolizumab to cervical cancer patients with limited treatment options. Cervical cancer has a poor prognosis, and the recent positive clinical data from VB-C-02 has strengthened our commitment to contribute with a well-tolerated treatment that can potentially prolong the life of these women. The trial provides a potential fast path to market for VB10.16,” said Michael Engsig, CEO of Nykode Therapeutics. “Overall, the collaboration speaks to our shared confidence in the unique potential of VB10.16, the platform, and the synergy between our vaccine candidates and atezolizumab. In addition to the existing VB-C-02 and the new VB-C-04 collaboration, Roche continues to be a valuable partner under our collaboration agreement covering development of individualized vaccines for a broad range of cancers.”