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
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 underour collaboration agreement covering development of individualized vaccines for a broad range of cancers.”
The VB-C-04 trial will be conducted together with GOG Foundation, a U.S.-based not-for-profit organization with expertise in bringing best-in-class new treatments to patients.
About Cervical Cancer
About Nykode Therapeutics
Nykode’s lead product candidates are VB10.16, a therapeutic vaccine for the treatment of human papilloma virus (HPV)-16 induced malignancies which demonstrated positive efficacy and safety results from its Phase 2 trial for the treatment of cervical cancer; and VB10.NEO, an individualized cancer neoantigen vaccine, which is exclusively out-licensed to Genentech, a member of the Roche Group.
The Company’s partnerships include Roche and Genentech within oncology and a multi-target collaboration with Regeneron within oncology and infectious diseases.
Nykode Therapeutics’ shares are traded on the Oslo Stock Exchange (OSE: NYKD). Further information about Nykode Therapeutics may be found at http://www.nykode.com.
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:
Chief Business Officer, Agnete Fredriksen
Nykode Therapeutics ASA
Oslo Science Park