Nykode Therapeutics Announces Topline Conclusions Affirming Prolonged Clinical Benefits from Matured Survival Data in Phase 2 C-02 Trial in Advanced Cervical Cancer

• Updated survival data from Phase 2 trial (C-02) in advanced cervical cancer affirm prolonged benefits and indicate a synergistic treatment effect of Nykode’s VB10.16 and atezolizumab (Tecentriq).
• New analysis closely mirrors previously reported positive outcome. At the time of the updated analysis, observation time for remaining patients was at least 24 months compared to at least 12 months at the previous reported outcome.

• Updated C-02 survival data support the accelerated development of VB10.16, including the potential US pivotal trial C-04 in recurrent or metastatic cervical cancer, and advancing of the program into earlier stages of cervical cancer and expanding into head and neck cancer.
• Nykode will present detailed data in a future scientific publication and at a forthcoming conference.

OSLO, Norway, March 21, 2024 (GLOBE NEWSWIRE) -- Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced key conclusions from the updated analysis from the Phase 2 VB-C-02 trial. The trial investigates the use of Nykode’s wholly-owned off-the-shelf therapeutic cancer vaccine candidate VB10.16 in combination with Roche’s checkpoint inhibitor atezolizumab in patients with recurrent or metastatic HPV16-positive cervical cancer.

The updated results, which closely mirror the previously reported positive C-02 outcomes, affirm prolonged benefits and indicate a synergistic treatment effect of VB10.16 plus atezolizumab compared to the historical controls of monotherapy with checkpoint inhibitors. The updated analysis’ observation time for the remaining patients was at least 24 months, compared to at least 12 months at the previously reported outcome.

"I am thrilled with these data which yet again underscore the strength of our Nykode technology. The strength and durability of the clinical response points to a unique and highly differentiated therapy and we continue our efforts to bring VB10.16 to patients as fast as possible. We are more confident than ever in the transformative potential of Nykode's immunotherapies," said Michael Engsig, CEO.

"Today's update is a significant milestone not just for the VB-C-02 trial but for the entire VB10.16 development program and Nykode’s technology platform at large," stated Klaus Edvardsen, Chief Development Officer. "The extended survival and sustained efficacy we're observing compared to historical data on atezolizumab monotherapy underscore our confidence in VB10.16 and the upcoming potentially registrational trial.”