Nykode Therapeutics ASA 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. Nykode has a focused strategy to develop VB10.16, including a potentially US registrational trial C-04 in recurrent/metastatic cervical cancer and a C-03 trial in first-line head and neck cancer, two areas with a high unmet medical need. The company is also planning to move VB10.16 into early-stage cervical cancer.

Nykode is committed to advancing the field of immunotherapy and sharing its research findings with the broader scientific community in line with their publication guidelines. To this end, the company will present the detailed data from the Phase 2 VB -C-02 trial in a future scientific publication and at a forthcoming medical conference. Nykode wishes to thank the patients, their families and the investigators for their participation and contribution to the VB-C-02 trials.

VB-C-02 is a multi-center, single arm, open-label Phase 2 trial to assess the efficacy, immunogenicity and safety of VB10.16 in collaboration with the PD-L1 inhibitor atezolizum AB in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer; Patients received treatment with VB10.16 in combined with Roche's checkpoint inhibitor atezolizumab for up to one year. The cancer vaccine is designed based on Nykode's Vaccibody technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported promising data from a Phase 2 trial in advanced PD-L1 positive cervical cancer patients (NCT04405349) in combination with atezolizumab with mOS not reached, but greater than 25 months at the time of analysis.

The vaccine-induced significant HPV16-specific T cell responses that were correlated with clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerousHPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses. Nykode is currently investigating VB10.16 in VB-C-03, an open-label, dose-finding Phase 1/2a trial evaluating VB 10.16 in combination with MSD's PD-1 inhibitor KEYTRUDA®?

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