Nykode Therapeutics ASA announced an expanded clinical development plan for VB10.16, the Company's wholly-owned cancer vaccine, for the treatment of HPV16-positive cancers with high unmet need. Nykode Management will host a webcast, December 20, 2022, to discuss the development plan at 11 a.m. CET (in Norwegian) and 4 p.m. CET/10 a.m. ET (in English). VB10.16 is an off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies.

The drug candidate has reported interim data from VB-C-02, a Phase 2 trial in heavily pre-treated cervical cancer patients. The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively). The vaccine-induced significant HPV16-specific T cell responses that were associated with clinical responses.

Cervical Cancer: Nykode is planning to conduct a single arm trial, VB-C-04, with potential registrational intent in 2nd line immune checkpoint inhibitor refractory advanced cervical cancer patients. The trial will be conducted in the United States and initiated in the fourth quarter of 2023. Head and Neck Cancer: Nykode is planning to conduct an open-label, dose-finding, single arm Phase 1b/2a trial of VB10.16 in combination with pembrolizumab in patients with first line HPV16-postive, recurrent or metastatic squamous cell head and neck cancer as described in Nykode's announcement on December 6, 2022.

The trial, VB-C-03, will evaluate the overall response rate, safety, tolerability, and antigen specific immune response of the combination therapies. Nykode expects to enroll patients in Europe during the first half of 2023. Basket Trial: Nykode expects to collaborate on an investigator-initiated basket trial to evaluate VB10.16 in combination with a PD-L1 inhibitor in patients diagnosed with HPV16-positive anal, penile, vaginal and/or vulvar cancer who are no longer eligible for curative treatments.

The trial is expected to enroll patients with both PD-L1 positive and PD-L1 negative tumors. Nykode will continue to study VB10.16 in patients with PD-L1 negative tumors to investigate VB10.16's potential for a dedicated trial in such a patient population. VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of human papillomavirus type 16 (HPV16)-positive cancers.

The cancer vaccine is designed based on Nykode's Vaccibody™ technology platform of targeting antigens to antigen presenting cells. VB10.16 has reported positive interim data from a Phase 2 trial in heavily pre-treated cervical cancer patients (NCT04405349). The analysis demonstrated a favorable safety profile, with responses observed in both PD-L1 positive and negative patients (ORR 27% and 17%, respectively).

The vaccine-induced significant HPV16-specific T cell responses were associated with clinical responses. The candidate has also demonstrated favorable clinical data in a Phase 1/2a study in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) demonstrating a statistically significant correlation of immune responses and clinical responses.