On April 19, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the initiation of the Phase 2 clinical trial VB-C-04 (Press release, Nykode Therapeutics, APR 19, 2024, View Source [SID1234642175]). The trial evaluates VB10.16, the company’s off-the-shelf therapeutic cancer vaccine candidate for HPV16-positive cancers, alone or in combination with Roche’s checkpoint inhibitor atezolizumab (Tecentriq1) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic cervical cancer.

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Step 1 of VB-C-04 is a two-arm Phase 2 trial evaluating the efficacy and safety of VB10.16 alone or in combination with atezolizumab in patients with recurrent or metastatic cervical cancer refractory to firstline treatment with pembrolizumab plus chemotherapy +/-bevacizumab.

The Phase 2 trial (GOG-3091) will be conducted in the United States (U.S.) in collaboration with The GOG Foundation, Inc. (GOG Foundation)), a U.S. based not-for-profit organization with the purpose of promoting excellence in the quality and integrity in clinical trials in gynecologic malignancies. The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva.

Dr. Bradley Monk, Director of GOG, said "Today marks an important step forward in our efforts to advance cancer treatment with the initiation of the Phase 2 trial of VB10.16 in second line HPV16-positive cervical cancer. This is a collaborative effort between GOG and Nykode, introducing a novel and promising approach to address a significant unmet medical need. As we embark on this Phase 2 trial, we are optimistic about the potential impact on reshaping the landscape of cancer care and look forward to contributing to advancements that can make a meaningful difference in patients’ lives."

"Initiating the VB10.16 trial for HPV16-positive cervical cancer addressing a high unmet medical need, is a significant step in our clinical development strategy," said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics. "The encouraging clinical profile and favorable tolerability exhibited by VB10.16 in combination with atezolizumab among patients with advanced HPV16 positive cervical cancer observed in VB-C-02 supports our dedication to advancing VB10.16 as an innovative immunotherapy for HPV16 positive cancers."

Atezolizumab is supplied by Roche. Nykode retains all commercial rights to VB10.16 worldwide.

About VB10.16

VB10.16 is a potentially first-in-class off-the-shelf therapeutic DNA-based 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 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 at least 24 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-cancerous HPV16-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 VB10.16 in combination with MSD’s PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) in addition to the VB-C-04 trial initiated today.

About the Phase 2 Trial

The Phase 2 VB-C-04 trial (NCT06099418) is designed to evaluate the efficacy and safety of VB10.16. Step 1 is randomized and will evaluate VB10.16 as a monotherapy, and in combination with Roche’s checkpoint inhibitor atezolizumab as a second line treatment in patients with recurrent or metastatic cervical cancer. Step 1 of the trial is expected to enroll 60 patients with disease progression after combination treatment with pembrolizumab, chemotherapy +/-bevacizumab into the trial. Step 2 is intended to enroll additional patients in one cohort after reviewing the data from Step 1.

About Cervical Cancer

Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma and most other patients have adenocarcinomas. Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread.