Oslo, Norway, April 19, 2024 – Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, today announced the initiation of the Phase 2 clinical trial VB-C-04. 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 (Tecentriq®) in patients with HPV16-positive, PD-L1-positive, recurrent, or metastatic cervical cancer.
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 first-line 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.