Nykode Therapeutics ASA 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®1) 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. Atezolizumab is supplied by Roche.

Nykode retains all commercial rights to VB10.16 worldwide.