On February 10, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported a collaboration with the GOG Foundation, Inc. to conduct a clinical trial of VB10.16 in combination with an immune checkpoint inhibitor for the treatment of advanced cervical cancer in the U.S (Press release, Nykode Therapeutics, FEB 10, 2023, View Source [SID1234627065]). The VB-C-04 trial will evaluate the combination therapies in patients with cervical cancer that have progressed following first line treatment. Nykode has previously reported positive interim data from the Phase 2 VB-C-02 trial in Europe in patients with heavily pre-treated advanced cervical cancer. VB10.16, wholly owned by Nykode, is a potentially first-in-class off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of HPV16-positive cancers.
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"Based on the positive interim data and in line with our potential registrational trial strategy, we look forward to starting the VB-C-04 trial in the U.S. The trial is aimed at providing a fast path to making VB10.16 available to patients," said Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics.
"We are excited to collaborate with the GOG Foundation, a leading organization with unparalleled expertise in bringing best-in-class new treatments to patients," said Michael Engsig, Chief Executive Officer of Nykode Therapeutics. "The GOG Foundation has a long history of successfully working with innovative companies, gynecologic oncology clinical sites and U.S. regulators. The advice and support from the GOG Foundation will increase the quality and facilitate the execution for bringing VB10.16 forward towards the patients in need. We look forward to engaging with the GOG Foundation on execution of the potential registrational trial, VB-C-04.
" Since 1970, the GOG Foundation has conducted more than 350 clinical trials in the U.S. with 400 participating sites and 115,000 patients. The results of the GOG Foundation’s clinical trials have influenced the standard of care for numerous malignant gynecologic neoplasms.
"We are thrilled to partner with Nykode Therapeutics to conduct VB-C-04, a ground-breaking study to investigate Nykode’s therapeutic cancer vaccine candidate for the treatment of patients with advanced cervical cancer. VB10.16, which utilizes Nykode’s unique immunotherapy platform, has the potential to meaningfully improve standard of care for patients with HPV16-positive cervical cancer whose cancer has progressed after initial immunotherapy. This clinical situation has quickly become an area of high unmet medical need, and while we have made progress with other novel therapies, we remain dedicated to maximizing our patients’ treatment options and choices. We look forward to working with Nykode on VB-C-04 to advance our shared mission of delivering transformative therapies to patients with cervical cancer and other gynecologic malignancies to help our patients live as long as possible and feel as good as possible," said Leslie Randall, MD, MAS, Cervical Cancer Advisor for the GOG Partners in the GOG Foundation.
"Despite recent advances in cervical cancer care, we still have gaps in treatment strategies, particularly those who have received prior checkpoint therapy. As we continue to explore opportunities to capitalize on recent improvements in cervical cancer outcomes, innovative approaches and novel therapies are required. The VB-C-04 study in patients with recurrent cervical cancer with prior checkpoint inhibitor experience delivers this and offers an opportunity to continue to change the landscape and survival impact for our patients," notes principal investigator of the study, Ritu Salani, MD, MBA, Director, Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA.