Nykode Therapeutics ASA, a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, is teaming up with the GOG Foundation, Inc. to conduct a clinical trial of their groundbreaking cancer vaccine VB10.16 in combination with an immune checkpoint inhibitor for the treatment of advanced cervical cancer. This trial, dubbed the VB-C-04 trial, will be conducted in the U.S. and will evaluate the efficacy of the combination therapies in patients with cervical cancer that have already progressed following first line treatment. To date, Nykode has reported positive interim data from the Phase 2 VB-C-02 trial in Europe, giving hope to patients with heavily pre-treated advanced cervical cancer. VB10.16 is a first-of-its-kind off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of HPV16-positive cancers.
Nykode Therapeutics is thrilled to announce that they will be launching the VB-C-04 trial in the United States, with the aim of making VB10.16 available to patients as soon as possible. Thanks to the promising interim data, this trial has the potential to provide a quick and effective pathway to helping those in need. Klaus Edvardsen, Chief Development Officer of Nykode Therapeutics, is excited to be able to offer this opportunity to patients and looks forward to seeing the results.
We are thrilled to join forces with the GOG Foundation, a leading organization with an outstanding record of bringing groundbreaking treatments to patients. With the GOG Foundation’s decades of experience in partnering with innovative companies, gynecologic oncology clinical sites, and U.S. regulators, we are confident that their expertise will help us bring our VB10.16 to those who need it as quickly and effectively as possible. We look forward to working closely with the GOG Foundation to complete our potential registrational trial, VB-C-04.
Since 1970, the GOG Foundation has been at the forefront of gynecologic cancer research, conducting over 350 clinical trials in the United States. With 400 participating sites and 115,000 patients, the results of these trials have had a major impact on the standard of care for numerous types of gynecologic cancers. The Foundation’s work is helping to improve the lives of countless women and their families.
We are excited to join forces with Nykode Therapeutics to conduct VB-C-04, an innovative study to evaluate Nykode’s therapeutic cancer vaccine for advanced cervical cancer. VB10.16 has the potential to significantly enhance the current care for patients with HPV16-positive cervical cancer who have already received initial immunotherapy. This is an area of immense unmet medical need, and while we have made headway with other treatments, we remain committed to providing our patients with the best treatment options available. We look forward to collaborating with Nykode on VB-C-04 to further our joint mission of bringing cutting-edge therapies to patients with cervical cancer and other gynecological malignancies so that they can live longer and feel better.
The VB-C-04 study is providing a much-needed opportunity to further advance cervical cancer treatment, particularly for those who have had prior experience with checkpoint therapy. As we strive to improve outcomes for our patients, this innovative approach and novel therapy offers an exciting chance to revolutionize the way we approach this disease. Under the direction of Principal Investigator Ritu Salani, MD, MBA, Director of the Division of Gynecologic Oncology at David Geffen School of Medicine at UCLA, this study is poised to dramatically improve the landscape of cervical cancer treatment and increase patient survival.
About The GOG Foundation, Inc.
For nearly half a century, the GOG Foundation has been a leading resource in the field of gynecologic oncology research, committed to promoting excellence in the quality and integrity of clinical and basic scientific research. With a multi-disciplinary approach that includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians, basic scientists, quality of life experts, data managers and administrative personnel, the GOG Foundation is dedicated to providing the best care to patients with pelvic malignancies, such as cancer of the ovary, uterus, cervix, vagina and vulva. Through its clinical trials and research findings, the GOG Foundation is striving to ensure that all women affected by gynecologic cancers receive the highest standards of care.
VB10.16 is an innovative off-the-shelf therapeutic cancer vaccine candidate in development for the treatment of HPV16-positive cancers. With positive interim results from a Phase 2 trial in cervical cancer patients, the vaccine has demonstrated a favorable safety profile and responses observed in both PD-L1 positive and negative patients. Moreover, vaccine-induced HPV16-specific T cell responses were associated with the clinical responses. In addition, the Phase 1/2a trial in pre-cancerous HPV16-induced high grade cervical intraepithelial neoplasia (HSIL; CIN 2/3) revealed a statistically significant correlation of immune responses and clinical responses, further demonstrating the potential of VB10.16.
About Cervical Cancer
Cervical cancer is a global health threat, especially for women aged 35 to 44 – the age group most commonly diagnosed with the disease. In fact, around 600,000 women are diagnosed with cervical cancer each year. Human papillomavirus (HPV) is the main cause of the disease, with HPV16 accounting for over half of all cases. Most cervical cancers are squamous cell carcinoma, arising from cells that line the bottom of the cervix, while adenocarcinomas, originating from glandular cells in the upper cervix, account for the remainder. But even in advanced stages, cervical cancer is treatable when detected early and managed effectively, offering hope and a chance at a cure.
About Nykode Therapeutics
At Nykode Therapeutics, we are revolutionizing the way we fight cancer and infectious diseases. Our modular vaccine technology is designed to target antigens to Antigen Presenting Cells, to trigger a powerful and sustained immune response. Our groundbreaking approach is transforming the field of immunotherapy and offers a potential new way to treat these dangerous diseases. We are proud to be leading the charge in the search for new treatments and cures.
Nykode’s promising pipeline of lead product candidates has shown promising results in the clinical trials. VB10.16, a therapeutic vaccine for HPV-16 induced malignancies, is being trialed for the treatment of cervical cancer and has yielded positive interim efficacy and safety results. Meanwhile, VB10.NEO, an individualized cancer neoantigen vaccine, has been exclusively out-licensed to Genentech, a member of the Roche Group. Additionally, the company is conducting a Phase 1/2 trial with next-generation COVID-19 vaccine candidates to help fight the pandemic.
The Company has forged several strategic partnerships to further its goal in the oncology and infectious disease space. These include a collaboration with Genentech, a multi-target agreement with Regeneron, and a partnership with Adaptive Biotechnologies to develop a COVID-19 T cell vaccine. Through these partnerships, the Company is committed to making a real and lasting impact on the health and wellbeing of people around the world.