ERC Belgium S.A. (ERC), announced publication of its most recent efficacy data in the May 2022 edition of Frontiers in Oncology. The authors reported striking efficacy and safety of a therapeutic vaccine SITOIGANAP administered to 21 patients with recurrent glioblastoma (rGBM). Glioblastoma has a dismal prognosis with half of rGBM patients dying within 8 months of recurrence of the disease. Data presented by the authors show that treatment with Sitoiganap (also called Gliovac or ERC1671) more than doubles median overall survival to 19.6 months. This is an unprecedented level of effectiveness for a disease for which new therapies have shown no improvement in the past twenty years.
Compared to historical controls, where the majority of patients succumb to rGBM within less than a year and 2-year survival is exceedingly rare, the current study reported 1-year survival of 61% of the Sitoiganap-treated patients, and 2-year survival was 45%. As important was the observation that courses of Sitoiganap treatment were well tolerated with minimal toxicity over current therapy.
Corresponding author, Daniela Bota, MD, PhD, commented, “These results for Sitoiganap in rGBM represent the most promising responses yet seen. We are excited to accelerate the clinical development of Sitoiganap.” Dr. Bota is Vice Dean for Clinical Research UCI School of Medicine and the Team Director, UCI Health Comprehensive Brain Tumor Program.
Apostolos Stathopoulos, M.D., Ph.D., President and CEO of ERC Belgium, commented, “We are thrilled that patients with rGBM finally have access to a therapy that can achieve prolonged survival. Equally exciting is that we observe improvements in functionality and quality of life in many of the patients who responded to the treatment. We are now in a position to move ahead with confidence with the company’s clinical trial plans for the United States, as well as with other approaches to treatment that include right-to-try and compassionate use pathways, expanded access options and more, which will take place in many countries throughout the world.”