On January 4, 2023 -SURGE Therapeutics (SURGE) reported that the U.S. Food & Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to proceed with a Phase 1/2a study of its intraoperative immunotherapy, SURGERx with resiquimod (STM-416), for prevention of recurrence and/or progression after transurethral resection of bladder tumor (TURBT) in patients with non-muscle invasive bladder cancer (NMIBC) who were previously diagnosed with high-grade disease and experience recurrence (Press release, SURGE Therapeutics, JAN 4, 2023, View Source [SID1234625851]).
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"Receiving IND clearance to advance our intraoperative immunotherapy platform into a Phase 1/2a trial in our first indication represents an important milestone as we continue to advance our pipeline," said Michael Goldberg, Ph.D., CEO & Founder of SURGE. "Surgery is presently a physical intervention only, and we believe that it should be a biochemically therapeutic intervention as well. We are excited about the prospects of our novel approach and how it can potentially improve the standard of care for cancer patients in this critical context."
"SURGE’s injectable biodegradable hydrogel enables extended, localized release of various cancer immunotherapies at the site of surgical tumor resection. We look forward to working with Michael and his team at SURGE on this initial Phase 1/2a study to advance their lead intraoperative immunotherapy candidate, STM-416, in patients with recurrent bladder cancer to improve post-resection outcomes," said Seth P. Lerner, M.D., Professor of Urology and holds the Beth and Dave Swalm Chair in Urologic Oncology, in the Scott Department of Urology, Baylor College of Medicine.
SURGE’s proprietary hydrogel has been shown in preclinical studies to reduce post-surgical recurrence and metastasis, which account for 90 percent of cancer-related deaths and have been linked to the immune suppression caused by surgery. Reprogramming the body’s response to surgery from immunosuppressive to immunostimulatory can trigger the patient’s immune system to destroy both local and distal residual cancer cells, reducing recurrence and improving survival.
The SURGERx platform is designed to improve the efficacy and safety of immunotherapy treatment, concentrating the effective dose where and when it can yield tremendous impact. It also potentially increases the number of addressable patients for highly potent molecules that are currently limited to treatment of accessible lesions via intratumoral injection.