FDA accepts investigational new drug application for NMIBC immunotherapy

The acceptance allows investigators to proceed with the phase 1/2a study of the intraoperative immunotherapy SURGERx with resiquimod (STM-416).

The FDA has accepted an investigational new drug (IND) application to initiate the phase 1/2a study of the intraoperative immunotherapy SURGERx with resiquimod (STM-416), SURGE Therapeutics, the developer of the drug, announced in a news release.1 The treatment works to prevent recurrence and/or progression of non–muscle-invasive bladder cancer (NMIBC) following transurethral resection of bladder tumor (TURBT).

“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. 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,” said Michael Goldberg, PhD, CEO & Founder of SURGE, in a news release.

The immunotherapy is targeted for patients who were previously diagnosed with high-grade disease and experience recurrence. In preclinical studies, SURGERx was shown to reduce post-surgical recurrence and metastasis of NMIBC, providing a potential to improve patient survival and standard of care.

The hydrogel is designed to improve the efficacy and safety of treatment by focusing the dose on where and when it can provide the most benefit. The drug works by enabling extended, localized release of cancer immunotherapy directly into the site of tumor resection,thus reprogramming the body’s response to surgery from immunosuppressive to immunostimulatory. This may then trigger the patient’s immune system to destroy residual cancer cells.

The treatment was developed based on research conducted by a laboratory at Harvard Medical School, led by Goldberg.2,3 The study investigators found that extended local release of immunotherapy perioperatively led to a decrease in tumor recurrence and eliminated metastasis.

“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,” Seth P. Lerner, MD, FACS, professor of urology at Baylor College of Medicine in Houston, Texas, said in the news release.


1. SURGE Therapeutics receives FDA clearance of IND application to initiate phase 1/2a study on intraoperative immunotherapy for bladder cancer. News release. SURGE Therapeutics. January 4, 2023. Accessed January 5, 2023. https://www.businesswire.com/news/home/20230104005018/en/SURGE-Therapeutics-Receives-FDA-Clearance-of-IND-Application-to-Initiate-Phase-12a-Study-of-Intraoperative-Immunotherapy-in-Bladder-Cancer

2. SURGE Therapeutics raises $26M series A financing to accelerate development of introperative immunotherapy to improve surgical outcomes post-surgery. News release. SURGE Therapeutics. October 17, 2022. Accessed January 5, 2023. https://www.businesswire.com/news/home/20221017005003/en/SURGE-Therapeutics-Raises-26M-Series-A-Financing-to-Accelerate-Development-of-Intraoperative-Immunotherapy-to-Improve-Survival-Outcomes-Post-Surgery

3. Park CG, Hartl CA, Schmid D, et al. Extended release of perioperative immunotherapy prevents tumor recurrence and eliminated metastases. Harvard University Medical School. Published online March 21, 2018. Accessed January 5, 2023. doi:10.1126/scitranslmed.aar1916