Syncromune Announces FDA IND Clearance for SYNC-T SV-102 Immunotherapy for Metastatic Prostate Cancer

Syncromune, a clinical-stage biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SYNC-T SV-102, their leading candidate for treating metastatic castrate-resistant prostate cancer. The company aims to enroll patients for the LEGION-100 Phase 1b trial in the latter half of 2024.

SYNC-T SV-102 Therapy is an innovative treatment combining partial tumor oncolysis with a fixed-dose combination multi-target biologic drug. This therapy is intended to provide a personalized approach to treating metastatic castrate-resistant prostate cancer. Syncromune's platform, SYNC-T, is designed to handle solid tumor cancers and optimize patient-specific in situ therapy.

Eamonn Hobbs, President and CEO of Syncromune, highlighted the importance of the FDA’s clearance, emphasizing that it marks a significant milestone for the company and allows them to push forward with the clinical development of SYNC-T SV-102. Hobbs noted that recent data presented at the American Association for Cancer Research (AACR) demonstrated unprecedented response rates, showcasing the potential of SYNC-T SV-102 to transform prostate cancer treatment.

Charles Link, M.D., Executive Chairman of Syncromune, expressed excitement about advancing SYNC-T SV-102 Therapy, stating that the company is well-positioned to achieve critical milestones. Link also emphasized the broad potential of this new multi-target approach in treating metastatic solid tumor cancers.

The SYNC-T platform involves a unique combination of partial tumor oncolysis and a multi-target biologic drug that comprises four active pharmaceutical ingredients (APIs). The process begins with oncolysis through freezing, which disrupts a portion of the tumor. This disruption releases cancer-specific signals and antigens, activating the immune system and creating an in situ vaccine. Following this, a fixed-dose combination multi-target biologic drug, SV-102, is directly infused into the tumor site, further stimulating the immune system and inhibiting mechanisms that suppress immune responses. This method aims to promote T cell activation and proliferation, enabling the immune system to recognize and combat cancer throughout the body.

In a Phase 1 trial on patients with metastatic castrate-resistant prostate cancer, SYNC-T SV-102 exhibited an objective response rate (ORR) of 85%. Among the 13 evaluable subjects, there were five complete responses (CRs) and six partial responses (PRs). Additionally, 54% of the subjects showed complete resolution of their bone metastases. The treatment was well tolerated, with no significant safety concerns reported.

Syncromune is a privately held company dedicated to developing in situ platform technologies optimized for metastatic solid tumor cancers, aiming to achieve high response rates and potentially improve survival outcomes. The company's primary candidates, SV-101 and SV-102, are currently in Phase 1 trials. Syncromune is headquartered in Fort Lauderdale, FL, USA.

The SYNC-T platform is a personalized in situ combination biologic drug/device designed to activate T cells and stimulate the immune system to treat metastatic solid tumors. It combines device-induced partial oncolysis and intratumoral infusion of a multi-target biologic drug to synchronize tumor antigen release with immune cell activation. This approach aims to stimulate the immune system, counter immune suppression, and enable a systemic anti-tumor response.

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