FDA Fast-Tracks Syncromune's SYNC-T SV-102 for mCRPC

Syncromune Inc., a clinical-stage biopharmaceutical company headquartered in Fort Lauderdale, Florida, has recently secured a Fast Track designation from the U.S. Food and Drug Administration (FDA) for its leading therapeutic candidate, SYNC-T SV-102, aimed at treating metastatic castrate-resistant prostate cancer (mCRPC). This designation underscores the potential of SYNC-T SV-102 to address critical unmet medical needs in treating this advanced and difficult-to-manage cancer, which impacts over 40,000 men annually in the U.S. and carries a dire prognosis.

The FDA's Fast Track process is specifically designed to accelerate the development and review of drugs that treat serious conditions and fulfill unmet medical needs. This swift pathway provides Syncromune with several strategic advantages, such as more frequent interactions with the FDA, eligibility for accelerated approval, and priority review. These benefits are expected to streamline the pathway for SYNC-T SV-102, potentially bringing this vital new therapy to patients more quickly than through standard channels.

Eamonn Hobbs, Chief Executive Officer and co-founder of Syncromune, expressed optimism about the designation, viewing it as a significant milestone in the company's mission to deliver groundbreaking therapies to patients with critical needs. The Fast Track designation for SYNC-T SV-102 builds on positive Phase 1 clinical data and recent clearance of the company's Investigational New Drug (IND) application.

The SYNC-T SV-102 therapy operates as a platform therapy that integrates an in situ vaccine through partial oncolysis of a tumor, followed by the intratumoral introduction of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor. This combination strategy is aimed at both stimulating the immune system and inhibiting immune suppression, thereby activating and proliferating T cells to trigger a systemic anti-tumor response. Preliminary data from a Phase 1 study involving males with mCRPC revealed a promising overall response rate of 85%, alongside a favorable safety and tolerability profile.

Charles Link, M.D., Executive Chairman of Syncromune, highlighted the importance of the Fast Track designation, noting that it will significantly enhance the company's development goals for SYNC-T SV-102 in treating men with challenging prostate cancer cases. He emphasized the company's eagerness to commence trials at various U.S. sites later this year to further the development of SYNC-T SV-102.

Syncromune, a privately held company, is focused on developing an advanced in situ platform technology optimized for metastatic solid tumors, aiming to achieve high response rates and potentially improved survival outcomes. The company's innovative SYNC-T platform represents a novel and personalized combination of a multi-target biologic drug and device therapy. This platform is designed to synchronize patient-specific antigen T cell activation in situ, thereby enabling the immune system to detect and eradicate cancer cells throughout the body. Syncromune's leading candidates, SV-101 and SV-102, are both in the Phase 1 trial stage.

SYNC-T employs a unique combination approach, utilizing in situ vaccination through device-induced partial tumor oncolysis and subsequent intratumoral infusion of a multi-target biologic drug. This method focuses on synchronizing the release of tumor antigens with the functional activation of immune cells, aiming to combat immune suppression and activate the immune system. The activated T cells proliferate, launching a systemic anti-tumor response that targets cancer across the body.

In summary, Syncromune Inc.'s recent achievement of Fast Track designation for its leading candidate, SYNC-T SV-102, marks a critical step forward in addressing the significant unmet needs in mCRPC treatment. With promising early-phase data and the strategic advantages conferred by the Fast Track process, Syncromune is well-positioned to advance its innovative therapies, aiming to offer new hope to patients battling advanced prostate cancer.