FDA Grants Fast-Track Designation to SYNC-T SV-102 for Prostate Cancer

The US Food and Drug Administration (FDA) has granted Fast Track designation to SYNC-T SV-102 for the personalized treatment of metastatic castrate-resistant prostate cancer (mCRPC). This innovative therapy is designed to stimulate the immune response and effectively combat cancer. Data from a Phase 1 study of SV-102 in males with mCRPC demonstrated an overall response rate of 85%, along with a favorable safety profile and tolerability.

SYNC-T SV-102 is at the forefront of Syncromune's SYNC-T platform, which integrates a unique multi-targeted approach to solid tumor cancers. The therapy combines an in situ vaccine with a partial oncolysis of the tumor, followed by an infusion of the SV-102 biologic drug directly into the affected area. The dual-action method is designed not only to stimulate the immune system but also to counteract immune suppression, fostering the proliferation of T cells capable of attacking cancer cells systemically.

According to Eamonn Hobbs, CEO and co-founder of Syncromune, this designation is a testament to the potential impact of SYNC-T SV-102. “The Fast-Track designation for SYNC-T SV-102 therapy signifies another step forward in bringing our potentially groundbreaking therapy to patients who need it most. This accomplishment builds upon the foundation of positive Phase 1 clinical data and recent IND clearance. Our therapy represents a promising advancement for patients most in need," said Hobbs.

The SYNC-T platform is designed not only to initiate an immune response but to synchronize the release of tumor antigens with the activation of immune cells, creating a powerful, targeted attack against the cancer. This approach aims to produce a systemic anti-tumor response, enabling the immune system to recognize and combat cancer throughout the body.

Dr. Charles Link, M.D., Executive Chairman of Syncromune added, “We believe that Fast-Track designation for SYNC-T SV-102 will significantly aid our development goals for this therapy for men with difficult to treat prostate cancer. We look forward to initiating trials at multiple US sites later this year to expand our efforts to develop the SYNC-T SV-102 Therapy.”