On May 30, 2024 Syncromune Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T, an in situ personalized therapy platform optimized for solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SYNC-T SV-102, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (Press release, Syncromune, MAY 30, 2024, View Source [SID1234643872]).
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"Receiving clearance of our IND is a significant milestone for Syncromune and will allow us to rapidly advance the clinical development of SYNC-T SV-102," said Syncromune’s President and CEO, Eamonn Hobbs. "This clearance, following our recent presentation at AACR (Free AACR Whitepaper) of data demonstrating unprecedented response rates, underscores the potential of SYNC-T SV-102 to change the landscape of prostate cancer treatment."
"We are thrilled to obtain clearance to advance the SYNC-T SV-102 Therapy and the company is well-positioned to achieve key program milestones," added Charles Link, M.D., Syncromune’s Executive Chairman. "The prospects of this new combination multi-target approach and its broad potential applicability in the treatment of metastatic solid tumor cancers is incredibly exciting."
The SYNC-T platform is a novel and personalized in situ therapy that uses a unique combination approach of partial tumor oncolysis and a multi-target biologic drug comprised of four active pharmaceutical ingredients (APIs). First, oncolysis is performed via freezing to disrupt a portion of a target tumor which facilitates the release of cancer-specific signals and tumor antigens, activating the immune system and creating an in situ vaccine. Next, a fixed-dose combination multi-target biologic drug, SV-102, is directly infused into the tumor site. This is intended to further stimulate the immune system and block mechanisms that suppress the immune response. The combination approach is designed to promote T cell activation and proliferation, empowering the immune system to recognize and attack patient-specific cancer throughout the body.
In a Phase 1 trial conducted in metastatic castrate-resistant prostate cancer patients, SYNC-T SV-102 demonstrated an objective response rate (ORR) of 85% with five complete responses (CRs) and six partial responses (PRs) among the 13 evaluable subjects. Notably, 54% of the subjects demonstrated complete resolution of their bone metastases. The treatment was well tolerated, with a favorable side effect profile and no significant safety concerns.
For more information about Syncromune and its ongoing clinical trials, please visit www.syncromune.com.