FDA grants Fast Track designation to prostate cancer treatment


Biopharmaceutical company Syncromune has had its lead-candidate for the treatment of metastatic castrate-resistant prostate cancer (mCRPC) granted Fast Track designation by the FDA.

Syncromune’s SYNC-T SV-102 therapy is a personalised treatment that comprises of an in situ vaccine via partial oncolysis of a tumour followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumour. This combination is designed to provide both immune stimulation and block immune suppression to activate and proliferate T cells to elicit a systemic anti-tumour response.

Interim data from a Phase I study of SV-102 showed an overall response rate of 85% with a favourable safety profile and tolerability. The Fast-Track designation comes on the heels of clearance of the company’s investigational new drug (IND) application, with studies expected to begin in the US this year.

Significant unmet need in mCRPC

The Fast Track designation was granted based on the potential of SYNC-T SV-102 therapy to address the significant unmet need in treating patients with mCRPC. The designation will provide Syncromune with several benefits, including more frequent FDA interactions, eligibility for accelerated approval, and priority review.

mCRPC is an advanced form of prostate cancer affects over 40,000 men in the US and is associated with very poor prognosis.

“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,” said Eamonn Hobbs, Chief Executive Officer and Co-founder of Syncromune. “This accomplishment builds upon the foundation of positive Phase I clinical data and recent IND clearance.”

Charles Link, 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.”

Reece Armstrong, Editor, DDW

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