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


The designation was approved based on interim data from a phase 1 study that assessed SV-102 among males with metastatic castrate-resistant prostate cancer (mCRPC).

The FDA has granted fast track designation to SYNC-T SV-102 therapy (Syncromune Inc.) for the treatment of metastatic castration-resistant prostate cancer (mCRPC). Study authors noted that SV-102 is segmented from Syncromune Inc.’s innovative SYNC-T platform—an on-site personalized therapy that includes a combination multi-target approach to cancer treatment to improve patients’ outcomes.1

Man Hands holding blue ribbon over blue sky, Prostate Cancer Awareness, November blue, Movember Men health awareness - Image credit: SewcreamStudio | stock.adobe.com

Image credit: SewcreamStudio | stock.adobe.com

“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, in a news release. “This accomplishment builds upon the foundation of positive Phase 1 clinical data and recent [investigational new drug] clearance.”1

According to the National Cancer Institute, CRPC is a prostate cancer that continues to grow even when the amount of testosterone in the body is reduced to very low levels. Typically, many early-stage prostate cancers need normal levels of testosterone to grow, but this differs for CRPC.2 mCRPC stops responding to hormone treatment and can be found in other parts of the body. It can spread to lymph nodes, bones, the bladder, rectum, liver, lungs, and occasionally the brain.3

The study authors noted that symptoms and signs of mCRPC can include trouble urinating, pain or blood in urine, more fatigue than normal, weight loss, shortness of breath, and bone pain. However, in some cases symptoms will not appear and it often depends on the size of the tumors or where the cancer has spread.3

Additionally, this advanced form of prostate cancer impacts more than 40,000 men in the US and is associated with poor prognosis.1

The SYNC-T SV-102 platform therapy combines an in-situ vaccine through partial oncolysis of a tumor and is then followed by intertumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor. The study authors noted that the combination can provide “immune stimulation and block immune suppression to activate and proliferate T cells to elicit a systemic anti-tumor response.”1

The fast track designation was approved based on interim data from a phase 1 study that assessed SV-102 among males with mCRPC. The results displayed an overall response rate of 85% with an encouraging safety profile and tolerability, meeting significant unmet needs among patients with mCRPC.1

“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,” said Charles Link, MD, Executive Chairman of Syncromune, in a news release.1

1. Syncromune Granted FDA Fast-Track Designation for SYNC-T SV-102 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC). GlobeNewswire. News release. July 1, 2024. Accessed July 1. https://www.globenewswire.com/news-release/2024/07/01/2906660/0/en/Syncromune-Granted-FDA-Fast-Track-Designation-for-SYNC-T-SV-102-for-the-Treatment-of-Metastatic-Castrate-Resistant-Prostate-Cancer-mCRPC.html.
2. National Cancer Institute. NCI Dictionary of Cancer Terms; Castrate-Resistant Prostate Cancer. Accessed July 1, 2024. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/castrate-resistant-prostate-cancer.
3. Urology Care. Metastatic Castration-Resistant Prostate Cancer (mCRPC) What You Should Know. 2023. Accessed July 1, 2024. mCRPC-What-You-Should-Know-Fact-Sheet%20(1).pdf.
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