Williams Cancer Institute

FDA Fast Tracks SYNC-T SV-102 for Advanced Prostate Cancer Treatment

The FDA has granted fast track designation to SYNC-T SV-102 therapy developed by Syncromune Inc. for the treatment of metastatic castration-resistant prostate cancer (mCRPC). This therapy, which is part of Syncromune’s innovative SYNC-T platform, employs a combination multi-target approach to improve patient outcomes.

Eamonn Hobbs, CEO and co-founder of Syncromune, expressed enthusiasm over this progress, highlighting it as a significant step forward in delivering their groundbreaking therapy to patients in need. This achievement builds on positive Phase 1 clinical data and recent investigational new drug clearance.

Prostate cancer, especially in its advanced stages, poses significant challenges. According to the National Cancer Institute, CRPC is a type of prostate cancer that continues to grow despite very low levels of testosterone. Unlike early-stage prostate cancers, which typically require normal testosterone levels to grow, CRPC does not respond to hormone treatment and can metastasize to other parts of the body such as lymph nodes, bones, and organs.

Symptoms of mCRPC vary and can include difficulty urinating, pain or blood in urine, fatigue, weight loss, shortness of breath, and bone pain. However, some patients may be asymptomatic, depending on tumor size and location. This advanced form of prostate cancer affects over 40,000 men in the US and is linked to a poor prognosis.

The SYNC-T SV-102 platform uses an in-situ vaccine through partial oncolysis of a tumor, followed by intertumoral infusion of a fixed-dose multi-target biologic drug into the lysed tumor. This combination aims to stimulate the immune system and block immune suppression, thereby activating T cells to elicit a systemic anti-tumor response.

The FDA’s fast track designation was based on interim data from a Phase 1 study involving men with mCRPC, showing an overall response rate of 85% and a favorable safety profile. This designation is expected to accelerate the development of SYNC-T SV-102, with trials set to begin at multiple US sites later this year.

Charles Link, MD, Executive Chairman of Syncromune, emphasized the importance of this designation for achieving their development goals and expanding their efforts to offer effective treatment options for men with difficult-to-treat prostate cancer.

In summary, the fast track status for SYNC-T SV-102 marks a promising advancement in the fight against metastatic castration-resistant prostate cancer, offering hope for improved patient outcomes and innovative treatment approaches.


Reference:  Kennedy Ferruggia, July 1, 2024. FDA Grants Fast Track Designation to SYNC-T SV-102 for Metastatic Castration-Resistant Prostate Cancer. https://www.pharmacytimes.com/view/fda-grants-fast-track-designation-to-sync-t-sv-102-for-metastatic-castration-resistant-prostate-cancer?fbclid=IwZXh0bgNhZW0CMTAAAR0K2UATPCb3NFbN-Wz3o3Jx5hMrHeEB5z5u5h7GMFYr0H54Bo47hx2oEJQ_aem_o6C4XcTCGQ66QDpkanRoKw

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