FDA awards fast track designation to SYNC-T SV-102 in mCRPC

The FDA has granted a fast track designation to SYNC-T SV-102, an investigational therapy for patients with metastatic castrate-resistant prostate cancer (mCRPC), according to a news release from Syncromune, the developer of the agent.¹

The company plans to initiate additional studies of SYNC-T SV-102 later this year.

Fast track designation is awarded to new drugs and vaccines that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. With this designation, the development process for SYNC-T SV-102 can benefit from more frequent engagement with the FDA, eligibility for accelerated approval, and priority review.

According to the company, SYNC-T SV-102 is “a platform therapy that combines an in situ vaccine via partial oncolysis of a tumor followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor.”¹

Earlier this year, the FDA cleared an investigational new drug (IND) application for SYNC-T SV-102² following the presentation of interim data from a phase 1 trial (NCT05544227) at the 2024 American Association for Cancer Research (AACR) Annual Meeting.

“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 the news release.¹ “This accomplishment builds upon the foundation of positive phase 1 clinical data and recent IND clearance.”

Overall, preliminary data from the phase 1 study showed that the therapy led to an objective response rate of 85% (11/13) among patients with mCRPC.^3,4 This included 5 complete responses and 6 partial responses among 13 evaluable patients. The 2 patients that did not experience a complete or partial response to treatment had stable disease at the time of data analysis.

Regarding safety, the therapy was well-tolerated, with minimal adverse events and no significant safety concerns. Among all patients, 6 experienced mild to moderate adverse events related to treatment, which included fever, rigors, fatigue, diaphoresis, hematuria, urinary tract infection, acute urinary retention, and hepatic enzyme elevation.

In total, the phase 1 study enrolled 15 patients with mCRPC. Most patients had diffuse bone metastases and had experienced failure with prior therapies for mCRPC. Among all patients, 60% were White, 33% were Hispanic, and 7% were Black. The median age of patients was 61 years.^3,4

For the trial, patients received SYNC-T SV-102 every 4 weeks for up to 12 cycles. Response evaluations took place every 8 weeks. The primary outcome measures for the study are safety and tolerability, as assessed from baseline to 30 days following treatment. Secondary end points are the complete response rate and partial response rate among those in the intent-to-treat population.⁵

The phase 1 trial remains ongoing, with results anticipated for the second half of 2024. The company also plans to initiate additional studies of SYNC-T SV-102 later this year.

Charles Link, MD, executive chairman of Syncromune, concluded in the news release, “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.”¹

References

1. Syncromune granted FDA fast-track designation for SYNC-T SV-102 for the treatment of metastatic castrate-resistant prostate cancer (mCRPC). News release. Syncromune. Published online and accessed July 1, 2024. https://syncromune.com/2024/07/01/syncromune-granted-fda-fast-track-designation-for-sync-t-sv-102-for-the-treatment-of-metastatic-castrate-resistant-prostate-cancer-mcrpc/

2. Syncromune Inc. announces FDA clearance of IND application for SYNC-T SV-102, a first-in-class combination multi-target immunotherapy for metastatic castrate-resistant prostate cancer. News release. Syncromune. May 30, 2024. Accessed July 1, 2024. https://syncromune.com/2024/05/30/syncromune-inc-announces-fda-clearance-of-ind-application-for-sync-t-sv-102-a-first-in-class-combination-multi-target-immunotherapy-for-metastatic-castrate-resistant-prostate-cancer/

3. Syncromune Inc. presents positive results from SYNC-T SV-102 phase 1 trial at AACR Annual Meeting 2024. News release. Syncromune. April 8, 2024. Accessed July 1, 2024. https://syncromune.com/2024/04/08/syncromune-inc-presents-positive-results-from-sync-t-sv-102-phase-1-trial-at-aacr-annual-meeting-2024/

4. A biologic drug-device combination immunotherapy shows promise for patients with metastatic prostate cancer. News release. American Association for Cancer Research. April 7, 2024. Accessed July 1, 2024. https://www.aacr.org/about-the-aacr/newsroom/news-releases/a-biologic-drug-device-combination-immunotherapy-shows-promise-for-patients-with-metastatic-prostate-cancer/

5. Phase 1 trial of SYNC-T - immunotherapy for advanced/​metastatic castration-resistant prostate cancer. ClinicalTrials.gov. Last updated April 4, 2024. https://clinicaltrials.gov/study/NCT05544227