Syncromune's SYNC-T Therapy Shows 87% Response Rate in Metastatic Prostate Cancer Phase 1 Trial
Key Insights
Syncromune (search)'s SYNC-T Therapy SV-102 (search) demonstrated an 87% overall response rate with 53% complete responses in a Phase 1 study of 15 metastatic prostate cancer (search) patients.
Among 13 patients with bone metastases (search), complete resolution of all bone lesions occurred in 7 patients (54%) as confirmed by imaging.
The therapy combines cryolysis with immunomodulatory biologic infusion through a minimally invasive procedure designed to generate systemic anti-tumor effects.
Syncromune (search)'s novel SYNC-T Therapy SV-102 (search) has demonstrated promising efficacy in a Phase 1 study of patients with metastatic prostate cancer (search), achieving an 87% overall response rate with complete responses observed in 53% of patients. The company presented these findings at a major European interventional oncology conference while advancing the therapy into a Phase 2 trial.
Phase 1 Results Show Strong Clinical Activity
In the single-arm Phase 1 study involving 15 patients with metastatic prostate cancer (search), SYNC-T Therapy SV-102 (search) showed robust clinical activity across multiple endpoints. The median time to response was 2.9 months, with a median duration of response reaching 12.1 months. Notably, median overall survival had not been reached at 17.2 months of follow-up.
The therapy demonstrated particular efficacy in treating bone metastases (search), a challenging aspect of prostate cancer management. Among the 13 patients who had bone metastases at baseline, complete resolution of all bone lesions was achieved in seven patients (54%), as confirmed by imaging studies.
Innovative Combination Approach
SYNC-T represents a potentially first-in-class platform immunotherapy that combines cryolysis with precisely coordinated immunomodulatory biologic therapy. The approach uses a proprietary needle-like device delivery system optimized for combination drug/device immunotherapy.
"SYNC-T is designed to integrate cryolysis with a precisely coordinated immunomodulatory biologic, through a streamlined minimally invasive procedure intended to generate systemic anti-tumor effects," said Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune (search).
The procedure involves two synchronized steps: first, the system lyses a portion of a target tumor via a proprietary freeze/thaw method to rupture tumor cells and release patient-specific tumor antigens into the tumor microenvironment. Next, the delivery system facilitates the infusion of a proprietary multi-target biologic drug directly into the lysed area of the tumor.
Favorable Safety Profile
The Phase 1 study demonstrated a manageable safety profile. A total of 41 treatment-emergent adverse events were observed in 13 patients, with 95% graded as 1 or 2. The most common events were hematuria and fever. Only two Grade 2 immune-related adverse events and two Grade 3 treatment-emergent adverse events were reported, with no Grade 4 or 5 events observed.
Advancing to Phase 2 Trial
Based on these encouraging Phase 1 findings, Syncromune (search) is advancing SYNC-T Therapy SV-102 (search) in the ongoing Phase 2 LEGION-100 study (NCT06533644), which is actively enrolling patients with metastatic castration-resistant prostate cancer (search) across multiple sites in the United States.
The Phase 1 clinical findings continue to support the potential of the SYNC-T platform as the company advances the Phase 2 trial and explores the broader potential of the platform across metastatic solid tumors, according to Dr. Link.
Mechanism of Action
The SYNC-T platform is engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response. This approach of location synchronization is designed to unite patient-specific tumor antigens, immune cells, and the multi-target biologic drug together in the draining lymphatics where the immune system optimally functions.
The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to activate T cells that can recognize and attack both primary and metastatic tumors throughout the body and defend with immune memory.