Syncromune's SYNC-T SV-102, a novel multi-target immunotherapy, is showing significant promise in treating metastatic castration-resistant prostate cancer (CRPC). Early data from a Phase 1 trial indicates an impressive 85% objective response rate among evaluable patients. This innovative approach combines device-induced partial oncolysis with intra-tumoral infusion of a multi-target drug, aiming to synchronize tumor antigen release with immune cell activation.
The LEGION-100 trial (NCT06533644), a phase 1b study, is currently evaluating SYNC-T SV-102 in patients with metastatic CRPC. The treatment involves cryoablation followed by the injection of immunotherapy directly into the tumor. This strategy is designed to leverage the immune response generated by ablative technology, enhancing it with targeted immunotherapy.
Mechanism of Action
SYNC-T SV-102 is engineered to activate T cells and stimulate the immune system to fight metastatic solid tumors. The combination of in situ vaccination and multi-target drug infusion is intended to optimize the timing and location of tumor antigen release, thereby maximizing immune cell activation.
Clinical Trial Results
Prior phase 1 data revealed that SYNC-T SV-102 produced an 85% objective response rate in 13 evaluable patients, including complete responses in 5 and partial responses in 6. Notably, complete resolution of bone metastases was observed in 54% of patients. The treatment was reported to be well-tolerated, with no significant safety concerns identified.
Regulatory Milestone
In May 2024, the FDA cleared the Investigational New Drug (IND) application for SYNC-T SV-102, allowing Syncromune to proceed with clinical trials in metastatic CRPC. This regulatory milestone underscores the potential of SYNC-T SV-102 as a first-in-class combination immunotherapy.
Expert Commentary
Dr. Jason R. Williams, President and Director of Interventional Oncology and Immunotherapy at Williams Cancer Institute, highlighted the significance of these findings. "We're seeing the ablative technology generates an immune response, and we can enhance it by injecting the drugs in there with it as well," he noted, emphasizing the potential of combining ablation with immunotherapy to improve patient outcomes.
