Syncromune has dosed the first patient in its LEGION-100 Phase 2a trial for SYNC-T Therapy SV-102. This trial focuses on patients with metastatic castration-resistant prostate cancer (mCRPC) who have not responded to previous treatments. The trial will evaluate the safety, tolerability, and overall response rate of the therapy, with secondary objectives including duration of response, overall survival, and progression-free survival.
This development is crucial for the mCRPC patient population as it offers a potential new treatment avenue for those who have exhausted existing therapeutic options. The therapy’s personalized approach, combining partial tumor oncolysis with a multi-target biologic directly within the tumor microenvironment, represents a novel strategy for stimulating an immune response against the cancer. This targeted approach may offer hope where current treatments fall short.
LEGION-100 is a two-part Phase 2a trial designed to escalate and optimize the dosage of SYNC-T Therapy SV-102. The therapy utilizes a unique drug/device delivery system that first lyses a portion of the tumor to release tumor antigens and then infuses a multi-target biologic drug directly into the tumor site. This approach aims to synchronize the key components of T cell activation within the tumor microenvironment, potentially leading to a systemic anti-cancer immune response. Phase 1 study results for SYNC-T Therapy SV-102 were presented at the 2025 American Society for Clinical Oncology (ASCO) annual meeting.
The initiation of the LEGION-100 trial signifies a critical step forward for Syncromune and its personalized immunotherapy platform. Positive results from this trial could validate the SYNC-T approach and potentially lead to a new treatment paradigm for mCRPC and other solid tumor cancers. This could offer a significant advancement in the treatment landscape for patients with limited options, potentially improving survival and quality of life.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
