In a single-arm Phase 1 study of 15 patients with metastatic prostate cancer, Syncromune’s SYNC-T Therapy SV-102 reported an 87% overall response rate with complete responses in 53% of patients. Among the 13 patients with bone metastases at baseline, all bone lesions resolved in 7 patients (54%) by imaging. Median time to response was 2.9 months, median duration of response was 12.1 months, and median overall survival was not reached at 17.2 months of follow-up. Safety findings included 41 treatment-emergent adverse events in 13 patients, 95% of which were Grade 1–2; two immune-related Grade 2 events and two Grade 3 events were observed, with no Grade 4–5 events.
The news hook is an oral presentation at ECIO 2026 outlining the company’s device-drug procedure and the preliminary data backing it, alongside ongoing enrollment in the U.S. multicenter Phase 2 LEGION-100 trial in metastatic castration-resistant prostate cancer. The procedure pairs image-guided percutaneous partial cryolysis of a target lesion with immediate intratumoral infusion of a fixed dose of SV-102 through the same device, aiming to co-localize tumor antigens and immunomodulatory therapy within the tumor microenvironment and draining lymphatics to drive systemic responses, including regression of non-treated lesions.
Strategically, this is a bet on interventional oncology as an enabling platform for immunotherapy in a tumor type that has resisted systemic checkpoint approaches. The proposition is twofold: mechanistically, synchronize antigen release with local immune activation to improve the odds of an abscopal effect; operationally, concentrate drug at the lesion to limit systemic exposure and attendant toxicity. It also positions Syncromune adjacent to the expanding radioligand and taxane landscape in post-ARSI mCRPC, seeking a pathway that avoids the manufacturing, access, and hematologic burden associated with radiopharmaceuticals. The tension is that abscopal effects have been inconsistent across modalities, and the Phase 1 dataset is small, uncontrolled, and reliant on imaging-based assessments that can be challenging in bone-predominant disease. Moving from a tightly choreographed single-site procedure to reproducible multicenter performance is the critical test.
For sites, this approach pulls interventional radiology into the center of systemic therapy, requiring cryoablation capabilities, image-guided procedural expertise, and coordination with medical oncology and urology for patient selection and follow-up. Training, device standardization, and procedure QA will matter as much as drug supply. CROs and imaging vendors will need robust central review frameworks tailored to prostate cancer response criteria and bone lesion evaluation, along with clear attribution standards to parse procedure-related versus drug-related adverse events. Regulators will scrutinize the combination product construct and expect clarity on endpoints suited to mCRPC—beyond PSA shifts—to demonstrate systemic benefit across non-injected lesions, likely with independent blinded review. Payers will look for durability, outpatient throughput, and cost comparisons versus cabazitaxel and Lu-177 PSMA, factoring in facility and device costs.
Next steps hinge on the LEGION-100 trial’s execution: enrollment velocity across community and academic IR networks, inter-site variability in cryolysis and infusion technique, and consistency of responses in non-treated metastases. The pivotal path will likely require a randomized comparator against contemporary post-ARSI standards, with OS or rPFS aligned to PCWG criteria and imaging rigor for bone disease. Watch for protocol refinements that define lesion selection, extent of lysis, infusion parameters, and retreatment cadence, as well as biomarker plans that could de-risk patient selection or elucidate immune activation in lymphatics. If the multicenter Phase 2 reproduces the Phase 1 signal with acceptable tolerability and clear systemic activity, Syncromune can credibly pursue a combination-product dialogue on a registrational design. The unresolved questions are reproducibility, endpoint alignment in bone-dominant mCRPC, and operational scalability across IR-equipped centers—factors that will determine whether this device-enabled immunotherapy can move from conference-stage enthusiasm to a viable late-stage program.
Source link: https://www.globenewswire.com/news-release/2026/04/29/3283931/0/en/Syncromune-Inc-Presents-Innovative-SYNC-T-Combination-Immunotherapy-Approach-at-Major-European-Interventional-Oncology-Conference.html
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.
