On September 9, 2026 Syncromune, Inc., a privately held clinical-stage biopharmaceutical company developing SYNC-T, an investigational in situ multi-target immunotherapy platform for solid tumors, reported that Stephen Kee, M.D., EVP, Clinical Medical & Business Operations, EMEA, presented the company’s investigational SYNC-T Therapy SV-102 approach at CIRSE 2026 in Copenhagen, Denmark.
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The presentation, titled "Cryolysis and Direct Immunotherapy Injection," reviewed the scientific and procedural rationale for combining image-guided partial tumor cryolysis with direct intratumoral immunotherapy, as well as previously reported Phase 1 clinical findings with SYNC-T Therapy SV-102 in metastatic prostate cancer.
Dr. Kee also reviewed previously reported preliminary results from Syncromune’s 15-patient Phase 1 study in metastatic prostate cancer. In this small, early-stage study, investigators reported a 100% disease control rate and an investigator-assessed overall response rate of 87%, including complete responses in 53% of patients. Independent radiological review reported an 87% overall response rate, including 40% complete responses and 47% partial responses. Study imaging showed complete resolution of bone metastases in seven of the 13 patients (54%) who had bone metastases at baseline. Across the study, 95% of reported treatment-emergent adverse events were Grade 1 or 2 with no Grade 4 or 5 reported. These preliminary results should be interpreted in light of the study’s small sample size and early-stage design. SYNC-T Therapy SV-102 remains investigational, and its safety and effectiveness have not been established. Results from this 15-patient study may not be predictive of results in larger or later-stage trials.
Prostate cancer remains difficult to treat with conventional systemic immunotherapies, underscoring the need for approaches designed to overcome local immune suppression. SYNC-T is designed to address this challenge through a localized, image-guided drug-device approach that integrates image-guided tumor intervention with direct intratumoral immunotherapy delivery. As presented at CIRSE, a portion of a target tumor undergoes partial cryolysis, disrupting tumor cells and releasing a heterogeneous population of patient-specific tumor antigens. The investigational fixed-dose, multi-target drug SV-102 is then infused directly into the treated area through the same device path.
SV-102 combines four immune modulators designed to inhibit immune-suppressive pathways while activating immune-stimulatory pathways. Combined with partial cryolysis, this approach is designed to synchronize tumor antigens, immunotherapy and immune cells within the tumor and locoregional tumor-draining lymphatics, with the goal of activating T cells capable of generating a systemic anti-tumor immune response while limiting systemic drug exposure.
"Interventional radiologists bring the imaging expertise and procedural capabilities needed to precisely access tumors throughout the body, creating an important opportunity to expand how image-guided intervention contributes to cancer treatment," said Dr. Kee, EVP, Clinical Medical & Business Operations, EMEA. "SYNC-T combines a minimally invasive local procedure with direct intratumoral immunotherapy delivery designed to generate an immune response beyond the treated tumor itself. We were pleased to share both the technical approach and our clinical experience with the CIRSE community as we continue to expand our clinical program and advance the role of interventional radiology in intratumoral immunotherapy."
"CIRSE represents an important opportunity to engage the interventional radiology community as we continue building the multidisciplinary clinical infrastructure to support SYNC-T," said Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune, and Adjunct Professor at the Lankenau Institute for Medical Research. "The encouraging preliminary findings generated in the Phase 1 study helped inform the development of LEGION-100, which is now advancing through Phase 2 dose optimization in the United States. At the same time, we are preparing to expand LEGION-100 into new regions outside the U.S."
Syncromune is currently evaluating SYNC-T Therapy SV-102 in LEGION-100 (NCT06533644), an ongoing multicenter Phase 2 trial in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following standard-of-care treatment. Part 1 dose escalation has been completed, and Part 2 dose optimization is underway.
(Press release, Syncromune, SEP 9, 2026, View Source [SID1234670707])