Syncromune's 'Freeze and Infuse' Cancer Therapy Shows Striking Results

BASEL, SWITZERLAND – April 29, 2026 – A novel immunotherapy that combines freezing a tumor with a direct drug infusion is showing remarkable promise in treating advanced prostate cancer, a disease notoriously resistant to immune-based treatments. At the 2026 European Conference on Interventional Oncology (ECIO), clinical-stage biopharmaceutical company Syncromune®, Inc. presented compelling data on its SYNC-T™ therapy, which achieved an 87% overall response rate in a preliminary trial, sparking interest in its potential to trigger a body-wide attack on metastatic cancer.

The findings, derived from a Phase 1 study of 15 patients with metastatic castration-resistant prostate cancer (mCRPC), are significant in a field where immunotherapies have often struggled. Prostate cancer is typically considered an immunologically "cold" tumor, meaning it has a low mutation rate and limited immune cell infiltration, making it difficult for the body's own defenses to recognize and attack. Syncromune's approach aims to solve this by physically disrupting the tumor and delivering a potent biologic directly to the source.

A Two-Step Attack in a Single Procedure

The innovation behind SYNC-T lies in its integrated, minimally invasive procedure. As described by Stephen Kee, M.D., EVP at Syncromune, during the ECIO presentation, the entire therapy is delivered through a single needle-like device inserted into a target tumor under image guidance.

First, the device performs partial cryolysis, a freeze-thaw cycle that doesn't aim to destroy the entire tumor but to strategically rupture a portion of the cancer cells. This process releases a flood of patient-specific tumor antigens—the unique proteins that can flag cancer cells to the immune system. Immediately following this, the same device infuses SV-102, a proprietary multi-target drug, directly into the newly created zone of lysis.

“Today’s presentation highlights the distinct procedural logic of SYNC-T: combining partial cryolysis and intratumoral infusion through a single device using an image-guided percutaneous method,” said Dr. Kee. “This novel approach has the potential to drive systemic anti-tumor responses, including regression of metastatic lesions, while maintaining a favorable tolerability profile.”

The core principle is synchronization. By co-locating the released antigens and the SV-102 drug within the tumor microenvironment, the therapy is designed to promote their flow into regional lymphatics. This is where immune cells are trained, and the goal is to create the perfect conditions for T cell activation, effectively teaching the immune system to hunt down cancer cells throughout the body.

Striking Results and the Promise of an Abscopal Effect

The clinical data presented, while from an early-stage study, is what has captured the attention of the oncology community. In the Phase 1 trial, 53% of patients achieved a complete response, meaning all signs of their cancer disappeared. Among the 13 patients who started with bone metastases—a common and painful complication of advanced prostate cancer—seven (54%) saw all of their bone lesions resolve, a feat confirmed by imaging.

This phenomenon, where treating a single tumor leads to the regression of untreated metastases elsewhere in the body, is known as the abscopal effect. Historically a rare and unpredictable event, it is the holy grail of localized cancer therapy. Syncromune's platform is engineered specifically to provoke this systemic response reliably.

Charles Link, M.D., Executive Chairman and Chief Innovation Officer of Syncromune, framed the therapy's objective clearly. “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,” he stated. “The Phase 1 clinical findings reviewed today continue to support the potential of the SYNC-T platform.”

The therapy also demonstrated a favorable safety profile. Of the 41 treatment-emergent adverse events observed, 95% were graded as mild or moderate (Grade 1 or 2), with the most common being hematuria and fever. Crucially, no severe (Grade 4 or 5) events were reported, suggesting the intratumoral delivery method successfully limits systemic toxicity.

The Path Forward: From Promise to Proof

While the early results are compelling, the journey for SYNC-T is far from over. The small size of the Phase 1 trial (n=15) means the findings must be validated in a larger patient population. To that end, Syncromune is actively enrolling patients in its Phase 2 LEGION-100 study (NCT06533644) across multiple sites in the United States. This trial will be critical in confirming the efficacy and safety of SYNC-T Therapy SV-102 and further defining its role in the mCRPC treatment landscape.

The U.S. Food and Drug Administration (FDA) has already granted the therapy Fast Track designation, a move that can expedite the development and review of drugs intended to treat serious conditions and fill an unmet medical need. However, the path for a combination product like SYNC-T, which involves both a device and a biologic drug, is inherently complex. It requires navigating regulatory frameworks that scrutinize both components individually and as an integrated system.

If successful, the implications extend far beyond prostate cancer. The SYNC-T platform is designed to be tumor-agnostic. By using the patient's own tumor as the source of antigens, the approach could theoretically be applied to a wide range of solid tumors. The oncology world will be watching the LEGION-100 trial closely to see if this innovative 'freeze and infuse' strategy can consistently turn cold tumors hot and deliver on its promise of a powerful, personalized, and systemic anti-cancer effect.