SYNC-T Therapy Shows 54% Complete Bone Metastasis Resolution in Phase 1 Prostate Cancer Trial
核心洞察
SYNC-T (搜索) therapy achieved complete resolution of bone metastases in 54% of patients with metastatic prostate cancer in a phase 1 trial presented at the Society of Urologic Oncology Annual Meeting.
The investigational in situ immunotherapy demonstrated an 87% overall response rate with 53% complete responses and 33% partial responses across 15 heavily pretreated patients.
Treatment was well tolerated with 95% of adverse events being grade 1 or 2, and no grade 4 or 5 adverse events reported in this fragile patient population.
Syncromune (搜索)'s investigational SYNC-T (搜索) therapy demonstrated remarkable efficacy in resolving bone metastases in patients with metastatic prostate cancer, according to phase 1 trial data presented at the 2025 Society of Urologic Oncology Annual Meeting in Phoenix, Arizona. Among 13 patients with skeletal metastases at baseline, seven patients (54%) achieved complete resolution of all bone metastases following treatment with the in situ platform combination therapy.
The single-arm phase 1 trial enrolled 15 patients with metastatic castration-resistant prostate cancer (mCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC). Ten patients had failed hormone therapy while five refused hormone therapy. The study achieved an overall response rate of 87%, with 8 patients (53%; 95% CI, 29-79) achieving complete responses and 5 patients (33%) demonstrating partial responses.
Novel In Situ Immunotherapy Platform
SYNC-T (搜索) consists of a minimally-invasive, image-guided outpatient procedure that begins with partial oncolysis of a target tumor to release patient-specific tumor antigens. This is immediately followed by intratumoral delivery of SV-102, a proprietary multi-target biologic drug designed to synchronize the location of tumor antigens, immune cells, and therapeutic agents in the tumor microenvironment and locoregional lymph nodes.
The platform incorporates four distinct immunomodulatory components: a PD-1 (搜索) inhibitor (abazistobart (搜索)), a CTLA-4 (搜索) inhibitor (futermestotug (搜索)), a CD40 (搜索) agonist (ciltistotug (搜索)), and a TLR9 (搜索) agonist (sitmutolimod (搜索)). This combination targets multiple cancer mechanisms while promoting immune system education and T cell activation for a systemic anti-tumor response.
Clinical Outcomes and Safety Profile
Patients received SYNC-T (搜索) every 4 weeks for a maximum of 12 cycles, with a median of 6 cycles administered. The primary prostate tumor was targeted in each treatment cycle. The median time to response was 2.9 months (range 1.8-4.8 months), and the median duration of response reached 12.1 months (range, 1.1-24.1 months).
At a median follow-up of 17 months, the survival rate was 80%, with three deaths occurring in the cohort. Median radiographic progression-free survival was 14.2 months (range, 4.8-24.1 months), while median overall survival was not reached (range, 6.1-24.6 months). Notably, 57% of responders maintained ongoing remission at the time of analysis.
The therapy demonstrated a favorable safety profile in this heavily pretreated population. Adverse events occurred in 13 patients, with 95% being grade 1 or 2. The most common adverse events were fever and hematuria. Only two grade 2 immune-related adverse events (hepatitis and hypothyroidism) and two grade 3 adverse events (urinary retention and spinal compression) were observed, with no grade 4 or 5 adverse events reported.
Addressing Unmet Clinical Need
"Bone metastases remain a clear unmet clinical challenge in metastatic prostate cancer with few durable responses, despite being present in more than 80% of advanced cases," said Charles J. Link, MD, adjunct professor at the Lankenau Institute for Medical Research and co-founder and executive chairman of Syncromune (搜索). "Data demonstrating complete resolution of bone metastases at the rates we have observed is rare in this population, and it reinforces the potential of SYNC-T (搜索) to elicit a well-tolerated, systemic immune response through an in situ approach."
Gerald Andriole, MD, chief medical officer of Syncromune (搜索) and lead investigator, emphasized the clinical significance: "For men with advanced prostate cancer, bone metastases are not only a major driver of pain and disability, but also represent one of the hardest challenges we face as clinicians. Seeing these lesions resolve in a meaningful proportion of patients treated with SYNC-T (搜索) is very encouraging."
Phase 2 Trial Expansion
Building on these promising results, Syncromune (搜索) is enrolling patients for the multicenter phase 2 LEGION-100 trial (NCT06533644) at multiple US sites, including the Michigan Institute of Urology, University of Arizona Cancer Center, University of Pittsburgh Medical Center, University of Nebraska Medical Center, and Mercy Hospital in St. Louis, with additional sites planned.