SV-102 / Syncromune - LARVOL DELTA

Syncromune, Inc. to Present Phase 1 Data Highlighting Resolution of Bone Metastases in Metastatic Prostate Cancer Patients at the Society of Urological Oncology 26th Annual Meeting (GlobeNewswire) - "The data will be presented digitally as an electronic poster and highlights findings from the now-concluded Phase 1 study of SYNC-T Therapy SV-102 in metastatic prostate cancer, with a focus on radiographic resolution of bone metastases observed in patients who achieved complete responses."

P1 data • Castration-Resistant Prostate Cancer • Prostate Cancer

EFFECTIVE RESOLUTION OF BONE METASTASES IN PATIENTS WITH METASTATIC PROSTATE CANCER USING SYNC-T THERAPY SV-102 (SUO 2025) - P1 | "These data demonstrate initial proof of concept that prostate cancer bone metastases can be effectively treated by partial cryolysis of the primary tumor with intratumoral infusion of immunotherapeutic SV-102. SYNC-T Therapy SV-102 has an acceptable safety profile and is being further evaluated in a Phase 2 multi-center US trial. SYNC-T Therapy SV-102 potentially provides urologists with a new role in managing the treatment of metastatic prostate cancer."

Clinical • Anesthesia • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD40

LEGION-100 Phase 2 Trial Enrolling - 3rd Generation Immunotherapy for mCRPC Patients (SITC 2025) - "This session will showcase Phase 1 clinical results demonstrating safety, immune activation, and early signs of efficacy, highlighting how SYNC-T SV-102 is reshaping the therapeutic landscape for advanced prostate cancer. Largely, the symposium will spotlight the LEGION-100 Phase 2 clinical trial, now actively enrolling patients and recruiting clinical trial sites across the U.S. Investigators will share insights into the trial's design, scientific rationale, and the opportunity for institutions to partner in evaluating this cutting-edge immunotherapy."

Clinical • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical Activity and Safety of SYNC-T Therapy SV-102 in Patients with Metastatic Prostate Cancer (PCF 2025) - P1, P2 | "These data demonstrate an initial proof of concept that SV-102 can be safely administered and the metastatic prostate cancer including bone metastases can be effectively treated by partial cryolysis of the primary tumor and intratumoral infusion of immunotherapeutic SV-102. SYNC-T Therapy SV-102 has an acceptable safety profile. LEGION-100, a multi-center Phase 2 trial is currently enrolling in the US (NCT06533644)."

Clinical • Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD40

Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Williams Cancer Foundation | Active, not recruiting ➔ Completed

Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical responses to SYNC-T therapy: In situ personalized cancer vaccination with intratumoral immunotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P1 | "SYNC-T Therapy was well-tolerated achieving an 87% ORR in subjects with mCRPC or who refused ADT. These encouraging clinical results have led to further study of SYNC-T SV-102 in a US, multicenter, Phase 2a trial for subjects with mCRPC."

Clinical • Metastases • Castration-Resistant Prostate Cancer • CNS Disorders • Endocrine Disorders • Genito-urinary Cancer • Hepatology • Oncology • Prostate Cancer • Solid Tumor • CD40

Syncromune Inc. Presents Positive Results from SYNC-T Therapy SV-102 Phase 1 Metastatic Prostate Cancer Trial at ASCO 2025 (GlobeNewswire) - P1 | N=15 | NCT05544227 | "Final data showed an 87% overall response rate (ORR) and 53% complete response rate (CR) in subjects with metastatic castration resistant prostate cancer (mCRPC) or who had refused hormone therapy, which is nearly double that of current standard-of-care therapies for mCRPC. All subjects achieved disease control, highlighting the potential of SYNC-T for patients with advanced prostate cancer. The data support the recent initiation of the Company’s Phase 2a LEGION-100 trial of SYNC-T Therapy SV-102, in which the first subject has been dosed at the Michigan Institute of Urology."

P1 data • Castration-Resistant Prostate Cancer

Syncromune Announces First Patient Dosed in LEGION-100 Phase 2a Trial of SYNC-T Therapy SV-102 for Patients with Metastatic Castration-Resistant Prostate Cancer (GlobeNewswire) - "Syncromune...announced that the first patient has been successfully dosed in the LEGION-100 trial, a two-part Phase 2a Dose Escalation and Dose Optimization trial of SYNC-T Therapy SV-102 for patients diagnosed with metastatic castration-resistant prostate cancer (mCRPC) (NCT06533644)....The LEGION-100 Phase 2a trial is now enrolling patients who have mCRPC and have failed prior therapies. The primary objectives of the trial are to evaluate the safety and tolerability of SYNC-T Therapy SV-102 and measure the overall response rate (ORR)."

Trial status • Castration-Resistant Prostate Cancer

Syncromune Inc. to Present Clinical Data from SYNC-T Therapy SV-102 Phase 1 Trial at the American Society for Clinical Oncology Annual Meeting 2025 (GlobeNewswire) - "Syncromune, Inc...today announced that it will present Phase 1 clinical data at this year’s American Society for Clinical Oncology (ASCO) Annual Meeting 2025, being held in Chicago, IL from May 30 through June 3, 2025."

P1 data • Castration-Resistant Prostate Cancer

Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Williams Cancer Foundation | Trial completion date: Mar 2025 ➔ Jun 2025 | Trial primary completion date: Jan 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Syncromune Appoints Zhihong Li, Ph.D., as Chief Regulatory Affairs Officer to Lead Global Regulatory Strategy for Novel Oncology Immunotherapies (GlobeNewswire) - "Syncromune...announced the appointment of Zhihong Li, Ph.D., as Chief Regulatory Affairs Officer. Dr. Li brings 18 years of regulatory and drug development experience spanning the U.S. FDA, Pfizer, Biocytogen/Eucure and Belief Biomed. As Chief Regulatory Affairs Officer, he will oversee global regulatory strategy, ensuring compliance with FDA, EMA, and NMPA (China) requirements, and is expected to play a key role in advancing SYNC-T Therapy SV-102 through late-stage clinical development."

Clinical • Castration-Resistant Prostate Cancer • Solid Tumor

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Syncromune, Inc. | Phase classification: P1 ➔ P2 | N=28 ➔ 70

Enrollment change • Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=28 | Recruiting | Sponsor: Syncromune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Biocytogen's partner Syncromune received US$100 million in Series A financing to accelerate the development of innovative tumor immunotherapy! [Google translation] (bydrug.pharmcube.com) - "Recently, Syncromune announced the successful completion of a $100 million Series A financing. This round of financing was led by an undisclosed institutional investor, and existing investor Wasatch Equity Partners also participated. In addition, the financing also triggered the conversion of approximately $45 million in convertible bonds....Syncromune said the financing will be used to advance the Phase IIa clinical trial of its drug candidate SV-102, mainly for the treatment of mCRPC."

Financing • Metastatic Castration-Resistant Prostate Cancer

A Study of SYNC-T Therapy SV-102 in Participants With Metastatic Castrate-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Syncromune, Inc.

Metastases • New P1 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Syncromune Granted FDA Fast-Track Designation for SYNC-T SV-102 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC) (GlobeNewswire) - "Syncromune Inc...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for SYNC-T SV-102 therapy, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC)....The Fast Track designation was granted based on the potential of SYNC-T SV-102 therapy to address the significant unmet need in treating patients with mCRPC....Interim data from a Phase 1 study of SV-102 in males with mCRPC demonstrated an overall response rate of 85% with a favorable safety profile and tolerability....We look forward to initiating trials at multiple US sites later this year to expand our efforts to develop the SYNC-T SV-102 Therapy."

Fast track • New trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Syncromune, Inc. Announces FDA Clearance of IND Application for SYNC-T SV-102, a First-In-Class Combination Multi-Target Immunotherapy for Metastatic Castrate-Resistant Prostate Cancer (GlobeNewswire) - "Syncromune...announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for SYNC-T SV-102, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer....Syncromune expects to initiate enrollment of patients with metastatic castrate-resistant prostate cancer in the LEGION-100 Phase 1b trial in the second half of 2024."

IND • New P1 trial • Metastatic Castration-Resistant Prostate Cancer

Cryo-immune vaccination (CIV) by SYNC-T therapy: Preclinical modeling of a novel device-multidrug immunotherapeutic approach to eradicate advanced metastatic cancers (AACR 2024) - "As a starting point, allometric scaling was used to model dosing analogous to the proprietary ICT drug formulations SV-101 and SV-102 in clinical testing (Syncromune, Inc.). To gain initial mechanistic insights, responses will be compared in host mice that are genetically deficient in selected components of the adaptive or innate immune systems. Progress in methodological and mechanistic studies will be presented."

IO biomarker • Late-breaking abstract • Metastases • Preclinical • Breast Cancer • Oncology • Solid Tumor • CD40LG • CTLA4

Systemic responses to SYNC-T therapy: In situ personalized cancer vaccination with intratumoral infusion of multitarget immunotherapy in patients with metastatic castrate-resistant prostate cancer (mCRPC) (AACR 2024) - "SYNC-T therapy has produced a remarkably high clinical response rate of >90% ORR in mCRPC subjects. Treatment is very well tolerated, safe, and repeatable. Findings illustrate the potential of device induced intratumoral vaccination combined with intratumoral SV-102 drug candidate infusion and support the continued clinical development of SYNC-T therapy."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • CD40

Phase 1 Trial of SYNC-T - Immunotherapy for Advanced/Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: Williams Cancer Foundation | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Mar 2025

Enrollment closed • Metastases • Trial completion date • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Syncromune Inc. Presents Positive Results from SYNC-T SV-102 Phase 1 Trial at AACR Annual Meeting 2024 (GlobeNewswire) - P1 | N=15 | NCT05544227 | "Syncromune...announced the presentation of positive results from the SV-102 Phase 1 trial at the American Association for Cancer Research (AACR) Annual Meeting 2024. The trial, involving patients with metastatic castrate-resistant prostate cancer (mCRPC), showed an overall response rate (ORR) of 85%.....The Phase 1 trial enrolled 15 mCRPC subjects, most of whom had diffuse bone metastases and had experienced failure with prior therapies. Subjects received SYNC-T therapy with the SV-102 multi-target biologic drug every four weeks for up to 12 cycles with response evaluation every eight weeks. SYNC-T demonstrated an ORR of 85% with five complete responses (CRs) and six partial responses (PRs) among the 13 evaluable subjects. The treatment was well tolerated, with minimal side effects and no significant safety concerns. The trial is ongoing, with results expected in the second half of 2024."

P1 data • Metastatic Castration-Resistant Prostate Cancer

Syncromune Inc. to Present Initial Clinical Data from SYNC-T SV-102 Phase 1 as a Late-Breaker at the American Association for Cancer Research Annual Meeting 2024 (GlobeNewswire) - "Syncromune...announced that it will present late-breaking Phase 1 clinical data at this year’s American Association for Cancer Research (AACR) Annual Meeting 2024....The presentation...will include results from the SV-102 Phase 1 trial, and the therapy’s potential impact on the treatment landscape for metastatic castrate-resistant prostate cancer. This late-breaking presentation marks the first time that the Company will have publicly shared data from its clinical trials of the SYNC-T therapy platform."

Late-breaking abstract • P1 data • Metastatic Castration-Resistant Prostate Cancer