Study Demonstrated 87% Overall Response Rate in Metastatic Prostate Cancer Patients Treated with SYNC-T, a First-in-Class In Situ Personalized Immunotherapy Platform
Abstract published on podium presentation that will take place during the “Developmental Therapeutics - Immunotherapy” session on May 31, 2025, from 3:00 – 6:00pm CT at McCormick Place, Chicago
FORT LAUDERDALE, Fla. and WEST DES MOINES, Iowa, May 23, 2025 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company developing SYNC-T, an in situ platform combination immunotherapy optimized for solid tumor cancers, today announced the publication of an abstract that will be presented orally at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The abstract shares Phase 1 clinical results from a trial of SYNC-T Therapy SV-102 in patients with metastatic castration-resistant prostate cancer (mCRPC).
The data demonstrate that SYNC-T Therapy achieved an overall response rate (ORR) of 87%, including a complete response (CR) rate of 53%, in patients with metastatic castration-resistant prostate cancer or who had refused hormonal therapy. SYNC-T was well-tolerated with predominantly low-grade treatment-emergent adverse events (TEAEs).
“These data mark a significant step forward in our effort to bring a new kind of immunotherapy to the treatment of solid tumors,” said Charles J. Link, M.D., Adjunct Professor, Lankenau Institute for Medical Research and Executive Chairman of Syncromune and senior author of the study. “Prostate cancer has long been considered resistant to immunotherapy, and the response rates we’re seeing with SYNC-T in this trial appear both meaningful and encouraging. For patients who have failed conventional options, these results offer real hope, and we look forward to delivering more details during our upcoming podium presentation at this year’s ASCO meeting.”
Notably, a complete radiographic resolution of bone and soft tissue metastases was observed in all eight patients demonstrating a CR, highlighting SYNC-T’s potential to address one of the most challenging manifestations of mCRPC. More details concerning time to response, duration of response, progression free survival and overall survival will be presented at the symposium.
These encouraging clinical results have led to further study of SYNC-T Therapy SV-102, now being evaluated in a U.S., multicenter, Phase 2a trial (LEGION-100) for patients with mCRPC.
Details of the upcoming oral presentation at the ASCO meeting can be found below:
Presentation Details:
Title: Clinical responses to SYNC-T therapy: In situ personalized cancer vaccination with intratumoral immunotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC)
Abstract Number: 2504
Presenter: Ricky T. Tong, M.D., Ph.D., Clinical Assistant Professor, Lankenau Institute for Medical Research, part of Main Line Health
Date: May 31, 2025
Time: 4:12pm CT
Session Title: Developmental Therapeutics – Immunotherapy
Location: McCormick Place, Chicago, IL
About Syncromune® and SYNC-T®
Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of SYNC-T, a potentially first-in-class platform immunotherapy designed to address major unmet needs and treatment challenges of incurable metastatic solid tumor cancers. SYNC-T is an in situ personalized cancer therapy engineered to synchronize the location of three components critical to T cell activation and an anti-tumor immune response: tumor antigens, immune cells, and our multi-target biologic drug. SYNC-T features a novel proprietary device delivery system that is optimized for combination drug/device immunotherapy. First, the system lyses a portion of a target tumor to rupture tumor cells and release tumor antigens into the tumor microenvironment (TME) that help to activate the immune system. Next, the delivery system facilitates the infusion of our proprietary multi-target biologic drug directly into the tumor. This synchronization of location approach is designed to unite the three critical components together in the TME and lymphatics where the immune system optimally functions. The combination therapy targets numerous mechanisms of cancer, promoting in situ immune activation while also battling immune suppression and minimizing systemic drug exposure. The goal is to activate T cells, empowering the immune system to recognize and attack the patient’s cancer throughout the body and defend with immune memory. Our lead candidate, SYNC-T Therapy SV-102 for metastatic castration-resistant prostate cancer (mCRPC), is being evaluated in a U.S., multicenter, Phase 2a trial. For more information, please visit www.legion100trial.com.
This press release includes forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained in this press release or expressed orally in connection herewith that are not statements of historical fact may be deemed to be forward-looking statements. In some cases, forward-looking statements can be identified by phrases such as “plans,” “intends,” “believes,” “expects,” “anticipates,” “foresees,” “forecasts,” “estimates” or other words or phrases of similar import. Similarly, statements herein that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Accordingly, you should not place undue reliance on our forward-looking statements. The forward-looking statements contained in this press release or expressed orally in connection herewith are made only as of the date of this press release and we undertake no obligation to update the forward-looking statements to reflect subsequent events or circumstances, except as required by applicable law. None of Syncromune, Inc., its affiliates or their respective directors, officers, employees or agents gives any representation or warranty, express or implied, as to: (i) the achievement or reasonableness of future projections, management targets, estimates or prospects contained in this press release; or (ii) the accuracy or completeness of any information contained in this press release, any other written information or oral information provided in connection herewith or any data that any of them generates. This press release was prepared by us for informational purposes only and does not constitute an offer, or solicitation of an offer, to sell any securities at any time. None of Syncromune’s securities have been registered under the Securities Act of 1933, as amended, or any state securities law. Such securities have not been approved or disapproved by the Securities and Exchange Commission or by any state securities regulatory authority, nor has the Securities and Exchange Commission or any such state authority passed on the accuracy or adequacy of this press release. Any representation to the contrary is a criminal offense. Some of the information contained in this press release may be derived from information provided by industry sources. We believe that such information is accurate and that the sources from which it has been obtained are reliable; however, we cannot guarantee the accuracy of such information and have not independently verified such information.
Corporate Contact
Danielle Hobbs
EVP, Corporate Communications
Syncromune, Inc.
media@syncromune.com
Media Contact
Mike Tattory
LifeSci Communications
mtattory@lifescicomms.com
