Syncromune® Inc. Presents Positive Results from SYNC-T™ SV-102 Phase 1 Trial at AACR Annual Meeting 2024

Syncromune ® Inc. today announced the presentation of positive results from the SV-102 Phase 1 trial at the American Association for Cancer Research Annual Meeting 2024.

Initial clinical data demonstrate a very high 85% overall response rate in patients with metastatic castrate-resistant prostate cancer.

FORT LAUDERDALE, Fla., April 08, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T™, an in situ personalized therapy optimized for solid tumor cancers, today 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%.

James Armitage, M.D., Chairman of Syncromune’s Scientific Advisory Board, former President of ASCO and Joe Shapiro Professor of Medicine at the University of Nebraska Medical Center, commented on the results stating, “This is an innovative and exciting new therapeutic approach that shows promise with encouraging results in treating mCRPC. With minimal toxicity and high response rates in this debilitating cancer, SYNC-T holds significant potential as a viable treatment option for patients with mCRPC. I am incredibly eager to see how it progresses in future clinical trials.”

SYNC-T is a novel and personalized in situ therapy that uses a combination of partial tumor lysis and intratumoral immunotherapy. First, lysis is performed via freezing to disrupt a portion of a target tumor which facilitates the release of cancer-specific signals and activation of the immune system, after which a fixed-dose multi-target drug, SV-102, is directly administered into the tumor site. This is intended to further stimulate the immune system and block mechanisms that suppress the immune response. This combination approach is intended to empower the immune system to recognize and attack patient-specific cancer throughout the body. Injecting SV-102 directly into the tumor enables significantly smaller doses in comparison to those required for systemic IV administration, which may contribute to fewer side effects and lower toxicity than current therapies.

George Prendergast, Ph.D., President and CEO of the Lankenau Institute for Medical Research (LIMR), part of Main Line Health, and former Editor-in-Chief of the AACR’s flagship journal,Cancer Research, added, “This rate of clinical response in mCRPC is unprecedented, given it is a disease with few treatment options, high mortality rates, and for which current treatments have exhibited low response rates and high toxicity. Remarkably, one subject in the trial who enrolled with more than 50 metastatic bone lesions and significantly advanced disease experienced a complete response. This is a profound outcome given the subject’s advanced bone metastases. Based on the clinical data and our observations to date, SYNC-T is emerging as a first-in-class therapy that warrants continued clinical trials.”

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.

These encouraging results support the continued clinical development of the SYNC-T Therapy platform to potentially offer a new treatment option for patients with mCRPC and other solid tumors. The trial’s inclusion in AACR’s press program highlights the interest of the oncology research community in these findings.

For more information about Syncromune and its ongoing clinical trials, please visit www.syncromune.com.

About Syncromune®
Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of an in situ platform technology optimized for metastatic solid tumor cancers that aims to achieve high response rates with potentially improved survival. The company is currently developing SYNC-T, a novel and personalized combination biologic drug/device therapy platform. SYNC-T is designed to synchronize in situ patient-specific antigen T cell activation and immunostimulation via intratumoral infusion, to enable the immune system to recognize and attack cancer throughout the body. The first two candidates, SV-101 and SV-102, are currently in Phase 1 trials. Syncromune is headquartered in Fort Lauderdale, FL, USA. For more information, please visit www.syncromune.com.

About SYNC-T
Syncromune® is developing SYNC-T™, a personalized in situ combination biologic drug/device platform designed to activate T cells and stimulate the immune system to treat metastatic solid tumors. SYNC-T utilizes a combination approach of in situ vaccination via device-induced partial oncolysis and intratumoral infusion of a multi-target biologic drug, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. The therapy is designed to activate the immune system and combat immune suppression, resulting in patient-specific T cell activation. The proliferation of anti-cancer T cells can enable a systemic anti-tumor response, attacking cancer throughout the body.

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
Michael Tattory
LifeSci Communications
mtattory@lifescicomms.com


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