SV-102

FORT LAUDERDALE, Fla., July 01, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for solid tumor cancers, 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). SV-102 is part of Syncromune Inc.'s innovative SYNC-T platform, an in situ personalized therapy that uniquely employs a combination multi-target approach to cancer treatment, aiming to improve outcomes and quality of life for patients. 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. This advanced form of prostate cancer affects over 40,000 men in the U.S. alone and is associated with a very poor prognosis. The Fast Track process is designed to facilitate the development and expedite the review of therapies that treat serious conditions and fulfill an unmet medical need, with the goal of getting important new treatments to patients sooner. Fast Track designation provides Syncromune with several key benefits, including more frequent FDA interactions, eligibility for accelerated approval, and priority review. “The Fast-Track designation for SYNC-T SV-102 therapy signifies another step forward in bringing our potentially groundbreaking therapy to patients who need it most,” said Eamonn Hobbs, Chief Executive Officer and co-founder of Syncromune. “This accomplishment builds upon the foundation of positive Phase 1 clinical data and recent IND clearance.” Syncromune’s lead candidate, SYNC-T SV-102, is a platform therapy that combines an in situ vaccine via partial oncolysis of a tumor followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor. This combination is designed to provide both immune stimulation and block immune suppression to activate and proliferate T cells to elicit a systemic anti-tumor response. 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 pro tolerability. The Fast-Track designation comes on the heels of clearance of the company’s investigational new drug (IND) application, with studies expected to begin in the US this year. Charles Link, M.D., Executive Chairman of Syncromune added, “We believe that Fast-Track designation for SYNC-T SV-102 will significantly aid our development goals for this therapy for men with difficult to treat prostate cancer. 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.” 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 multi-target biologic drug/device therapy platform. SYNC-T is designed to synchronize in situ patient-specific antigen T cell activation 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 . About SYNC-T Syncromune® is developing SYNC-T, a personalized in situ combination multi-target 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 tumor 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

SYNC-T SV-102 Therapy combines partial tumor oncolysis with a fixed-dose combination multi-target biologic drug to provide a novel, personalized therapeutic approach for the treatment of 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 FORT LAUDERDALE, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Syncromune® Inc., a clinical-stage biopharmaceutical company focused on the development of SYNC-T, an in situ personalized therapy platform optimized for solid tumor cancers, today 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. "Receiving clearance of our IND is a significant milestone for Syncromune and will allow us to rapidly advance the clinical development of SYNC-T SV-102," said Syncromune’s President and CEO, Eamonn Hobbs. "This clearance, following our recent presentation at AACR of data demonstrating unprecedented response rates, underscores the potential of SYNC-T SV-102 to change the landscape of prostate cancer treatment." "We are thrilled to obtain clearance to advance the SYNC-T SV-102 Therapy and the company is well-positioned to achieve key program milestones,” added Charles Link, M.D., Syncromune’s Executive Chairman. "The prospects of this new combination multi-target approach and its broad potential applicability in the treatment of metastatic solid tumor cancers is incredibly exciting." The SYNC-T platform is a novel and personalized in situ therapy that uses a unique combination approach of partial tumor oncolysis and a multi-target biologic drug comprised of four active pharmaceutical ingredients (APIs). First, oncolysis is performed via freezing to disrupt a portion of a target tumor which facilitates the release of cancer-specific signals and tumor antigens, activating the immune system and creating an in situ vaccine. Next, a fixed-dose combination multi-target biologic drug, SV-102, is directly infused into the tumor site. This is intended to further stimulate the immune system and block mechanisms that suppress the immune response. The combination approach is designed to promote T cell activation and proliferation, empowering the immune system to recognize and attack patient-specific cancer throughout the body. In a Phase 1 trial conducted in metastatic castrate-resistant prostate cancer patients, SYNC-T SV-102 demonstrated an objective response rate (ORR) of 85% with five complete responses (CRs) and six partial responses (PRs) among the 13 evaluable subjects. Notably, 54% of the subjects demonstrated complete resolution of their bone metastases. The treatment was well tolerated, with a favorable side effect pro no significant safety concerns. For more information about Syncromune and its ongoing clinical trials, please visit . 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 . 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