Syncromune Granted FDA Fast-Track Designation for SYNC-T SV-102 for the Treatment of Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
01 July 2024 - 1:00PM
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 profile and 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 www.syncromune.com.
About SYNC-TSyncromune® 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 ContactDanielle HobbsEVP, Corporate
CommunicationsSyncromune, Inc.media@syncromune.com
Media ContactMichael TattoryLifeSci
Communicationsmtattory@lifescicomms.com