Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2
24 1월 2024 - 11:15PM
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company
developing transformative cell and exosome-based therapeutics for
the treatment and prevention of rare diseases, today announced that
Capricor’s proprietary StealthX™ exosome-based multivalent vaccine
(StealthX™ vaccine) for the prevention of SARS-CoV-2 has been
selected to be part of Project NextGen, an initiative by
the U.S. Department of Health and Human Services to
advance a pipeline of new, innovative vaccines providing broader
and more durable protection for COVID-19. As part of Project
NextGen, the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health, will conduct a
Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject
to regulatory approval. NIAID's Division of Microbiology and
Infectious Diseases (DMID) would oversee the study.
“We are extremely pleased with the external
support from the NIH, which highlights the clinical potential of
our StealthX™ exosome platform technology and provides non-dilutive
support for the advancement of our vaccine candidate,” said Linda
Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary
vaccine is multivalent, delivering both the highly mutagenic S
protein (Spike) and the more stable N protein (Nucleocapsid) which
potentially may offer broader and longer lasting immunity against
SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first
clinical step towards development of a next generation vaccine
platform that may be extended to other infectious diseases. Our
platform is designed to combine the speed of response of an mRNA
vaccine with the potential efficacy of a protein vaccine. Further,
our StealthX™ vaccine is free of both adjuvant and lipid
nanoparticles and in preclinical studies has generated a strong
immune response at low doses. We believe our StealthX™ vaccine may
offer a clinically meaningful alternative for highly mutating or
novel infectious agents.”
Dr. Marbán continued, “This is the opportunity
we have been waiting for as it allows the exosome technology to be
brought into the clinic as we continue to focus our resources on
CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond
SARS-CoV-2, we look forward to exploring the potential therapeutic
utility of this platform, and more broadly, expanding our pipeline
into therapeutics and future partnership opportunities.”
About Capricor’s StealthX™
Vaccine
The StealthX™ vaccine is a proprietary vaccine
developed internally by Capricor utilizing exosomes that were
engineered to express either spike or nucleocapsid proteins on the
surface. Preclinical results from murine and rabbit models
published in Microbiology Spectrum, showed the StealthX™
vaccine, resulted in robust antibody production, potent
neutralizing antibodies, a strong T-cell response and a favorable
safety profile. These effects were obtained with
administration of only nanogram amounts of protein and without
adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a
new antigen delivery system that potentially could be utilized to
rapidly generate multivalent protein-based vaccines. Exosomes,
first identified as extracellular vesicles, are small vesicles
enriched in specific subsets of proteins, RNAs and lipids and
responsible for cell-to-cell communication.
About Capricor Therapeutics
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a
biotechnology company focused on the development of transformative
cell and exosome-based therapeutics for the treatment and
prevention of rare diseases. Capricor’s lead candidate, CAP-1002,
is an allogeneic cardiac-derived cell therapy currently in Phase 3
clinical development for treating Duchenne muscular dystrophy
(DMD). Further, Capricor has entered into
a partnership for the exclusive commercialization and
distribution of CAP-1002 for DMD in the United States and Japan
with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma,
Inc.), subject to regulatory approval. Capricor is also developing
its exosome technology as a potential next-generation therapeutic
platform. Our proprietary StealthX™ exosome platform has potential
for a broad range of new therapeutic applications in the field of
vaccinology as well as targeted oligonucleotide, protein and small
molecule therapeutics to treat or prevent a variety of diseases.
For more information, visit capricor.com, and follow Capricor
on Facebook, Instagram and Twitter.
Cautionary Note Regarding
Forward-Looking Statements
Statements in this press release regarding the
efficacy, safety, and intended utilization of Capricor’s product
candidates; the initiation, conduct, size, timing and results of
discovery efforts and clinical trials; the pace of enrollment of
clinical trials; plans regarding regulatory filings, future
research and clinical trials; regulatory developments involving
products, including the ability to obtain regulatory approvals or
otherwise bring products to market; manufacturing capabilities; the
ability to achieve product milestones and to receive milestone
payments from commercial partners; plans regarding current and
future collaborative activities and the ownership of commercial
rights; scope, duration, validity and enforceability of
intellectual property rights; future royalty streams and revenue
projections; expectations with respect to the expected use of
proceeds from the recently completed offerings and the anticipated
effects of the offerings; and any other statements about Capricor’s
management team’s future expectations, beliefs, goals, plans or
prospects constitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Any
statements that are not statements of historical fact (including
statements containing the words “believes,” “plans,” “could,”
“anticipates,” “expects,” “estimates,” “should,” “target,” “will,”
“would” and similar expressions) should also be considered to be
forward-looking statements. There are a number of important factors
that could cause actual results or events to differ materially from
those indicated by such forward-looking statements. More
information about these and other risks that may impact Capricor’s
business is set forth in Capricor’s Annual Report on Form 10-K for
the year ended December 31, 2022, as filed with the Securities and
Exchange Commission on March 17, 2023 and in our Quarterly Report
on Form 10-Q for the quarter ended September 30, 2023, as filed
with the Securities and Exchange Commission on November 14, 2023.
All forward-looking statements in this press release are based on
information available to Capricor as of the date hereof, and
Capricor assumes no obligation to update these forward-looking
statements.
CAP-1002 is an Investigational New Drug and is
not approved for any indications. None of Capricor’s exosome-based
candidates have been approved for clinical investigation.
For more information, please
contact:
Capricor Company Contact:AJ
Bergmann, Chief Financial Officerabergmann@capricor.com
858.727.1755
Capricor Therapeutics (NASDAQ:CAPR)
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