Capricor and USAISR Announce Collaboration to Investigate Exosome Platform to Treat Injured Troops

LOS ANGELES, July 17, 2018 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR) today announced it has entered into an agreement with the U.S. Army Institute of Surgical Research (USAISR) to study the potential for the company’s next-generation investigational therapeutic platform, designated CAP-2003, which represents extracelluar vesicles (e.g., exosomes and microvesicles) to address a wide spectrum of trauma-related injuries and conditions, which are now the third leading cause of death in the U.S.

CAP-2003 is derived from Capricor’s proprietary cardiosphere-derived cells (CDCs), which comprise adult cardiac progenitor cells from donor heart tissue.  CAP-2003 has shown promising results in various pre-clinical experiments using established animal models of diseases by exerting anti-inflammatory, anti-fibrotic, pro-angiogenic, and anti-apoptotic effects.

“In developing CAP-2003, Capricor has distilled the active pharmaceutical ingredient (API) of the cells and created a therapeutic that may be easier to use than cell-based therapeutics,” said Linda Marbán, Ph.D., Capricor president and CEO. “CAP-2003 doesn’t require refrigeration or special handling, potentially making it well suited for treating and stabilizing injured soldiers in the field, potentially improving their chances of surviving until they can be transported and receive treatment at medical facilities.”

USAISR entered into the collaboration with Capricor after determining cell-free therapies offer great promise for treating conditions that contribute to soldier morbidity and mortality. Capricor will provide CAP-2003 for testing of function, potency and safety for eventual use in therapeutic indications. Because this is potentially a very important clinical use of CAP-2003, Capricor will work closely with USAISR on its studies and in publishing results of those studies in peer-reviewed journals.

“We were very pleased to enter into this collaboration with Capricor and look forward to studying the utility and delivery of exosomes for trauma-related injuries that soldiers experience on the battlefield,” said James Bynum, Ph.D., USAISR principal investigator. “One of the goals of this collaboration is to test whether CAP-2003 will provide a useful tool on the battlefield to stabilize injured soldiers while they wait for transport to a medical facility. If we can achieve this goal, we will be able to potentially make a meaningful difference in the preservation of life. One of the reasons exosomes are so exciting as a potential therapeutic is their stability, which may allow them to be carried in a medic’s pack and deployed immediately. This is in contrast to earlier cell-based therapies where the necessity of a frozen product prevented easy access. This could be the beginning of a completely new therapeutic paradigm in stabilizing injured warriors.”

The exosomes produced by the CDCs are quantitatively different in terms of contents compared to mesenchymal stem cells (MSC) and other types of exosomes. Preclinical studies suggest that CAP-2003 might lead to different and perhaps augmented clinical benefit when directly compared to other types of exosomes.

“This collaboration will provide the much-needed standardization of extracellular vesicle production, usage and identification for this rapidly growing field, further positioning us as one of the leaders in the development of therapeutic exosomes,” said Dr. Marbán. “This endeavor stands to open up a new arena in biotechnology, where the benefits of cells can be distilled down to the API now known to be extracellular vesicles. Our work with USAISR is also important for the further development of our CAP-2003 technology because if it proves to be promising, we will work on developing large-scale manufacturing as well as clinical development as a result of it.”

About CAP-2003
CAP-2003 is being developed as a next-generation therapeutic platform in regenerative medicine. CAP-2003 is comprised of nano-sized extracellular vesicles, including exosomes and microvesicles, which exert anti-inflammatory, pro-angiogenic, anti-apoptotic, and anti-fibrotic effects. CAP-2003 contains several characteristic lipids, proteins, and RNA molecules (e.g., microRNAs). They act as messengers to regulate the functions of neighboring cells. Pre-clinical research has shown that exogenously-administered extracellular vesicles can direct or, in some cases, re-direct cellular activity, supporting their therapeutic potential. Their size, ease of crossing cell membranes and ability to communicate in native cellular language make them an exciting class of potential therapeutic agents.

About Capricor Therapeutics

Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class biological therapeutics for the treatment of rare disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy. Capricor has also established itself as one of the leading companies investigating the field of extracellular vesicles and is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, please visit www.capricor.com.

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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; 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, 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, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with the prospectus included therein and prospectus supplements thereto and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on May 14, 2018. 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. CAP-2003 has not yet been approved for clinical investigation.

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