Top Five Stem Cell Companies to Watch in the BioHealth Capital Region 

April 16, 2019

The BioHealth Capital Region (BHCR) is rapidly becoming an industry hub for companies that are developing next-generation therapeutics that focus on personalized and regenerative medicine for the treatment and potential cure of unmet medical needs. Autolus, Inc., a CAR T-cell therapy company, and REGENXBIO, a gene therapy company focused therapies for rare diseases, are two examples of emerging leaders in the personalized medicine field making their imprint on the region.

A host of other BHCR companies are focused on regenerative medicine and are developing a range of cutting edge stem cell therapies. An important reason why Maryland has become a world leader in stem cell therapeutics is due to the Maryland Stem Cell Research Fund (MSCRF), which was first established in 2006.  Since then the state-backed program has funded 436 awards with $148 million in stem cell research grants that have helped to catalyze the growth of this industry in Maryland. MSCRF is now accepting new applications through Jully 11th for their five funding programs.

Let’s take a look at the five stem cell companies to watch in the BHCR.

Gemstone Therapeutics

Gemstone Therapeutics, located in Baltimore, MD and founded in 2013, is a privately held, pre-clinical research and development company established with in-licensed technology from Johns Hopkins University and seed capital provided by local angel investment group Gamma3. Its lead pipeline product is moving toward FDA IND submission in early 2019 and is based upon materials technology invented by Johns Hopkins’ Dr. Sharon Gerecht, who remains a key adviser to the Gemstone team. Gemstone is focused on revolutionizing wound care with a novel biosynthetic material that has the potential to offer patients what CEO Dr. Emily English calls, “healing plus.”

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A signal of its company-to-watch status, English and Gemstone recently received a commercialization award of approximately $300,000 from the Maryland Stem Cell Research Fund.  The organization plans to use the stem cell award to enhance its pipeline by customizing the core material to achieve better efficacy for severe burns.

Theradaptive, Inc.

Theradaptive, Inc., located in Frederick, MD and founded in 2014, is a privately held biotechnology company focused on regenerative medicine. It is currently developing a therapeutic platform that promotes targeted native tissue repair. The platform’s indications include spinal fusion, trauma repair, dental repair, and complex cartilage repair (Source: Theradaptive). The company is a Massachusetts Institute of Technology (MIT) spin out that “is based on a proprietary ceramic-binding technology that allows for the targeted delivery of any therapeutic protein on the surface of implants or as depot formulations….The platform can also be used to deliver any biologic on the surface of implantable or injectable ceramic carriers.”

The company’s founder, MIT alumnus and Iraqi war veteran Luis Alvarez, was inspired to develop tissue regeneration therapies that could help repair devastating injuries after experiencing an IED blast in 2004.

Most recently, Theradaptive was the sole recipient of the 2018 Maryland Stem Cell Research Fund Commercialization Grant and was named a finalist for the 2018 First Coast Innovation Challenge held in Boston, MA The company also received phase II funding under the Defense Health Program Small Business Innovation Initiative Research Program and has a partnership on a $1.47M DoD contract to develop next-generation 3D printed drug eluting spinal fusion devices (Source: Theradaptive).

Propagenix Inc.

Propagenix Inc. (“Engineering personalized solutions for epithelial tissue disease”) is a Rockville, MD-based cell therapy platform technology company providing engineered tissue solutions to address clinical needs in replacing a patient’s own dysfunctional or damaged barrier tissues.

The company’s technology is based on the ability to massively expand and differentiate tissue-resident epithelial stem cells. Applications of this platform technology is directed at meeting the challenge of manufacturing safe, clinical-scale amounts of biologically functional epithelial cells obtained from individual patients. This deliverable is essential for both transplantation of skin, airway, and corneal lining cells as well as in diagnostic applications in oncology and airway disease. The company’s IP is secured with nine issued patents (eight U.S., one Japan) and multiple additional patents forthcoming.

Maryland Stem Cell Research Commission Announces Funding Opportunities

Propagenix’s partners are biopharmaceutical, medical device, life science, and consumer product firms that access company technology via product sales, licensing, and collaborative research agreements. The company has attracted over ten major biopharmaceutical and life sciences firms as clients, including therapeutic-focused deals to access Propagenix technology. (Source: MSCRF)

Neuralstem, Inc.

Neuralstem, Inc. is located in Germantown, MD and was founded in 1999. The publicly traded (NASDAQ: CUR) clinical-stage biopharmaceutical company is focused on the research and development of novel nervous system disease treatments using small molecules, stem cell technology and a new chemical screening entity. Neuralstem’s lead stem cell therapy candidate, NSI-566, is in phase II trials in the U.S. for Amyotrophic Lateral Sclerosis, phase I in the U.S. for chronic spinal cord injury and phase I in China for Ischemic Stroke.

The organization’s “…proprietary methodology enables the generation and commercial-scale production of regionally specific neural stem cell lines for use in therapeutic indications or drug screening.”  (Neuralstem) In February 2019 the company announced a new strategic approach to expand its pipeline following the appointment of biopharmaceutical veteran Kenneth C. Carter, PhD, as Executive Chairman. The company’s lead pipeline asset is the small molecule entity NSI-189, which is in phase II clinical trials for Major Depressive Disorder (MDD); it is also in the preclinical stage for several other indications, including Angelman Syndrome, cognitive impairment, Type 1 and 2 diabetes and stroke.  

Seraxis, Inc.

Seraxis, Inc., located at the Germantown Innovation Center in Germantown, MD and founded in 2013, is a regenerative medicine biotech company. Led by CEO Dr. William L. Rust and CBO Dr. Carole A. Welsch, Seraxis has successfully developed leading-edge stem cell-derived replacement therapy for the treatment of insulin-dependent diabetes. The stem cell-derived therapy SR-01 is able to “… normalize blood glucose over a long term in animal models of diabetes and will soon be tested in the clinic.” (TEDCO).

The company’s mission is to bring practical cell therapy for insulin-dependent diabetes to clinical trials, with the ultimate goal being to provide a long-term cure that does not require immunosuppression. SR-01 has the potential to provide type-1 diabetics with long term blood glucose regulation without dependence on insulin injections. The implanted device is designed to release insulin and/or glucagon in response to blood glucose variations, providing blood glucose control levels similar to a non-diabetic adult. Seraxis has received significant grant support from TEDCO and is on the verge of clinical testing, making it a stem cell company to watch closely in 2019 and beyond.

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