Later this month in Philadelphia at the BIO International Convention, BIO will be partnering with the National Institutes of Health (NIH) and the National Science Foundation (NSF) to host the 2nd annual, newly-expanded BIO Innovation Zone. The Zone will feature Small Business Innovation Research (SBIR) funded early-stage biotech companies.
The SBIR/STTR program provides U.S. federal funding to small businesses engaged in research with the potential for commercialization. Each of the companies has been rigorously vetted through the SBIR/STTR review process prior to receiving the non-dilutive funding to engage in R&D that has the potential for commercialization. The NIH and NSF invest a combined $940 million annually in the programs.
Today, we spoke with Justin Savage, the Director of Operations at GlycoMira Therapeutics based in Salt Lake City, Utah, Weng-Lang Yang, the Chief Scientific Officer of TheraSource LLC in Manhasset, New York and George Falus, CEO of Biomedica Management. These three biotechnology companies have been supported by the NIH’s SBIR program.
What is your company’s lead product or technology?
Justin Savage, GlycoMira Therapeutics, Inc: GlycoMira is developing the next generation of therapies to prevent and treat oral inflammatory diseases that plague half of all Americans. Our specific focus includes periodontal disease, a common inflammatory disorder of the gingival tissues and bone for which there have been no new drugs developed in over a decade. Broadening to the oral cavity as well as the sinonasal cavity, the same therapies can alleviate oral mucositis and rhinosinusitis. Oral mucositis is a common complication of cancer radiation therapy for which no effective treatments exist. GlycoMira has developed GM-0111, a synthetic polysaccharide which has demonstrated utility in disease models to effectively and safely prevent inflammation. GM-0111 coats mucosal tissues, and blocks multiple factors involved in inflammation, promising to be an effective therapeutic for oral and sinonasal inflammatory disease.
Weng-Lang Yang, TheraSource LLC: rhMFG-E8, a recombinant protein as a novel therapeutic for acute kidney injury (AKI).
George Falus, Biomedica Management: Next generation fibrin hemostatic sealants developed under a proprietary new platform technology produces safer, purer, stronger hemostats. These agents do not contain thrombin, are stored at room temperature, final sterilized, and are indicted to wide range of applications, including severe trauma and emergency medicine. It is paradigm shift that meets evolving standards of care.
How has the NIH SBIR program helped your company grow?
Justin Savage, GlycoMira Therapeutics, Inc: The NIH SBIR program has been critical to the continued development of this promising therapeutic innovation for oral and sinonasal biology and pathology. We are committed to improving the lives of people through focused efforts in translational medicine, and we will stay focused on getting this new technology from the bench to the mouths and noses of people in need of treatment.
Weng-Lang Yang,TheraSource LLC: The NIH SBIR program provides a direct support for the operation and pre-clinical development of our drug candidate. We also participate in the NIH Commercialization Assistance Program (CAP) to sharpen our strategic planning to advance our drug to the clinical stage.
George Falus, Biomedica Management: NHLBI has funded this technology since it conception through IND submission and phase I clinical trials.
What are the upcoming milestones and long-term priorities for your company?
Justin Savage, GlycoMira Therapeutics, Inc: Our milestones reflect those of many biotech startups: (1) validate the efficacy and safety of cGMP materials in accepted models, (2) raise funds from non-dilutive and investors to fund the pilot manufacturing and toxicology studies, and (3) obtain FDA guidance and ultimately approval for the target formulations for oral and sinonasal care. In the long term, we seek strategic partnerships to bring each formulation to the targeted patient populations.
Weng-Lang Yang,TheraSource LLC: Manufacturing of GLP/cGMP grade of rhMFG-E8 and filing of an IND application for Phase I/II clinical trials.
George Falus, Biomedica Management: The Joint Warfigter Medical Research Program of USMRAA is suporting phase II of ClotFoam, a formulation for severe bleeding in traumatic injuries. A private investment effort is underway to complete phase II of the two commerical room temperature formulations ClotGel and ClotSpray.
What do you hope to gain out of your participation at the 2015 BIO International Convention?
Justin Savage, GlycoMira Therapeutics, Inc: GlycoMira is seeking a strategic partner and investment to advance the technology and to be able to effectively take the validated formulations to the market.
Weng-Lang Yang, TheraSource LLC: Identifying the CRO for rhMFG-E8 manufacturing, partnering with a pharma to co-develop rhMFG-E8 for treating AKI.
George Falus, Biomedica Management: We hope reach and inform the biotechnology industry and investment group of the advantages of this ground-breaking technology that leaves behind fibrin-based hemostatic sealants that no longer meet today’s standards of care.
Tell us something about your company that investors might not know.
Justin Savage, GlycoMira Therapeutics, Inc: GlycoMira has successfully raised over $3.25 million in funding including seven SBIR awards from the National Institutes of Health, State of Utah commercialization funds, and private investors.
Weng-Lang Yang, TheraSource LLC: TheraSource has an excellent R&D team for drug development with a strong IP portfolio
George Falus, Biomedica Management: The company began this development in a collaborative effort with leading academic scientists in the field of fibrinogen chemistry in partnership with trauma surgeons. Biomedica has been funded by non-diluting funds provided by NHLBI, USMRMC, University of Maryland and the Technology Development Corporation of Maryland. Less than 5% of funds used for development are from private investment. However, as the company enters in phase II clinical trials, we expect to raise development funds from private investors and from potential strategic partners.