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SBIR-STTR-Tibbetts Award Winner - ImmunogenX, LLC

Company Name:
Post Date:
September 07, 2021
Company Location:
Newport Beach, CA
United States

2020 Tibbetts Award Winner

ImmunogenX, LLC is pioneering eforts in Celiac disease therapy, management, and food safety.                                                                                                                                                                



Newport Beach







Department of Defense


Department of Health and Human Services


Department of Commerce – National Institute of Standards and Technology


National Science Foundation

Impact & Achievement

What if better diagnostics and treatment were available to the ever-growing population affected by celiac disease? This is the question ImmunogenX, a clinical-stage biotherapeutics company, seeks to answer through clinical trials for its therapeutic drug and diagnostic technology for celiac disease, with funding from the Small Business Innovation (SBIR) Program. While many entrepreneurs dream of creating a thriving and innovative business, the talent behind ImmunogenX has done so twice! Dr. Jack Syage has achieved remarkable success in both his scientific and entrepreneurial careers – having founded Syagen Technology in 1997 and ImmunogenX (a subsidiary of Immunogenics LLC) in 2013. The outcome of these projects has not only led to significant advancements in the field of mass spectrometry and clinical trials, but also more than $100 million in commercial revenue and over $50 million in non-SBIR government and commercial contracts, licensing, investments, and acquisitions.


Celiac disease is a serious genetic autoimmune disease that damages the villi of the small intestine and interferes with absorption of nutrients from food. Unfortunately, for the Americans affected by celiac disease - there are no pharmaceutical treatments or cures, and a 100% gluten-free diet is the only treatment available today. Further, an estimated of Americans who have celiac disease are undiagnosed or misdiagnosed with other conditions. ImmunogenX is bridging that gap through its pioneering efforts in celiac disease therapy, management, and food safety.


The term 'biotherapeutics' refers to any type of treatment that is produced by or involves living cells. ImmunogenX is developing Latiglutenase for celiac disease therapy, as well as CypCel™ - a minimally-invasive diagnostic tool for celiac disease management. CypCel™ is based on a clinically relevant metabolic marker compound that can assess the state of recovery of a celiac patient adhering to a gluten-free diet or other treatment. For food safety, ImmunogenX is pioneering advanced mass spectrometry methods to identify and measure physiologically relevant gluten peptide sequences found in wheat, barley, and rye.


Dr. Syage of ImmunogenX is a strong proponent of the SBIR program, even recognized in the community as an SBIR “ambassador,” and is no stranger to SBIR Phase III success - having also achieved it before with Syagen Technology, Inc. Together, Syagen and ImmunogenX have seen more than $117M in Phase III investments amid strong commercial successes. SBIR program funding from the National Institutes of Health (NIH), National Science Foundation (NSF), and Department of Defense (DoD) have all contributed immensely to the development and commercialization of a number of technologies as well as clinical trials. ImmunogenX has now successfully applied SBIR funding from the NIH to conduct Phase 2 clinical trials for a therapeutic drug and diagnostic technology for celiac disease.


ImmunogenX is supported by a team of world-renowned clinicians, scientists and advisors in celiac disease research, and is successfully running clinical trials in collaboration with Mayo Clinic, Columbia University, and Stanford University. ImmunogenX’s high success rate in winning SBIR grants and strong record of commercialization continue to represent an excellent return on investment for the SBIR program, and a hopeful future for those affected by celiac disease.

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