Celiac Disease (CD) is an incurable autoimmune disease of the intestine triggered by ingestion of gluten which can cause debilitating gastrointestinal pain, suffering and potential severe life-long health issues. CD is one of the most common autoimmune diseases and afflicts about 1% of the world’s population. Currently, there are no FDA approved treatments other than following a strict gluten-free diet (GFD), which is nearly impossible to achieve. Gluten (a family of proteins found in wheat, barley and rye) is an ingredient that is used extensively in food manufacturing. Cross-contamination with gluten, even for reputed gluten-free preparations, is difficult to avoid, particularly in a restaurant environment. A recently published study conducted by ImmunogenX and collaborators (American Journal of Clinical Nutrition, 2018) showed that on average, typical CD patients on a GFD often consume hundreds of milligrams of gluten per day, where less than 50 mg per day is generally considered to be a safe level. The US FDA stipulates that products containing less than 20 ppm of gluten may be labeled as gluten-free. Unfortunately, this small amount of gluten is still sufficient to aggravate very sensitive CD patients.
ImmunogenX is a clinical-stage therapeutic and diagnostic company focused on Celiac Disease (CD). Both therapeutic and diagnostic treatments represent unmet needs for this disease and as developers of leading technologies, the company is positioned to be the market leader in the CD space.
ImmunogenX’s lead development is the therapeutic drug Latiglutenase, which has Fast Track status with FDA and has undergone several successful clinical trials through Phase 2b. Latiglutenase is the only therapy in development to have clinically demonstrated histologic protection of the small intestine and symptomatic improvement. Latiglutenase is a mixture of two recombinant digestive enzymes that degrades gluten proteins in the stomach, rendering them non-immunogenic, thus not able to trigger the autoimmune reaction. Latiglutenase is conveniently taken orally with meals to protect against unintended gluten ingestion.
ImmunogenX is also developing a minimally-invasive drug biomarker in-vitro device (IVD), CypCel, as a diagnostic tool for monitoring the intestinal health of diagnosed CD patients. CypCel will be able to assess how well patients are healing on a GFD and used as an alternative to an intrusive and expensive endoscopic biopsy.
Motivations behind the Success of ImmunogenX
The primary co-founder Dr. Jennifer Sealey-Voyksner is the CSO at ImmunogenX. She is a diagnosed CD patient who has dedicated her professional scientific career to bettering the quality of life of CD patients. She specializes in the study of allergenic food proteins using proteomics, and brings varied experience in the pharmaceutical industry and as an entrepreneur, having co-founded and directed a successful analytical laboratory.
Dr. Jack Syage is co-founder and CEO of ImmunogenX. He has had a stellar research career starting in chemical physics and evolving into analytical instrumentation and pharmaceutical research and is a serial entrepreneur whose last venture was acquired by a $20B/year multinational company.
Jennifer oversees the chemistry, manufacturing and control operations for the development of Latiglutenase and CypCel, and manages the analytical activities in the company’s research center. Jack, who handles all aspects of the company’s operations, continues to maintain a strong technical presence, taking a lead role with clinical data analysis and trial design.
“Our success is based on our mission and our firm belief in the demonstrated efficacy and safety of Latiglutenase for the treatment of CD and CypCel for the management of CD and other GI diseases. We further cite Professor Chaitan Khosla of Stanford University, a true visionary and the inventor of both of these technologies, as a motivating figure who also has a family history of CD that has shaped his scientific aspirations,” asserts Jennifer.
Innovative Drugs and Therapies for Histologic Healing from CD
Latiglutenase is a best-in-class therapy on track to be first to market. CypCel is the only drug biomarker diagnostic tool that can monitor the villous health of the small intestine non-intrusively.
ImmunogenX has strong patent protection covering any emerging competing therapy based on enzyme treatment. Latiglutenase is protected by over 50 U.S. and foreign patents issued or pending around 13 patent families with expirations ranging from 2025 to 2038. CypCel has a smaller, but broad and long-term patent portfolio.
Distinctive Approach to Innovations
“We are a uniquely qualified company that understands the market. We have the requisite business and technical acumen, we are passionate about the societal benefits we can offer to the celiac community, and have the relationships and connections to partner with financial and strategic partners to execute on the entire regulatory and commercial roadmap,” says Jack.
Developing Latiglutenase and CypCel addresses unmet needs in the market for which there are no predicates.. This requires a unique approach on the clinical and regulatory pathways. “We are very fortunate that the Division of Gastroenterology of the FDA clearly understands the needs of the CD patient,” says team ImmunogenX.
ImmunogenX has been successfully raising the capital required to achieve the significant progress to date and is confident of completing the funding required to conduct the next Phase 2/3 clinical trial that will then position ImmunogenX for a final Phase 3 registration trial for the therapeutic Latiglutenase and the pivotal in-vitro device trial for CypCel.