Celimmune Founded to Develop Novel Therapeutics for Celiac and Other Serious Autoimmune Diseases

LEBANON, N.J. and BETHESDA, Md., Feb. 23, 2015 /PRNewswire/ -- Celimmune LLC, a clinical development-stage immunotherapy company targeting autoimmunity and inflammation, today announced that it will initially focus its distinctive core competence in translational medicine, immunotherapy clinical development and commercialization on combating celiac disease.

Experienced industry executives, Dr. Francisco Leon and Mr. Ashleigh Palmer, have cofounded Celimmune with a strategic intent to acquire, develop and commercialize innovative therapeutics to treat and prevent immune disorders. Celimmune's initial efforts will focus on diet non-responsive celiac disease and refractory celiac disease (celiac disease-triggered T-cell lymphoma).

Mr. Palmer, Celimmune's Executive Chairman, stated, "Initially, in cofounding and financing Celimmune, we will be targeting a unique underserved and grossly underappreciated medical and socioeconomic need representing a substantial commercial opportunity. Despite well-characterized pathophysiology and well-understood science, only a handful of clinical-stage assets are in active development worldwide for celiac disease and it is with this in mind that Celimmune is committed to acquiring and in-licensing carefully screened and selected therapeutic candidates for rapid translation into advanced-stage clinical development."

Dr. Leon, Celimmune's CEO and Chief Medical Officer, explained, "Currently, there are no treatments approved for celiac disease and the only management option is a strict, life-long, gluten-free diet, which severely impacts quality of life and presents considerable compliance challenges. Gluten contamination is pervasive in modern society and celiac patients' perception of the burden of this disease on their lives is second only to chronic end-stage renal disease.  A normal daily diet contains more than 10 grams of gluten, the main protein in common cereals such as wheat, barley and rye, but as little gluten as 50 milligrams per day can trigger active disease in patients. As much as 50% of celiac subjects on a disciplined gluten-free diet still exhibit active disease (non-responsive celiac disease), as evidenced by complete mucosal atrophy, circulating autoantibodies and clinical symptoms. Celiac autoantibodies are believed to be responsible for many of the multiple extra-intestinal manifestations of celiac disease, including dermatitis and neurological disorders. A rare and life-threatening complication of celiac disease is Refractory Celiac Disease (RCD), occurring in about 1% of celiac patients. RCD is a T cell lymphoma with very poor prognosis and no approved therapy."

Dr. Leon joins Celimmune from Johnson & Johnson's Janssen Pharmaceuticals, formerly Centocor, where he was Vice President and Head of Translational Medicine and led the company's early-stage clinical development in immunology. Dr. Leon is also an Adjunct Research Associate Professor of Medicine at Jefferson Medical College (Philadelphia), where he contributes to the clinical research efforts of the Department of Gastroenterology.

Prior to joining Janssen in 2010, Dr. Leon had devoted most of his industry and academic career to the fields of autoimmunity and celiac disease, including as Chief Medical Officer at Alba Therapeutics and various positions in clinical research at Bristol Myers-Squibb and MedImmune/Astra Zeneca. Dr. Leon is a trained translational immunologist who received his MD and PhD from Autónoma University in Madrid, Spain, prior to becoming a Research Fellow at the National Institutes for Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), before joining the biopharma industry. In his 20 years of experience in translational immunology, Dr. Leon has authored or co-authored more than 70 peer-reviewed articles, book chapters and patents.

In addition to his Executive Chairman's duties with Celimmune, Mr. Palmer will continue as President of Creative BioVentures™ Corp. (CBV), a strategic advisory firm serving the biopharma industry.  Since founding CBV in 2002, Mr. Palmer has advised numerous clients regarding corporate positioning and strategy, fund raising, M&A transactions, clinical development and commercialization, and has undertaken a number of CEO and board level transformational leadership and turnaround assignments for both public and private biopharma companies.

Prior to founding CBV, Mr. Palmer was Vice President, Business Development for British Oxygen's Ohmeda, Inc., where he was instrumental in its $1.2 billion sale to a Baxter-led consortium by spinning out the company's inhaled nitric oxide assets as INO Therapeutics, Inc.  Under his leadership, as founding President and CEO, INO Therapeutics (now Ikaria) developed and commercialized the world's first selective pulmonary vasodilator, INOmax^®, establishing a time-based pricing, orphan drug franchise, subsequently acquired for $1.6 billion by Madison Dearborn. Earlier in his career, Mr. Palmer held positions of increasing responsibility in sales and marketing management at Reckitt Benckiser. Educated in the UK, Mr. Palmer received his MBA from the University of Bradford and his BSc. honors in Biochemistry and Applied Molecular Biology from the University of Manchester.

About Celiac Disease
Celiac disease is a chronic hereditary systemic autoimmune and inflammatory disease triggered by gluten consumption. Celiac disease is characterized by damage to the lining of the small intestine, causing gastrointestinal dysfunction and debilitating symptoms. Nutritional malabsorption can lead to a failure to thrive in children and anemia and osteopenia in adults. Over the course of a life time, untreated or poorly managed celiac disease is often associated with deteriorating general health, multiple serious intestinal and extra-intestinal medical complications, and increased morbidity and mortality. Currently 1% of Western and 0.5% of Asian populations suffer from celiac disease and diagnosed prevalence is expected to increase dramatically with improved diagnostic tools and clinical awareness.

About Celimmune
Celimmune LLC, a clinical development-stage immunotherapy company focused on treating and preventing autoimmunity, began operating in February 2015 and is headquartered in Bethesda, Maryland. Celimmune will initially focus its distinctive core competence in translational medicine, immunotherapy clinical development and commercialization on combating celiac disease and other serious autoimmune diseases.

SOURCE Celimmune LLC