NImmune Biopharma Announces Publication on the Safety, Efficacy and Novel LANCL2 Mechanism of Action of Omilancor in Inflammatory Bowel Diseases

by | Nov 2, 2023

This publication describes novel LANCL2-based immunoregulatory mechanisms that enhance regulatory T cells (Tregs) anti-inflammatory functions by amplifying IL-2 signaling and promote T cell metabolic reprogramming resulting in enhanced mitochondrial metabolism

Once-a-day oral dosing with omilancor induced clinical remission in 30.4% of active Ulcerative Colitis (UC) patients versus 3.7% in the placebo group (Δ=26.7%, P = 0.01)

These new insights on LANCL2 immunometabolic mechanisms and positive clinical findings support the development of LANCL2 therapeutics such as omilancor for the treatment of UC, CD, psoriasis, and other autoimmune diseases

Blacksburg VA, November 2, 2023NImmune Biopharma, (“NImmune”), a private late-clinical-stage precision immunology biopharmaceutical company focused on the discovery and development of best-in-class biomarker-driven immunoregulatory therapeutics, led by omilancor, a Phase 3 best in class once daily oral therapy for Ulcerative Colitis, today announced the publication of an article that describes a novel LANCL2-based immunoregulatory mechanism and demonstrates the efficacy of omilancor, a first-in-class, oral, once-daily, LANCL2-activating therapeutic candidate for patients with autoimmune diseases, with an initial focus on ulcerative colitis and Crohn’s disease. These novel mechanistic insights, clinical, and translational findings were published in a recent publication in Inflammatory Bowel Diseases (IBD Journal”).

“By outlining the novel immunoregulatory mechanisms mediated by LANCL2 activation in the gut mucosa leading to immune tolerance, this publication unveils the first-in-class efficacy and safety of oral omilancor in treating Ulcerative Colitis and Crohn’s disease,” said Dr. Josep Bassaganya-Riera, Founder, President, and CEO of NImmune and corresponding author of the study. “New mechanistic insights demonstrate how activation of LANCL2 by omilancor reduces mucosal inflammation and effector responses while enhancing regulatory responses in IBD. The clinical validation of the LANCL2 pathway postulates omilancor and other LANCL2 therapeutics as promising therapeutic modalities to intercept the pathogenesis of IBD and other autoimmune diseases and induce therapeutic efficacy by facilitating the production of fully functional Tregs, down-regulating excessive or dysregulated effector responses and generating long-lasting immune tolerance.”

“This recognition of a novel immunometabolic mechanism of action for treating UC and CD in IBD Journal is a testament to our advanced computational capabilities for drug development exemplified by our TITAN-X Platform, experienced research team, and the positive clinical results that our clinical trials have produced with regard to our expansible LANCL2 therapeutic portfolio,” continued Dr. Bassaganya-Riera. “Following publication of positive clinical results in UC and CD, and the FDA approval of our Phase 3 program for UC, we remain steadfast in our mission to develop safer and more effective therapeutics that address the unmet clinical needs of IBD patients in the U.S. and worldwide.”

This review outlines a new treatment modality for autoimmune and inflammatory diseases based on the pharmacological activation of the LANCL2 pathway, a new immunometabolic mechanism that enhances Treg function while decreasing excessive effector immune responses such as Th1 and Th17. More specifically, this manuscript discusses in-depth the therapeutic potential of LANCL2-targeting therapeutics such as omilancor, and how this new treatment modality has the potential to induce long-lasting clinical remission without the adverse side effects typical of current drugs, thereby addressing the unmet clinical needs of many patients with autoimmune diseases, starting with IBD.

Three posters with positive clinical and translational data on omilancor and LANCL2 activation in UC and CD were recently presented at the American College of Gastroenterology 2023 Annual Scientific Meeting. These posters are available under the “Publications” section of the NIMML’s website at www.nimml.org. Additionally, the peer-reviewed abstracts have been published verbatim in a special supplement to the October 2023 issue of The American Journal of Gastroenterology.

About Ulcerative Colitis (UC)

UC is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation, and ulcers in the lining of the large intestine (colon) and rectum. Symptoms include abdominal pain, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss, and malnutrition. Having UC puts a patient at increased risk of developing colon cancer. Diagnosis typically occurs in early adulthood and the disease requires maintenance treatment for the remainder of the patient’s life. UC is estimated to affect over 900,000 patients in the United States and over 1 million patients throughout the rest of the world. With 70% of addressable patients experiencing a second flare within one year and 30% of patients in remission failing to stay in remission for more than one year, there is an unmet medical need in UC for safer and more efficacious therapeutics.

About Crohn’s Disease (CD)

CD is a chronic, autoimmune, inflammatory bowel disease that causes inflammation, irritation and ulcers in any segment of the gastrointestinal tract. CD impacts the end of the small bowel and beginning of the colon most commonly, which in turn can lead to symptoms of abdominal pain, increased abdominal sounds, rectal pain and bleeding, bloody stools, diarrhea, fever, weight loss and malnutrition. There are four classes of CD and treatment depends on the level of severity. Current therapeutic options for severe disease, primarily biologics, have several limitations, which include but are not limited to safety risks for malignancies and infections, limited efficacy and lack of long-term maintenance options. There is an urgent need to establish a consensus for a first-line therapy for CD and improve upon the existing constraints in administration and efficacy.  

About Omilancor

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, NImmune expects to initiate a global pivotal Phase 3 program (PACIFY I and PACIFY II trials) in UC patients in the second half of 2023. Omilancor’s target U.S. market size is expected to be valued at $394.9 billion 2021-2030, of which a peak annual market size of $49.5 billion is expected to occur in 2030. NImmune expects peak unadjusted revenue of $12.5 billion in 2030.

About NIM-1324

NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation. NIM-1324 target U.S. market size is expected to be valued at $226.0 billion 2021-2030, of which a peak annual market size of $23.1 billion is expected to occur in 2030. NImmune expects unadjusted revenue estimates from all of NIM-1324 therapeutics to be valued at $2.3 billion from the 2028-2030 projections.

About NImmune Biopharma

NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s internal discovery platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Phase 2 first-in-patient data for omilancor in UC show potential best in class efficacy and safety. Additional information: www.NIMMUNEBIO.COM or contact media@nimmunebio.com.

Media Contact:
Alex Jeffrey/Iain Hughes
Gasthalter & Co.
NImmune@gasthalter.com 
212.257.4170

Investors and BD:
Marek Ciszewski, J.D.
Investors@NImmun.com


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