NImmune Biopharma, a private late-clinical-stage precision inflammation and immunology (I&I) biopharmaceutical company, has acquired development and commercialization rights for omilancor in Asia. Covered markets include China, Macau, Hong Kong, Taiwan, Thailand, Singapore, South Korea, Cambodia, Indonesia, Myanmar, the Philippines, Thailand, and Vietnam.
 
Upon closing of this transaction, NImmune will wholly own global rights to omilancor and the entire LANCL2 portfolio of immunoregulatory therapeutics. Omilancor is a once-daily, oral, best- and first-in-class therapy in Phase 3 clinical development for ulcerative colitis (UC) and Phase 2 for Crohn’s disease (CD), with multiple I&I indications planned.
 
“The wind-down of LianBio, announced on February 13, 2024, provided an unprecedented opportunity to consolidate global rights to omilancor in NImmune and capture significant additional value for shareholders. We are very excited to continue late-stage development of omilancor and bring the best- and first-in-class potential of an oral therapeutic to patients with ulcerative colitis and Crohn’s disease,” said Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune. “The timing of this transaction could not have been more ideal as we launch the global Phase 3 program of omilancor in UC. We now look forward to completing ongoing discussions with potential global and regional strategic partners that can help to further accelerate Phase 3 timelines and bring the best-in-class potential of omilancor to address the unmet needs of millions of IBD patients in the U.S. and worldwide.”

How Omilancor Works

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators such as TNF, increasing anti-inflammatory functions in regulatory T cells (Treg) and phagocytes within the site of inflammation while decreasing excessive or pathogenic effector immune responses such as Th1 and Th17. LANCL2 activation enhances the anti-inflammatory functions of Treg cells by amplifying IL-2 signaling and promoting metabolic reprogramming resulting in enhanced mitochondrial metabolism. Over 90% of downregulated genes in IBD are related to mitochondrial metabolism. Activation of LANCL2 with omilancor reverses this downregulation.
 
In a Phase 2 double-blind, randomized, placebo-controlled trial, oral once daily omilancor induced clinical remission in 30.4% of patients with active UC (78% w/ baseline MES of 3) or, a placebo-adjusted 26.7% (P = 0.01) with no identified treatment related adverse events.
 
Ongoing development of a precision biomarker signature intended to serve as a companion diagnostic to omilancor may help to more precisely identify responders and maximize enduring clinical remission. Omilancor’s predictive biomarkers were developed with the guidance of the NIMML Institute’s TITAN-X platform, a proprietary advanced computational modeling and AI-powered precision medicine discovery engine that efficiently accelerates biomarker-driven I&I therapeutic development.