Josep Bassaganya-Riera Launches NImmune Biopharma with Phase 3-Ready Clinical Candidate Omilancor for the Treatment of Ulcerative Colitis and Crohn’s Disease

BLACKSBURG, Va.--(BUSINESS WIRE)-- NImmune Biopharma (“NImmune”), a late-stage precision immunology biopharmaceutical company that develops best-in-class biomarker-driven immunoregulatory therapeutics, today announced its launch following the acquisition of omilancor, NIM-1324, and the entire LANCL portfolio of immunoregulatory therapeutic assets from Landos Biopharma, Inc.

Omilancor is a Phase-3-ready, once-daily, oral, gut-restricted therapeutic for Ulcerative Colitis (UC) with potentially fast-to-market follow-on opportunities in Crohn’s disease (CD) and Psoriasis. NIM-1324 is a Phase-2-ready biomarker-guided once-daily, oral therapeutic for the treatment of Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA). These clinical candidates, originally developed by NImmune’s Founder, Executive Chairman, President, and Chief Executive Officer Dr. Josep Bassaganya-Riera, activate the Lanthionine Synthetase C-Like 2 (LANCL2) pathway, which enhances immunoregulatory processes that provide protection from autoimmune disease.

“I am thrilled to regain ownership and leadership of the LANCL immunoregulatory therapeutic portfolio and look forward to continuing the development of these candidates at NImmune, a science-driven company developing best-in-class biomarker-driven immunoregulatory therapeutics for a growing patient population with autoimmune diseases and unmet medical needs,” stated Dr. Bassaganya-Riera, Founder & CEO of NImmune. “Our leadership team was instrumental in the creation of the LANCL immunoregulatory portfolio, and brings substantial experience working with omilancor specifically to NImmune. Omilancor has the potential to impact the global inflammatory bowel disease (IBD) market as a safe and effective therapy, given the statistically significant clinical remission data it has produced in active disease UC patients as well as promising efficacy and safety results in CD patients. We are highly encouraged and motivated by these results and are pleased to have identified a robust regulatory path to commercialization.”

Omilancor was previously evaluated for the treatment of UC in a Phase 2 randomized, placebo-controlled clinical trial that demonstrated biologic-like efficacy with potentially best-in-class safety. Based on these findings and positive correspondence with the U.S. Food and Drug Administration (FDA), NImmune plans to initiate a Phase 3 randomized, placebo-controlled clinical trial in 2023. This study will be similar in design to the previous study but will only include the 440mg dose and utilize refined criteria for active disease, that includes rectal bleeding (RB) > 0, histological activity and elevated fecal calprotectin (FCP) at baseline. An analysis of the Phase 2 data using the 440mg dose and the refined active disease population attained statistically significant clinical remission at week 12. Meeting the approvable primary endpoint in its planned Phase 3 population of active disease UC patients sets a robust regulatory path for omilancor to New Drug Application (NDA) filing and commercialization.

A summary of the Phase 2 omilancor data can be found in NImmune’s corporate presentation.

NImmune’s second pipeline clinical candidate, NIM-1324, a once-daily, oral, systemically distributed LANCL2 agonist, has demonstrated ability to induce enhanced regulatory T cell (Treg) function in preclinical models of SLE and RA, reduced interferon gamma signaling in human peripheral blood mononuclear cells, and the potential to reduce inflammatory cell infiltration with less toxicity than current standard of care, including biologics and JAK-inhibitors. Additionally, Phase 2-ready NIM-1324 successfully completed a Phase 1 randomized, double-blind, placebo-controlled multi-cohort study evaluating its safety, tolerability, and pharmacokinetics (PK) in normal healthy volunteers where all endpoints were met, and it is now ready for further clinical testing in lupus and RA patients.

About NImmune Biopharma

NImmune is a late-stage precision immunology biopharmaceutical company that develops best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by advanced computational modeling 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. NImmune’s clinical development pipeline includes omilancor, a Phase 3-ready lead clinical candidate targeting LANCL2, an oral, once-daily, gut-restricted, first-in-class therapeutic for Ulcerative Colitis and Crohn’s disease with registration-directed pivotal clinical trials planned for 2023. Additional information: www.NIMMUNEBIO.COM or contact media@nimmunebio.com.

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