24 March 2023 - - US-based late-stage precision immunology biopharmaceutical company NImmune Biopharma has launched following the acquisition of omilancor, NIM-1324, and the entire LANCL portfolio of immunoregulatory therapeutic assets from Landos Biopharma, Inc, the company said.

Omilancor is a Phase-3-ready, once-daily, oral, gut-restricted therapeutic for Ulcerative Colitis with potentially fast-to-market follow-on opportunities in Crohn's disease and Psoriasis.

NIM-1324 is a Phase-2-ready biomarker-guided once-daily, oral therapeutic for the treatment of Systemic Lupus Erythematosus and Rheumatoid Arthritis.

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.

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 US Food and Drug Administration, 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 > 0, histological activity and elevated fecal calprotectin 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 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 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 in normal healthy volunteers where all endpoints were met, and it is now ready for further clinical testing in lupus and RA patients.

NImmune is a late-stage precision immunology biopharmaceutical company that develops best-in-class biomarker-driven immunoregulatory therapeutics.