NImmune Biopharma, a late-stage precision immunology biopharmaceutical company that develops biomarker-driven immunoregulatory therapeutics, 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).

The clinical candidates 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,” said 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.”

According to the company, 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. 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, according to the company.

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.

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.