omilancor (BT-11) / LianBio, NImmune Biopharma - LARVOL DELTA

NImmune Biopharma to Present at DDW’25 the...Translational Results for Omilancor Versus Leading Anti-TL1A in IBD Showing Superiority and Complementarity (Businesswire) - "The new findings demonstrate that oral omilancor treatment significantly ameliorated disease activity compared to anti-TL1A antibody and placebo. In addition, omilancor outperformed anti-TL1A antibodies against histological measures and in downregulating inflammatory genes implicated in the recruitment and activation of neutrophils, including Cxcl5, as well as genes typically associated with increased disease severity in inflammatory bowel disease ('IBD') and gut mucosal inflammation."

Clinical • Inflammatory Bowel Disease

NImmune Biopharma to Present at DDW’25 the First Ever Head-to-Head Clinical and Translational Results for Omilancor... (Businesswire) - P2 | N=198 | NCT03861143 | Sponsor: NImmune Biopharma | "At Digestive Disease Week 2025, presented clinical research findings demonstrated that daily oral omilancor was effective in inducing clinical remission in 30.4% of active UC patients and in 33.3% of biologic refractory UC patients at the designated Phase 3 dose of 440 mg/day. New results showed that once-daily oral omilancor treatment reverses immunometabolic dysfunction present in severe UC patients and induces clinical remission, with a biomarker response detected in as little as two weeks after initiating treatment....Results demonstrate omilancor’s commercial path to UC patients, affirm ongoing plans to complete Phase 3 development of omilancor in UC and initiate the New Drug Application (NDA) to the U.S. FDA by 2027 with additional NDAs soon thereafter."

FDA filing • P2 data • Ulcerative Colitis

NIMML Institute to Present Novel Clinical and Translational Data of Omilancor in Ulcerative Colitis Patients at Digestive Disease Week 2025 (Businesswire) - "New results to be presented in DDW elucidate omilancor’s path to patients and commercial strategy with NDA with US FDA in ulcerative colitis patients by 2027...The NIMML Institute...will present results from two novel studies for omilancor, 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, at Digestive Disease Week 2025. DDW 2025 will be held at the San Diego Convention Center from May 3-6, 2025."

Clinical data • FDA filing • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

ORAL OMILANCOR TREATMENT OUTPERFORMS ANTI-TL1A THERAPEUTICS IN IBD (DDW 2025) - No abstract available

Inflammatory Bowel Disease

OMILANCOR REVERSES COLONIC TREG DEPLETION AND MITOCHONDRIAL METABOLISM DOWNREGULATION IN SEVERE ULCERATIVE COLITIS PATIENTS (DDW 2025) - No abstract available

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

NImmune Biopharma Acquires Development and Commercialization Rights to Omilancor in Asian Markets (Businesswire) - "Topline Phase 3 clinical results in ulcerative colitis patients are anticipated by end of 2026 and the first NDA filing in 2027...NImmune Biopharma...announced the acquisition of 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....'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...'"

Commercial • Filing • New P3 trial • P3 data: top line • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

NImmune Biopharma Acquires Development and Commercialization Rights to Omilancor in Asian Markets (Businesswire) - P2 | N=198 | NCT03861143 | Sponsor: NImmune Biopharma | "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."

P2 data • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Omilancor mitigates the senescence of nucleus pulposus cells induced by DDP through targeting MAP2K6. (PubMed, Aging (Albany NY)) - "Omilancor shows promise as a treatment for IDD by targeting MAP2K6-mediated cellular senescence."

Journal • Fibrosis

Landos Biopharma Provides Business Update and Reports Fourth Quarter and Full Year 2023 Results (GlobeNewswire) - "Landos Biopharma, Inc...provided a business update and reported financial results for the fourth quarter and the full year ended December 31, 2023...Research and development expenses were $3.1 million for the fourth quarter of 2023, compared to $3.4 million for the fourth quarter of 2022. The decrease was primarily attributable to reduced clinical activities due to the wind down of the omilancor and LABP-104 programs and a reduction in NX-13 Phase 1b clinical trial expenses, partially offset by the initiation of the NX-13 Phase 2 trial; Research and development expenses were $12.0 million for the full year ended December 31, 2023, compared to $25.7 million for the full year ended December 31, 2022. The decrease was primarily attributable to reduced clinical activities due to the wind down of the omilancor and LABP-104 programs and a reduction in NX-13 Phase 1b clinical trial expenses, partially offset by the initiation of the NX-13 Phase 2 trial."

Commercial • Crohn's disease • Immunology • Inflammation • Inflammatory Bowel Disease • Lupus • Rheumatoid Arthritis • Ulcerative Colitis

Safety and Tolerability of NIM-1324, an Oral, Once-daily LANCL2 Agonist, in a Randomized, Double-Blind, Placebo-Controlled Phase 1 Study in Normal Healthy Volunteers (ACR Convergence 2023) - "Oral treatment with NIM-1324 is well tolerated and safe in humans up to the tested limit dose of 1500 mg/d. Based on the observed safety, pharmacokinetics and target engagement profile, a first-in-patient clinical trial of NIM-1324 in systemic lupus erythematosus is currently planned."

Clinical • P1 data • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Systemic Lupus Erythematosus • CD4 • LANCL2

Landos Biopharma Provides Company Update and Reports Third Quarter 2023 Results (Yahoo Finance) - "The NEXUS trial of NX-13 remains on track as the Company continues to recruit, screen and randomize patients for the trial. 20 sites in the United States and Europe have been activated....Research and development expenses were $3.1 million for the third quarter of 2023, compared to $4.9 million for the third quarter of 2022. The decrease was primarily attributable to the wind down of omilancor and LABP-104 clinical trials and a reduction in NX-13 Phase 1b clinical trial costs, partially offset by initiation of the NEXUS trial."

Commercial • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Treating Autoimmune Diseases With LANCL2 Therapeutics: A Novel Immunoregulatory Mechanism for Patients With Ulcerative Colitis and Crohn's Disease. (PubMed, Inflamm Bowel Dis) - "Omilancor, the most advanced LANCL2 immunoregulatory therapeutic in late-stage clinical development, is a phase 3 ready, first-in-class, gut-restricted, oral, once-daily, small-molecule therapeutic in clinical development for the treatment of UC and CD. In this review, we discuss this novel mechanism of mucosal immunoregulation and how LANCL2-targeting therapeutics could help address the unmet clinical needs of patients with autoimmune diseases, starting with IBD."

Journal • CNS Disorders • Crohn's disease • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Multiple Sclerosis • Psoriasis • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus • Ulcerative Colitis • CD4 • IL2 • IL2RA • LANCL2

Transcriptional Analysis of Colonic Biopsies from Patients with Ulcerative Colitis Treated with Omilancor (ACG 2023) - "Differentially expressed genes upregulated by omilancor relative to baseline and placebo were associated with lipid metabolism and ion balance in addition to known elements of the LANCL2 pathway. Meanwhile, downregulated genes were associated with immune system processes, primarily those in relation to neutrophils and leukocyte trafficking. Predictive modeling of gene expression changes from baseline was able to differentiate patients treated with omilancor from those given placebo with 83% accuracy."

Biopsy • Clinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Metabolic Disorders • Ulcerative Colitis • CD4 • LANCL2

Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Ulcerative Colitis (ACG 2023) - "Oral omilancor was well tolerated with no trends in AE profile observed and no dose-limiting toxicities. In the mITT population, clinical remission was induced in 30.4% of omilancor treated patients relative to 3.7% of patients given placebo (Δ = 26.7, P = 0.01). Endoscopic remission, defined as a MES < 2 was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo (Δ = 23.1, P = 0.07)."

Clinical • P2 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CD4 • LANCL2

Efficacy and Safety of Omilancor in a Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Crohn’s Disease (ACG 2023) - "Oral omilancor was well tolerated with no trends in AE profile observed and no SAEs related to study drug. Clinical remission was induced in 25.0% of patients within the omilancor group relative to 9.1% of the placebo group (Δ = 15.9). Similar effect sizes were observed within biologic experienced (Δ = 20.0) and biologic naïve (Δ = 14.3) subpopulations in clinical remission."

Clinical • P2 data • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Pain • Ulcerative Colitis • CD4 • LANCL2

NImmune Biopharma Announces Positive Results of Omilancor in Ulcerative Colitis and Crohn’s disease at the American College of Gastroenterology 2023 Annual Scientific Meeting (Businesswire) - P2 | N=198 | NCT03870334 | Sponsor: NImmune Biopharma | "PRO-2 clinical remission was achieved in 41.7% of moderate to severe CD patients in the omilancor group relative to 9.1% give placebo (Δ=32.6). Crohn’s disease activity index (CDAI) clinical remission was achieved in 25.0% of omilancor-treated patients relative to 9.1% of the placebo group (Δ=15.9). Omilancor demonstrated a promising efficacy signal in both biologic naïve and biologic-experienced moderate to severe CD patients."

P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

NImmune Biopharma Announces Positive Results of Omilancor in Ulcerative Colitis and Crohn’s disease at the American College of Gastroenterology 2023 Annual Scientific Meeting (Businesswire) - P2 | N=198 | NCT03861143 | Sponsor: NImmune Biopharma | "NImmune Biopharma...announced that it will present three abstracts, including final Phase 2 data for omilancor in active Ulcerative Colitis patients at the American College of Gastroenterology ('ACG') 2023 Annual Scientific Meeting ('ACG 2023'), taking place at the Vancouver Convention Center in Vancouver, Canada, between October 20 and October 25, 2023....Clinical remission in the approvable UC population of active disease mild to severe patients was induced in 30.4% of patients treated with omilancor relative to 3.7% of patients given placebo (Δ=26.7, P = 0.01), meeting the primary endpoint. Endoscopic and histological remission were achieved in 41.7% of omilancor given patients relative to 18.6% and 22.2%, respectively, patients in the placebo group (Δ=23.1, Δ=19.5)."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Oral Omilancor Treatment Ameliorates Clostridioides difficile Infection During IBD Through Novel Immunoregulatory Mechanisms Mediated by LANCL2 Activation. (PubMed, Inflamm Bowel Dis) - "These data support the development of omilancor as a novel host-targeted, antimicrobial-free immunoregulatory therapeutic for the treatment of IBD patients with C. difficile-associated disease and pathology with the potential to address the unmet clinical needs of ulcerative colitis and Crohn's disease patients with concomitant CDI."

Journal • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis • LANCL2

Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn's Disease (clinicaltrials.gov) - P2 | N=27 | Terminated | Sponsor: NImmune Biopharma | Completed ➔ Terminated; Decision of Landos Biopharma (not related to safety or efficacy)

Trial termination • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

NImmune Biopharma Provides Update on Omilancor Clinical Development Programs in Ulcerative Colitis and Crohn’s Disease (Businesswire) - P2 | N=NA | "NImmune Biopharma...announced Phase 2 data on an approvable population of ulcerative colitis (UC) patients and its plans to initiate a registration directed global Phase 3 program for omilancor for the treatment of UC....clinical remission was induced in 30.4% of omilancor treated patients relative to 3.7% of patients given placebo (Δ = 26.7, p = 0.01), thereby meeting the primary endpoint. Endoscopic remission was induced in 41.7% of patients treated with omilancor relative to 18.6% of patients given placebo (Δ = 23.1, p = 0.07)....In a small clinical trial in biologic naïve and biologic experienced moderate to severe Crohn’s disease patients omilancor showed encouraging efficacy signals in clinical remission at week 12...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."

New P3 trial • P2 data • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Landos Biopharma Provides Business Update and Reports First Quarter 2023 Results (GlobeNewswire) - "Research and development expenses were $3.3 million for the first quarter of 2023, compared to $10.8 million for the first quarter of 2022. The decrease was primarily attributed to reduced clinical activities for omilancor and LABP-104 programs due to the wind down of the related clinical trials, as well as decreases in consulting costs and depreciation expense."

Commercial • Atopic Dermatitis • Crohn's disease • Immunology • Inflammatory Bowel Disease • Psoriasis • Ulcerative Colitis

Landos Biopharma Provides Business Update and Reports Fourth Quarter and Full Year 2022 Results (GlobeNewswire) - "Research and development expenses were $25.7 million for the full year ended December 31, 2022, compared to $41.6 million for the full year ended December 31, 2021. The decrease was primarily attributed to reduced clinical activities due to the wind down of omilancor and LABP-104 related clinical trials, as well as decreases in employee-related expenses, partially offset by increases in costs associated with the clinical development of NX-13."

Commercial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CLINICAL EFFICACY, SAFETY AND TOLERABILITY OF OMILANCOR (BT-11) AS INDUCTION THERAPY FOR ACTIVE ULCERATIVE COLITIS: SEVERITY DRIVEN ANALYSIS OF A 12-WEEK PHASE 2 STUDY (DDW 2023) - "In this phase 2 study in patients with moderate UC, we find clear indication of efficacy for Omilancor. Low Dose Omilancor (440mg) showing the highest clinical remission and endoscopic remission rates compared to placebo. Omilancor was well tolerated and safe."

Clinical • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Mucositis • Ulcerative Colitis • LANCL2

Josep Bassaganya-Riera Launches NImmune Biopharma with Phase 3-Ready Clinical Candidate Omilancor for the Treatment of Ulcerative Colitis and Crohn’s Disease (Businesswire) - “NImmune Biopharma…announced its launch following the acquisition of omilancor, NIM-1324, and the entire LANCL portfolio of immunoregulatory therapeutic assets from Landos Biopharma, Inc….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….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.”

M&A • New P3 trial • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Landos Biopharma Announces Transfer of LANCL Portfolio, including Omilancor, LABP-104 and LABP-111 to Landos’ Founder (BioSpace) - "Landos Biopharma, Inc...announced the transfer of its LANCL portfolio, including Omilancor, LABP-104 and LABP-111 to Dr. Josep Bassaganya-Riera, Ph.D., the founder of Landos who previously served as its Chairman, President and CEO, and certain affiliated individuals and entities....Under the terms of the transaction, the Company will repurchase approximately [9.1] million Landos shares previously held by Dr. Bassaganya-Riera and certain affiliated individuals and entities..."

Licensing / partnership • Crohn's disease • Inflammatory Bowel Disease • Systemic Lupus Erythematosus • Ulcerative Colitis