NIM-1324 / NImmune Biopharma - LARVOL DELTA

NIM-1324 Activates LANCL2 to Reduce Recurrence and Disease Severity in Inflammatory Bowel Disease and Clostridioides Difficile Infection Co-Occurrence Models (ACG 2026) - "Recurrent CDI was induced by gavage of VPI10463 one day after a clindamycin intraperitoneal injection, with a second injection occurring 12 days post-infection. NIM-1324 treatment reduced weight loss and disease activity scores, while improving survival relative to vehicle and antibiotic therapy. During the recurrent phase of infection, NIM-1324 reduced the frequency of a positive C. difficile test to vehicle and antibiotic therapy. Microbial alpha and beta diversity during acute and recurrent phases were increased with NIM-1324 treatment."

Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • CD4 • IL2RA • ISG20 • LANCL2

NImmune Biopharma…will present two studies at the American College of Gastroenterology 2026 Annual Scientific Meeting ('ACG 2026'), which together demonstrate the potential of the novel LANCL2 mechanism in treating IBD patients with difficult disease courses (Businesswire) - "The abstracts, titled 'LANCL2 Activation Ameliorates Immune and Metabolic Transcriptional Patterns Associated with Biologic Refractoriness in Ulcerative Colitis and Crohn’s Disease' and 'NIM-1324 activates LANCL2 to reduce recurrence and disease severity in inflammatory bowel disease and Clostridioides difficile infection co-occurrence models' will present clinical data and preclinical evidence highlighting how the novel LANCL2 mechanism can benefit patient populations underserved by currently approved medications."

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

NImmune Biopharma Announces Presentations at Digestive Disease Week 2026 Supporting a Differentiated Profile and Superior Efficacy of Oral, Once-Daily NIM-1324 for IBD (Businesswire) - "A well-powered Phase 2 clinical trial of NIM-1324 will test 125, 250, and 1000 mg doses versus placebo to evaluate clinical remission and target engagement in ulcerative colitis patients...New data presented at DDW demonstrates that NIM-1324 outperforms current IBD medications, establishes Phase 1 safety, tolerability and LANCL2 target engagement in humans...NIM‑1324 targets a dual LANCL2 mechanism that activates Tregs’ anti-inflammatory actions and enhances mitochondrial metabolism. Given its improved PK profile, NIM-1324 elicits its pharmacological actions by combining gut localized activity with systemic immunoregulatory effects via LANCL2 pathway activation to address symptoms both inside and outside the gut, including extraintestinal manifestations of disease."

New P2 trial • P1 data • Preclinical • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

The NIMML Institute and NImmune Biopharma Announce Publication of Positive First-in-Human Data of NIM-1324, a Phase 2 Candidate for Systemic Lupus Erythematosus, in Clinical and Translational Science (Businesswire) - P1 | N=56 | NCT05019950 | Sponsor: NImmune Biopharma | "Among the results of the study, single or multiple oral dosing with NIM-1324 for up to 1500 mg/d did not produce severe adverse effects (AE) or increased total AE rates compared to placebo. No significant findings were observed by biochemistry, coagulation, hematology, or urinalysis relative to placebo. Additionally, dose-proportional change in plasma exposure within the therapeutic range was reported with no accumulation during the dosing period. Oral NIM-1324 upregulated expression of mitochondrial metabolism genes, while downregulating markers of phagocyte activation, in correlation with the whole blood transcriptomic signature generated in preclinical therapeutic efficacy programs."

P1 data • Systemic Lupus Erythematosus

Safety, Tolerability, and Pharmacokinetics of NIM-1324 an Oral LANCL2 Agonist in a Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial. (PubMed, Clin Transl Sci) - "At 250 mg, NIM-1324 successfully engaged the target with an upregulation of Lancl2 and key transcriptional biomarkers in whole blood. In conclusion, NIM-1324 treatment is well-tolerated up to daily oral doses of at least 1500 mg (nominal), a ≥ six-fold margin over the anticipated therapeutic dose, and 1000 mg (maximum observed exposure), at least a four-fold margin over the anticipated therapeutic dose with no dose limiting toxicities."

Clinical • Journal • P1 data • PK/PD data • Hematological Disorders • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus • CD4 • CXCL8 • IL6 • LANCL2

The NIMML Institute and NImmune Biopharma Announce Publication of New Mechanistic Insights on the Immunometabolic Control of Systemic Lupus Erythematosus in the Journal of Immunology (Businesswire) - "NIM-1324 validated as the first LANCL2 drug with therapeutic efficacy in systemic inflammation in three mouse models of lupus to support immune tolerance....The NIMML Institute...today announced the publication of a seminal article that reports the mechanisms of therapeutic efficacy of NIM-1324, an orally administered LANCL2 agonist, in ameliorating the severity of Systemic Lupus Erythematosus (SLE) and addressing the unmet clinical needs of SLE patients. These novel mechanistic findings were published in the Journal of Immunology....The study characterized the importance of LANCL2 in SLE by using loss-of-function studies in vivo and evaluated the therapeutic efficacy of NIM-1324 in murine models of SLE, including NZB/W, MRL/lpr, and bm12 adoptive transfer models."

Preclinical • Systemic Lupus Erythematosus

Immunometabolic Mechanisms of LANCL2 in CD4+ T Cells and Phagocytes Provide Protection from Systemic Lupus Erythematosus. (PubMed, J Immunol) - "This efficacy translated to human PBMCs from patients with SLE, because ex vivo treatment with NIM-1324 resulted in reduced levels of IFN-α, IL-6, and IL-8. Consequently, the activation of LANCL2 effectively modulates CD4+ T cell differentiation and phagocyte activation, supporting immune tolerance in SLE."

Journal • Immunology • Inflammation • Inflammatory Arthritis • Lupus • Renal Disease • Systemic Lupus Erythematosus • CD4 • CXCL8 • FOXP3 • IFNA1 • IL17A • IL21 • IL6 • LANCL2

Pharmacological activation of LANCL2 ameliorates disease severity and decreases inflammation in a preclinical model of rheumatoid arthritis (IMMUNOLOGY 2024) - "In human peripheral blood mononuclear cells, NIM-1324 decreased secretion of inflammatory mediators. This data supports that the pharmacological activation of LANCL2 by NIM-1324 is a promising therapeutic approach for the treatment of RA."

Late-breaking abstract • Preclinical • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD4 • IL17A • IL2 • IL21 • IL2RA • LANCL2

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

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

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

Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Landos Biopharma Inc. | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers (clinicaltrials.gov) - P1 | N=56 | Recruiting | Sponsor: Landos Biopharma Inc. | Trial completion date: Dec 2021 ➔ Apr 2022 | Trial primary completion date: Dec 2021 ➔ Apr 2022

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

[VIRTUAL] Therapeutic Efficacy of BT-104, an Oral LANCL2 Agonist, for the Treatment of Systemic Lupus Erythematosus (ACR-CONVERGENCE 2021) - "LANCL2 is a novel anti-inflammatory target that has been first targeted by a gut-restricted compound, omilancor (BT-11), currently in Phase II/III clinical development for inflammatory bowel diseases... Based on the preclinical data generated, BT-104 is a promising therapeutic for systemic lupus erythematosus and other rheumatic conditions. BT-104 is expected to enter Phase I clinical testing in normal healthy volunteers in Q4 2021."

Clinical • Gastroenterology • Gastrointestinal Disorder • Glomerulonephritis • Immunology • Inflammation • Inflammatory Arthritis • Inflammatory Bowel Disease • Lupus • Renal Disease • Systemic Lupus Erythematosus • CD4 • FOXP3 • IL17A • IL21 • IL2RA • LANCL2 • TLR7

Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: Landos Biopharma Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Landos Biopharma Announces First Subject Dosed in a Phase 1 Study of LABP-104 for Systemic Lupus Erythematosus (GlobeNewswire) - "Landos Biopharma, Inc...today announced the Company has dosed the first subject in a Phase 1 study of LABP-104...for the treatment of systemic lupus erythematosus (SLE)....The Phase 1 trial is a randomized, placebo-controlled, double-blind, ascending dose, multi-cohort study designed to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. A total of 56 healthy volunteers will be enrolled in two parts – a single ascending dose study (SAD) and then a multiple ascending dose study (MAD)....The primary endpoint will measure the safety and tolerability of LABP-104. Secondary endpoint will measure the pharmacokinetics of LABP-104. We expect to report topline results of the Phase 1 trial in the first half of 2022."

P1 data • Trial status • Immunology • Lupus • Systemic Lupus Erythematosus

Landos Biopharma Announces FDA Clearance of its IND for LABP-104 for the Treatment of Systemic Lupus Erythematosus (GlobeNewswire) - "Landos Biopharma, Inc...today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for LABP-104...for the treatment of systemic lupus erythematosus (SLE). Landos plans to initiate a Phase 1 trial in healthy volunteers before yearend and report topline results in the first half of 2022....The planned Phase 1 trial is a randomized, placebo-controlled, double-blind, ascending dose, multi-cohort study designed to evaluate the safety, tolerability and pharmacokinetics of LABP-104 in healthy volunteers. A total of 56 healthy volunteers will be enrolled in two parts – a single ascending dose study (SAD) and then a multiple ascending dose study (MAD)....The primary endpoint will measure the safety and tolerability of LABP-104. The secondary endpoint will measure the pharmacokinetics of the once-daily oral therapeutic."

IND • New P1 trial • P1 data • Immunology • Lupus • Systemic Lupus Erythematosus

Landos Biopharma to Present Results of LABP-104 in Lupus at the American College of Rheumatology Convergence 2021 (GlobeNewswire) - “Oral treatment with LABP-104 in preclinical models of Systemic Lupus Erythematosus (SLE) resulted in enhanced Treg function, decreased kidney inflammation and reduced interferon gamma signaling….Landos Biopharma, Inc…today announced that it will present preclinical data of LABP-104, an oral, small-molecule LANCL2 agonist, in Systemic Lupus Erythematosus (SLE or Lupus) as an oral presentation at the upcoming American College of Rheumatology (ACR) Convergence 2021. The meeting will be held virtually from November 3-10, 2021….Landos expects to enter Phase 1 clinical testing of LABP-104 as an oral therapeutic candidate for lupus during the fourth quarter of 2021, further expanding the company’s deep inflammation and immunology pipeline.”

Preclinical • Trial initiation date • Immunology • Lupus • Systemic Lupus Erythematosus

"$LABP Landos Biopharma to Present Results of LABP-104 in Lupus at the American College of Rheumatology Convergence 2021 https://t.co/UwiyAQDIVa" (,@stock_titan)

Immunology • Inflammatory Arthritis • Lupus • Rheumatology

Safety Tolerability and Pharmacokinetics of Oral LABP-104 in Healthy Adult Male and Female Volunteers (clinicaltrials.gov) - P1; N=56; Not yet recruiting; Sponsor: Landos Biopharma Inc.

Clinical • New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus