NImmune Biopharma to Present Clinical and Preclinical Data on NIM-1324 at ACG 2026, Highlighting LANCL2 Potential in Difficult-to-Treat IBD
NImmune Biopharma, a private, late-stage precision inflammation and immunology (I&I) biopharmaceutical company, is set to present two studies at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting, highlighting the potential of its investigational oral therapy NIM-1324 and its novel LANCL2 mechanism in patients with challenging inflammatory bowel disease (IBD).
The presentations will bring together clinical and preclinical findings focused on ulcerative colitis (UC) and Crohn’s disease (CD), two major forms of IBD in which a substantial number of patients experience inadequate responses, loss of response or intolerance to currently available therapies. According to NImmune, the new data support the potential of LANCL2 activation to address both inflammatory and metabolic pathways that contribute to disease persistence and treatment resistance.
The company will present its findings on Sunday, October 11, 2026, at ACG 2026. The two abstracts provide complementary evidence for NIM-1324, including data examining transcriptional patterns associated with biologic refractoriness as well as preclinical findings involving IBD and concurrent Clostridioides difficile infection (CDI).
The studies are 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.”
Together, the findings are intended to demonstrate how NIM-1324 could potentially address disease mechanisms that are not fully controlled by existing IBD therapies and provide a treatment option for patient populations with difficult disease courses.
Addressing Biologic Refractoriness in IBD
One of the key areas highlighted by NImmune at ACG 2026 is biologic-refractory IBD. Although biologic therapies have significantly changed the treatment landscape for UC and CD, many patients do not achieve adequate disease control. Others may initially respond and subsequently lose therapeutic benefit.
Treatment resistance in IBD can involve complex interactions between immune signaling, inflammatory cell recruitment, tissue remodeling and metabolic dysfunction. NImmune’s research is focused on LANCL2 as a mechanism capable of influencing both immune and metabolic processes.
The first ACG presentation evaluates how activation of LANCL2 affects immune and metabolic transcriptional patterns associated with biologic refractoriness in UC and CD. The findings are expected to provide insight into the biological processes that may distinguish difficult-to-treat disease and explain why some patients respond inadequately to existing therapies.
According to NImmune, LANCL2 activation has the potential to counteract several pathways associated with persistent inflammation and refractory disease. These include granulocyte chemotaxis, profibrotic mediators and abnormalities in metabolic processes.
The company describes NIM-1324 as an immunometabolic therapy designed to activate LANCL2 through a dual mechanism. This approach is intended to enhance regulatory T-cell, or Treg, anti-inflammatory activity while also improving mitochondrial metabolism.
By simultaneously influencing immune regulation and cellular metabolism, NIM-1324 is being developed with the goal of addressing multiple biological components of IBD rather than focusing exclusively on a single inflammatory pathway.
Potential Role in IBD Patients With C. difficile Infection
The second study addresses another important challenge in IBD management: the occurrence of Clostridioides difficile infection in patients with underlying inflammatory bowel disease.
CDI can complicate the clinical management of UC and CD because infection and intestinal inflammation can produce overlapping symptoms, including diarrhea, abdominal pain and worsening gastrointestinal disease. In addition, an infection may trigger an IBD flare, creating a difficult treatment dilemma for physicians.
Historically, IBD therapies may be reduced or discontinued when a patient develops CDI because of concerns that immunosuppressive treatment could worsen the infection or affect its clinical course. However, interrupting effective IBD treatment can also contribute to renewed inflammatory activity and worsening disease symptoms.
NImmune’s preclinical data presented at ACG 2026 are intended to explore whether NIM-1324 could offer a different approach in this setting.
The company reports that its findings indicate NIM-1324 was safe to continue during infection in the models studied and may have reduced infection severity as well as the likelihood of recurrence. The data also suggest that activation of LANCL2 could influence both IBD-associated inflammation and biological processes related to CDI.
These findings are particularly relevant because recurrent CDI remains a concern in patients with IBD. A treatment strategy that could potentially help control intestinal inflammation while also avoiding exacerbation of infection could represent an important addition to the therapeutic landscape.
The company emphasizes that these findings are based on preclinical co-occurrence models and will require further clinical evaluation to determine whether the observed effects translate to patients.
Dual Immunometabolic Mechanism of NIM-1324
At the center of NImmune’s development strategy is LANCL2, a therapeutic target the company believes can provide a differentiated approach to inflammatory and autoimmune diseases.
NIM-1324 is designed to activate LANCL2 and engage two complementary biological functions. The first involves the immune system, particularly enhancement of regulatory pathways associated with Tregs and their anti-inflammatory activity. The second involves cellular metabolism, including mitochondrial function.
IBD is driven by an imbalance between immune activation and mechanisms responsible for maintaining intestinal immune tolerance. At the same time, metabolic changes within immune and intestinal cells can influence inflammatory activity, tissue function and disease progression.
NImmune believes that targeting LANCL2 allows NIM-1324 to address these interconnected processes simultaneously.
The company’s research suggests that LANCL2 activation may counteract biological signatures associated with refractory IBD, including increased granulocyte recruitment, profibrotic signaling and disrupted metabolic pathways. These mechanisms may be particularly relevant in patients whose disease remains active despite treatment with established biologic medicines.
The dual pharmacological approach therefore represents an effort to move beyond conventional single-pathway inhibition and toward precision immunometabolic treatment.
Company Highlights Potential to Reshape IBD Treatment
“ACG provides a phenomenal forum to share how NIM-1324 can reshape the treatment paradigm for ulcerative colitis and Crohn’s disease,” said Dr. Josep Bassaganya-Riera, Founder, Executive Chairman, President and Chief Executive Officer of NImmune Biopharma.
Bassaganya-Riera emphasized the company’s view that LANCL2 represents a differentiated therapeutic target because of its ability to address both immune and metabolic dysfunction.
“LANCL2, NIM-1324’s therapeutic target, is the only mechanism of action in clinical development capable of resolving both the immunological and metabolic challenges associated with IBD,” he said.
He added that the dual-targeted pharmacology of LANCL2 medicines could play an important role in improving therapeutic outcomes among patients with hard-to-treat and refractory IBD.
NImmune’s presence at ACG 2026 provides the company with an opportunity to showcase the breadth of its LANCL2 development program, particularly its focus on patients who may not be adequately served by existing therapies.
Broader Implications for Precision Inflammation and Immunology
The studies being presented at ACG 2026 build on NImmune’s broader research at the intersection of immunity and metabolism. The company has been investigating LANCL2-based therapeutic approaches across multiple inflammatory, autoimmune and central nervous system indications.
The underlying research strategy is based on the concept that immune dysfunction and metabolic abnormalities are closely interconnected across a range of chronic diseases. By influencing both systems, NImmune aims to develop therapies capable of producing broader biological effects than approaches that target inflammatory signaling alone.
For IBD, this strategy could be particularly relevant because UC and CD involve complex disease biology, heterogeneous patient populations and variable responses to available treatments.
The findings concerning biologic refractoriness could help establish a biological rationale for using LANCL2 activation in patients who have failed or become refractory to established therapies. Meanwhile, the CDI co-occurrence data could potentially open another avenue for investigation in a clinically challenging population where physicians must balance control of IBD inflammation with management of infection.
However, further clinical studies will be important to establish the safety, efficacy and long-term therapeutic benefits of NIM-1324 in these patient populations.
NImmune’s two presentations at ACG 2026 represent an important update for the company’s NIM-1324 development program. By combining clinical evidence with preclinical research, the company is seeking to demonstrate that LANCL2 activation may have utility across multiple difficult aspects of IBD management.
The data will focus particular attention on biologic-refractory UC and CD and on models in which IBD occurs alongside C. difficile infection. These populations represent significant unmet medical needs because conventional treatment strategies can be limited by inadequate efficacy, treatment resistance, infection-related complications or the need to modify therapy during acute infection.
NIM-1324’s proposed dual mechanism—enhancing Treg-mediated anti-inflammatory activity while supporting mitochondrial metabolism—forms the foundation of NImmune’s precision immunometabolic approach.
The presentations scheduled for October 11, 2026, at ACG 2026 will provide the gastroenterology community with additional information on the potential of LANCL2 activation in IBD and the company’s efforts to develop therapies for patients with challenging disease courses.
As NImmune advances its clinical development program, additional clinical evidence will be needed to determine whether the promising mechanistic and preclinical findings can translate into meaningful improvements for people living with UC and CD. For now, the ACG 2026 data add to the growing body of research supporting LANCL2 as a potential therapeutic pathway at the intersection of inflammation, immune regulation and cellular metabolism.
About NImmune Biopharma
NImmune is a private late-stage precision inflammation and immunology (“I&I”) biopharmaceutical company that leverages a proprietary A.I. platform to rapidly and capital efficiently develop novel best-in-class biomarker-driven immunoregulatory therapeutics for metabolic, inflammatory and autoimmune diseases.
Underpinned by the TITAN-X computational platform that utilizes advanced A.I., advanced computational modeling, and bioinformatics and biomedical research capabilities to pioneer innovation in the development and commercialization of novel best-in-class I&I therapies, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates to New Drug Application (NDA) filing and commercialization. Additional information: www.NIMMUNEBIO.COM.
About NIMML
The NIMML Institute is a 501(c)(3) non-profit foundation dedicated to combining advanced artificial intelligence–driven computational modeling with translational research and clinical testing to accelerate development of the next wave of precision medicines for inflammatory and autoimmune diseases. The Institute applies its TITAN-X™ advanced A.I.-powered platform to large-scale, transdisciplinary projects aimed at solving important public health challenges through precision immunology. The NIMML Institute is headquartered in Blacksburg, Virginia. For more information, please visit www.NIMML.org.