NIMML Institute’s TITAN-X A.I.-Powered Precision Medicine Platform Validated through AbbVie’s Acquisition of Landos Biopharma and Lead Clinical Candidate NX-13

NIMML founders Dr. Bassaganya-Riera, Dr. Hontecillas, and scientific director Dr. Leber discovered, characterized, and led the development of NX-13 from discovery to successful clinical testing in Ulcerative Colitis (UC) patients.

NIMML’s TITAN-X, an A.I. powered precision medicine platform, has also guided the target discovery and biomarker-driven development of first and best in class LANCL2 agonists, including omilancor, in Phase 3 development as a once daily, gut-restricted oral therapeutic in Ulcerative Colitis by NImmune Biopharma.

Novel scientific discoveries made by the NIMML Institute team continue to yield novel druggable targets for autoimmune diseases and strengthen a global pipeline for safer and more effective oral I&I therapeutics.

Blacksburg, VA, March 25, 2024 – The NIMML Institute (“NIMML”), a 501 (c)(3) nonprofit institute dedicated to the discovery of novel precision medicines for autoimmune diseases, today recognized its co-founders, Dr. Josep Bassaganya-Riera and Dr. Raquel Hontecillas, and scientific director Dr. Andrew Leber for their leadership in the discovery and development of NX-13 that enabled today’s acquisition of Landos Biopharma, Inc. (“Landos”) by AbbVie, Inc. (NYSE: ABBV) (“AbbVie”). Dr. Bassaganya-Riera founded Landos in 2017 and led the Company’s subsequent growth from inception through multiple rounds of private funding, a successful IPO, growth as a NASDAQ-listed biopharma company with market capitalization in excess of $625 million, 7 INDs and 17 therapeutic development programs, including the successful clinical development of NX-13 and omilancor for the treatment of ulcerative colitis (UC) and potentially other autoimmune diseases.

“NIMML’s TITAN-X Precision Medicine platform and its advanced A.I. and computational modeling capabilities were instrumental for the characterization of NLRX1 as a therapeutic target for autoimmune diseases and the development of NX-13. The acquisition of Landos and NX-13 by AbbVie, the maker of several blockbuster IBD drugs, validates the value of the TITAN-X platform to discover a portfolio of first and best in class biomarker-driven immunoregulatory therapeutics for inflammatory and autoimmune diseases with high unmet patient needs,” said Dr. Bassaganya-Riera, President and CEO of NIMML. “Importantly, AbbVie is one of the world’s largest biopharma companies with an incredibly successful I&I franchise that it has built over the last two decades. This transaction is a tremendous validation of the work and dedication of the entire NIMML team and the robustness of the TITAN-X drug discovery platform in strengthening a global pipeline of I&I therapeutics.”

Drs. Bassaganya-Riera, Hontecillas and Leber were the sole inventors of NX-13 and first designed the small molecule to target NLRX1 in 2017. After discovery, the three accelerated the de-risking of NX-13 preclinically, including translational target engagement and multiple mouse models (published in the Journal of Immunology), and a novel proprietary pig model of IBD previously developed by Drs. Bassaganya-Riera and Hontecillas, following the same path that was used to develop omilancor. With this robust data package, the team opened INDs for NX-13 in UC and Crohn’s disease (CD) and successfully completed a Phase I study in normal healthy volunteers. Prior to their departure from Landos, Drs. Bassaganya-Riera, Hontecillas and Leber designed, initiated, and conducted a Phase Ib study in UC patients for NX-13, which has yielded the only clinical efficacy results released to the public to date.

In addition to Landos Biopharma, Dr. Bassaganya-Riera founded NImmune Biopharma (“NImmune”) with the purpose to advance the clinical development of the LANCL2 portfolio of immunoregulatory precision medicines. NImmune is led by Dr. Bassaganya-Riera as the Chief Executive Officer, Dr. Hontecillas as the Chief Scientific Officer, and Dr. Leber as the Chief Development Officer. In May 2023, the NIMML Institute executed a precision medicine research collaboration with NImmune to develop the LANCL2 portfolio of immunoregulatory therapeutics, including omilancor and NIM-1324, oral, once-daily agonistic therapeutics that bind and activate the LANCL2 pathway. Omilancor is currently in a global registration-directed Phase 3 program to treat UC. Final and complete Phase 2 data published on October 2023 at ACG showed that once daily omilancor induced a best-in-class remission rate of 30.4% in UC patients versus 3.7% in the placebo arm (P=0.01) with an unrivaled safety profile. NIM-1324 is anticipated to begin a Phase 2 program in Systemic Lupus Erythematosus (SLE) patients during 2H’24. NIM-1324 is also in clinical development for Rheumatoid Arthritis (RA) and other systemic autoimmune diseases. Both omilancor and NIM-1324 are guided by precision biomarkers discovered and developed by NIMML’s TITAN-X A.I.-powered Precision Medicine platform.

“Today’s transaction reinforces the novel immunoregulatory target discovery programs of the NIMML Institute, including LANCL2 and NLRX1, as well as the strong efficacy and safety profile of the innovative therapeutics we continue to develop at NImmune,” said Dr. Hontecillas, Co-Director and Chief Scientific Officer at NIMML. “The acquisition of NX-13 by one of the world’s leading biopharma companies signals continued momentum behind the important work we are doing to advance the development of effective treatments that can safely address the significant unmet clinical needs of millions of patients living with autoimmune diseases.”

Crucial to the development of NX-13, the NIMML team first characterized the key role of NLRX1 – a mitochondria-associated receptor involved in down-regulating inflammation – in the protection from IBD. NLRX1 modulates epithelial cell metabolism and the gut microbiota, which was demonstrated through seminal publications of immunology studies conducted by Dr. Bassaganya-Riera’s team, finding deficiency of NLRX1 worsens inflammatory responses in both CD4+ T cells and epithelial cells and shifts the metabolic preferences of cells. The NIMML team identified transdisciplinary mechanisms of NLRX1 anti-inflammatory effects whereby the regulation of lactate metabolism by NLRX1 aids in the prevention of effector T cell responses and the regulation of glutamine metabolism aids in the maintenance of epithelial barrier integrity. These immunometabolic findings laid the groundwork for Dr. Bassaganya-Riera’s team’s clinical development of NX-13 as a novel NLRX1 agonist oral therapy for the treatment of UC.

About Omilancor

By activating the LANCL2 pathway and modulating the interactions between immunological and metabolic signals in immune and epithelial cells, omilancor is a first-in-class, oral, once-daily, gut restricted therapeutic designed to create a favorable regulatory microenvironment in the gut, decreasing the production of key inflammatory mediators and increasing anti-inflammatory functions in regulatory T cells (Treg) within the site of inflammation. Omilancor has completed Phase 2 clinical testing in UC patients showing a clinical remission of 30.4% with a placebo-adjusted 12-week clinical remission rate of 26.7% (p=0.01) for the 440 mg dose. Following demonstration of a statistically significant approvable primary endpoint for clinical remission in an active disease patient population, Omilancor is currently in Phase 3 clinical testing for UC and Phase 2 clinical testing for CD.

About NIM-1324

NIM-1324 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. By activating the LANCL2 pathway, NIM-1324 increases the anti-inflammatory capacity and stability of regulatory CD4+ T cells while also supporting the metabolic demands of autophagy in phagocytes. To date, treatment with NIM-1324 has reduced the production of interferon alpha in human peripheral blood mononuclear cells (PBMCs) from systemic lupus erythematosus (SLE) patients and provided protection from clinical disease and tissue pathology in mouse models of lupus, rheumatoid arthritis, and multiple sclerosis. Phase 2-ready NIM-1324 completed Phase 1 clinical testing where it met all endpoints and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation.

About the TITAN-X Platform

The TITAN-X Precision Medicine Platform combines A.I. methodologies, bioinformatics, and advanced computational modeling to accelerate the development of precision medicines to address the unmet clinical needs of patients with autoimmune diseases. Building upon NIMML’s expertise in engineering large-scale computational models that study immunity as a massive and dynamically interacting system, the TITAN-X Platform integrates each step from new target discovery to enabling biomarker-driven precision clinical drug development. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, the TITAN-X Platform can identify transcriptional predictive signatures by using advanced A.I. algorithms. By analyzing gene expression patterns and integrating clinical data, the TITAN-X Platform can identify responder patterns, facilitating precision medicine approaches for drug development. This ensures that patients receive therapies that are most likely to benefit them according to their unique genetic signatures and clinical profiles, and that are tailored to maximize efficacy, safety, tolerability and minimize adverse side effects.

About NIMML

The NIMML Institute is a 501 (c) (3) non-profit foundation focused on applying transdisciplinary, team-science approaches to precision medicine. The NIMML Institute applies its TITAN-X advanced A.I.-powered platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. NIMML combines the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists to translate novel scientific discoveries into medicines for human diseases. The Institute is headquartered in Blacksburg, VA. For more information, please visit www.nimml.org or contact pio@nimml.org.

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