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TITAN-X AI Platform Accelerates Development of Novel Immunoregulatory Therapeutics for Autoimmune Diseases

• NIMML Institute and NImmune Biopharma have published case studies demonstrating how their TITAN-X AI platform has successfully identified novel therapeutic targets and accelerated drug development for inflammatory and autoimmune diseases.

• The platform has enabled the development of several clinical-stage therapeutics including omilancor for IBD (Phase 3), NIM-1324 for lupus and rheumatoid arthritis, and ABBV-113 (formerly NX-13) which was acquired by AbbVie in March 2024.

• By integrating AI, bioinformatics, and computational modeling, TITAN-X analyzes patient-specific gene expression patterns to develop biomarker-driven precision medicines, with an NDA for omilancor in ulcerative colitis planned by 2027.

The NIMML Institute and NImmune Biopharma have published four new case studies in the Annual Review of Biomedical Data Science showcasing how their AI-powered TITAN-X Precision Medicine Platform has revolutionized therapeutic development for inflammatory and autoimmune diseases.
The platform has successfully identified novel therapeutic targets and accelerated the development of multiple clinical-stage drug candidates, including several that have advanced to late-stage clinical trials.

AI-Driven Target Discovery and Drug Development

TITAN-X integrates artificial intelligence, bioinformatics, and advanced multi-scale modeling of immunometabolic mechanisms to identify and validate novel therapeutic targets. The platform has unlocked the therapeutic potential of previously unexplored immunometabolic targets such as LANCL2, LANCL3, NLRX1, IL-18, and PLXDC2.
Dr. Josep Bassaganya-Riera, Founding Director of NIMML and Founder & CEO of NImmune, emphasized the platform's impact: "These use cases provide several exciting and successful applications of our innovative TITAN-X platform in infectious, inflammatory and autoimmune diseases, highlighting our now clinically proven methods of leveraging large-scale datasets to advance immunological research and drug discovery."
The collaboration between NIMML, a 501(c)(3) nonprofit research institute, and NImmune Biopharma, a private biopharmaceutical company, has yielded an impressive pipeline of therapeutic candidates that are now in various stages of clinical development.

Clinical-Stage Therapeutics Emerging from the Platform

The TITAN-X platform has enabled the development of several promising therapeutics:
  • Omilancor: A first-in-class, oral, once-daily, gut-restricted therapeutic targeting LANCL2 for inflammatory bowel disease (IBD), currently in Phase 3 trials. Phase 2 data showed potential best-in-class efficacy and safety profiles. NImmune plans to file a New Drug Application (NDA) with the FDA for ulcerative colitis by 2027.
  • NIM-1324: In development for lupus, rheumatoid arthritis, and other inflammatory and autoimmune indications.
  • ABBV-113 (formerly NX-13): Recently acquired by AbbVie in March 2024, this therapeutic was also developed using the TITAN-X platform.

Precision Medicine Approach

What sets TITAN-X apart is its ability to analyze patient-specific data to develop precision medicines tailored to specific patient populations. The platform studies immunity as a dynamically interacting system interconnected with key metabolic processes.
"Data-driven and AI-powered approaches like the TITAN-X computational platform have already enhanced the pace of drug development, and we are eager to continue leveraging its capabilities to reduce costs, tailor treatments to specific patient populations, and increase the probability of success in clinical trials," Dr. Bassaganya-Riera noted.
Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, TITAN-X identifies transcriptional predictive signatures using proprietary AI algorithms. By analyzing both global gene expression patterns and metabolic profiles while integrating clinical data, the platform can identify responder patterns to facilitate precision medicine approaches.

Streamlining the Drug Development Process

The TITAN-X platform was carefully engineered to rapidly and efficiently integrate large-scale immunology datasets in drug discovery and development. It enables a seamless and cost-effective transition from early target discovery to clinical testing, launch, and commercialization of first-in-class therapeutics for inflammatory and autoimmune diseases.
This approach not only accelerates the pace of drug development but also increases the probability of success in clinical trials by ensuring that patients receive therapies most likely to benefit them according to their unique genetic signatures and clinical profiles.

Future Directions

With the success of its current pipeline, NImmune is positioned to continue developing novel biomarker-driven immunoregulatory therapeutics. The company's business model enables rapid and capital-efficient clinical development of high-conviction drug candidates from discovery through NDA filing and commercialization.
As the field of precision medicine continues to evolve, platforms like TITAN-X demonstrate how AI and computational modeling can transform the traditional drug development paradigm, potentially bringing much-needed therapies to patients with inflammatory and autoimmune diseases more quickly and efficiently than conventional approaches.
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