NImmune Biopharma Announces Precision Medicine Research Collaboration with NIMML Institute to Advance the Clinical Development of its LANCL Immunoregulatory Therapeutic Pipeline

Provides NImmune access to NIMML’s TITAN-X advanced computational modeling and A.I. platform to accelerate biomarker-driven clinical development of its LANCL immunoregulatory drug pipeline

NImmune will commit up to $15 million in R&D funding for the precision medicine collaboration with NIMML for advancing the LANCL drug pipeline

NImmune Biopharma ("NImmune”), a late-clinical-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics, today announced the launch of a research collaboration with the NIMML Institute (“NIMML”), a nonprofit institute dedicated to the discovery of novel immune-mediated precision medicines. The collaboration strengthens NImmune’s precision immunology capabilities by providing access to NIMML’s TITAN-X advanced computational modeling and A.I. platform for biomarker-driven clinical development. NImmune will also gain access to NIMML’s preclinical, translational, and clinical R&D and regulatory infrastructure.

Dr. David Moore, a NIMML Institute Board member and professor emeritus at Virginia Tech, stated, “The Institute welcomes this alliance with NImmune, whose interests and goals closely align with ours. The synergies gained from this collaboration will advance our mission to further understand the underlying immunological mechanisms that fuel a range of autoimmune diseases and help develop safer and more effective therapeutics.”

"Our collaboration with the NIMML Institute is a natural extension of NImmune's research and development strategy to create safer and more effective immunoregulatory therapeutics that address the unmet clinical needs of patients with autoimmune diseases,” said Dr. Josep Bassaganya-Riera, Founder & CEO of NImmune. “Our team has already identified novel gene expression signatures that predict the response to treatment for Phase 3-ready omilancor in ulcerative colitis and Phase 2-ready NIM-1324 in lupus. Through our strategic partnership with NIMML, we plan to accelerate the clinical testing and validation of therapeutically relevant gene clusters as biomarkers of response to treatment for omilancor and NIM-1324 in blood and tissue biopsies to determine which patients are most likely to benefit from the LANCL medications and, just as importantly, which are not."

Under the terms of the agreement, NIMML will utilize its proprietary TITAN-X drug development platform as well as its industry-leading advanced computational modeling, A.I., and bioinformatics capabilities to implement biomarker-driven approaches in NImmune’s upcoming clinical trials involving the company’s clinical LANCL therapeutics. NIMML will receive up to $15 million in research and development funding from NImmune for costs associated with the precision medicine collaboration. NImmune will be solely responsible for the further development and commercialization of any biomarker-driven therapeutics that are being developed using NIMML’s TITAN-X platform. As part of the strategic relationship, the NIMML Institute will be eligible to receive future payments in regulatory and commercial milestones, as well as tiered single-digit royalties on global product sales for NImmune’s therapeutic pipeline.

“This agreement significantly strengthens NImmune’s precision immunology capabilities,” continued Dr. Bassaganya-Riera. “We’re proud to enter this strategic partnership with NIMML, which combines the Institute’s advanced computational platform with our expertise in rapidly translating fundamental scientific discoveries in immunology into safer and more effective medicines for patients with autoimmune diseases such as ulcerative colitis, Crohn’s disease, psoriasis, rheumatoid arthritis, and systemic lupus erythematosus. We look forward to working with NIMML to accelerate the clinical development of our high-conviction drug candidates by applying precision medicine approaches.”

About NImmune Biopharma

NImmune is a late-stage precision immunology biopharmaceutical company that develops novel best-in-class biomarker-driven immunoregulatory therapeutics. Underpinned by a discovery platform that utilizes advanced computational modeling, A.I. and bioinformatics coupled with biomedical research capabilities to pioneer innovation in immunoregulatory drug development, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filing and commercialization. The lead product candidate from NImmune’s discovery platform is omilancor, a wholly-owned Phase 3-ready oral, once-daily, gut-restricted, first-in-class therapeutic targeting LANCL2 for Ulcerative Colitis and Crohn’s disease with registration-directed pivotal clinical trials planned for 2H’23. Phase 2 proof-of-concept data for omilancor show potential best in class efficacy and safety. For more information, please visit www.NIMMUNEBIO.COM or contact media@nimmunebio.com.

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 team leads numerous large-scale transdisciplinary projects and is dedicated to solving important societal problems through precision medicine by combining the expertise of immunologists, computational biologists, toxicologists, computational modelers, translational and clinical researchers, and molecular biologists. The Institute is headquartered in Blacksburg, VA. For more information, please visit www.nimml.org or contact pio@nimml.org.

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