Newly-Launched NImmune Biopharma Strikes Precision Medicine Collaboration with NIMML Institute to Advance Immunoregulatory Therapeutic Pipeline
By Alex Keown
May 9, 2023
NImmune Biopharma strengthened its precision immunology capabilities through a newly-forged research collaboration with the non-profit NIMML Institute in order to advance clinical development of its LANCL immunoregulatory therapeutic pipeline.
Blacksburg-based NImmune launched in March following a spin out from the NIMML Institute. The company hit the ground with a Phase III-ready experimental therapeutic for ulcerative colitis. The newly-minted collaboration will provide NImmune with access to NIMML’s TITAN-X advanced computational modeling and A.I. platform, which will be used for biomarker-driven clinical development. Additionally, NImmune gains access to NIMML’s preclinical, translational, and clinical R&D and regulatory infrastructure.
Under terms of the newly-forged collaboration, NIMML will use its TITAN-X drug development platform as well as its industry-leading advanced computational modeling, A.I., and bioinformatics capabilities in order to implement biomarker-driven approaches in NImmune’s upcoming clinical trials involving the LANCL assets. NImmune will be responsible for further development and commercialization of any biomarker-driven therapeutics being developed with NIMML’s TITAN-X platform.
NImmune provided the NIMML Institute with $15 million in research and development funding. The institute will be eligible for future regulatory and commercial milestones, as well as single-digit royalties on potential sales of NImmune therapeutic products.
Josep Bassaganya-Riera, who founded both NImmune and the NIMML Institute, said the collaboration is a natural extension of NImmune’s strategy to develop safe and effective immunoregulatory therapeutics for patients suffering from autoimmune diseases. He told BioBuzz the partnership with NIMML strengthens the company’s precision immunology capabilities and is a “clear step forward in rapidly accelerating our clinical development.”
“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,” Bassaganya-Riera said.
Since NImmune’s launch two months ago, Bassaganya-Riera said the company has been active establishing an “exceptionally experienced team that built the LANCL pipeline from the ground up.” The team is now focused on the next operational steps for advancing the company’s pipeline, including its Phase III-ready lead drug candidate, omilancor.
NImmune’s lead asset is omilancor, which the company secured in February 2023 from Landos Biopharma, a company Bassaganya-Riera founded in 2017. Bassaganya-Riera said the NImmune team identified novel gene expression signatures that predict the response to treatment with omilancor in ulcerative colitis patients. In a Phase II study, omilancor demonstrated biologic-like efficacy with potentially best-in-class safety. An analysis of that data showed treatment with the 440 mg dose generated a 30% clinical remission after 12 weeks in UC patients, which was statistically significant.
In addition to omilancor, NImmune gained the rights to Landos’ LANCL portfolio of immunoregulatory therapeutic assets, which also includes assets previously known as LABP-104 and now NIM-1324, and LABP-111, now NIM-5834, which are designed to activate the Lanthionine Synthetase C-Like 2 (LANCL2) pathway. Those gene expression signatures that predict response to omilancor is also being seen in NIM-1324, a potential treatment for Lupus, Bassaganya-Riera said. NIM-1324 has demonstrated the ability to induce enhanced regulatory Treg function in preclinical models of both systemic lupus erythematosus and rheumatoid arthritis.
NIM-5834 will be developed for type 1 diabetes and nonalcoholic steatohepatitis (NASH, a fatty liver disease.
“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,” he added. “We are pleased to be able to leverage our combined clinical and advanced computational expertise to develop best-in-class biomarker-driven immunoregulatory therapeutics for patients with autoimmune diseases.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
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