Inside NImmune’s Phase 3 Push in Ulcerative Colitis
Founder Josep Bassaganya-Riera on omilancor, a gut-restricted oral therapy, precision biomarkers in inflammatory bowel disease, and the TITAN-X AI platform.
In this week’s podcast episode of Biotech Blueprint, I sat down with Dr. Josep Bassaganya-Riera, founder and CEO of NImmune Biopharma, to talk about what it takes to build a late stage immunology company in 2025: navigating a tighter capital environment, designing Phase 3 programs that meet today’s regulatory expectations, and using AI in ways that actually change decisions.
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Josep has built multiple companies at the intersection of immunology and computational modeling, including leading the Landos Biopharma team that advanced oral immunometabolism drugs into the clinic and ultimately sold an asset to AbbVie. His newest company, NImmune, is built around omilancor, a once-daily, oral, gut-restricted LANCL2 agonist now in Phase 3 for ulcerative colitis, paired with TITAN-X, a computational modeling platform shaped by two decades of work in immune system simulation.
What stood out in our conversation is not reinvention, but continuity: the same scientific logic, adapted for a harsher funding climate and executed with a more focused clinical strategy.
The “reverse” spin-out
At Landos, Josep and his team pursued oral immunometabolism drugs, aiming to recalibrate immune cell function by altering their underlying energy pathways. One of these was NX-13, an oral NLRX1 agonist that ultimately became the centerpiece of the deal with AbbVie.
Normally, when Big Pharma buys a biotech, that’s the end of the story. The pipeline gets absorbed and the founder moves on. In this case, the sequence was flipped. By the time AbbVie acquired Landos, the LANCL2 programs (including omilancor) had already been transferred back to Josep, and he built NImmune around those assets with much of the same team from Landos.
The result is a rarity in 2025: a private company launching with a Phase 3-ready asset in ulcerative colitis and Phase 2 in Crohn’s disease, bypassing many of the usual hurdles that come with starting over.
LANCL2: A thermostat, not a sledgehammer
The current standard of care in inflammatory bowel disease (IBD), including biologics and JAK inhibitors, can often act as an immunological sledgehammers. They broadly suppress inflammation, which works for a time but often leads to waning efficacy and significant safety trade-offs (like black box warnings for infections and malignancy).
NImmune’s lead candidate, omilancor, functions more like a thermostat. It is a once-daily, gut-restricted small molecule that targets LANCL2.
LANCL2 is expressed on multiple cell types in the gut, including regulatory T cells, effector T cells, macrophages, and epithelial cells. When LANCL2 is activated, immune cells shift toward mitochondrial metabolism rather than glycolysis. The details are biochemical, but the effect is intuitive: cells become more regulatory and less inflammatory.
In diseases like ulcerative colitis and Crohn’s, regulatory T cells are often dysfunctional, and inflammatory pathways dominate. Omilancor aims to rebalance the immune response rather than broadly suppress it, and because the drug is gut-restricted, early studies suggest a notably clean systemic safety profile.
A Phase 3 trial will test whether that promise holds at scale.
From 1 in 5 to 1 in 3: the biomarker ambition
A major theme of the conversation was precision. NImmune has developed a gene expression signature designed to identify patients most likely to respond to omilancor.
Josep contrasted this with the real world performance of many advanced IBD therapies, which often help about 20% of patients outside the trial setting.
NImmune’s ambition is 1 in 3 response in an unselected population and approaching 1 in 2 with biomarker-guided selection. If validated prospectively, this biomarker strategy could shift omilancor’s positioning from “another oral therapy” to a targeted, early line option.
TITAN-X: predictive modeling, not retrospective storytelling
In a market saturated with AI hype, NImmune’s TITAN-X platform distinguishes itself by its lineage. The platform grew from a multi-million dollar NIH funded effort to computationally model immune responses for biodefense. It combines mechanistic immune simulations, bioinformatics, and machine learning.
Josep emphasized that the platform is used for prospective validation, making a prediction and then physically testing it, to avoid “retrospective storytelling”. According to NImmune, the platform helped identify the gene signature they believe may predict response with 83% accuracy. As mentioned previously, standard IBD drugs work in roughly 1 in 5 patients, NImmune projects omilancor could work in 1 in 2 patients if using the biomarker.
TITAN-X predictions are treated as hypotheses - tested, corrected, and fed back into the system. Over years, this has guided decisions on dose, patient subset identification, trial site strategy, and even target prioritization.
Why this matters
Oral IBD therapies have historically faced a tradeoff: safe but modest, or potent but systemically risky. If omilancor can reproduce its Phase 2 efficacy, maintain a clean safety profile, and validate its biomarker strategy, it could redefine expectations for oral immunology.
For a field dominated by powerful biologics and systemic small molecules, omilancor poses a simple question: What if the fastest way to control inflammation is to restore the gut’s natural braking systems rather than suppress immunity broadly?
Building in a new era
Capital is tighter, timelines are scrutinized, and the tolerance for meandering clinical programs is low. NImmune has engineered its approach around that reality: a well-understood mechanism, a defined biomarker hypothesis, and a team that has lived with this biology across multiple cycles.
Whether omilancor succeeds in Phase 3 will ultimately depend on the data. But if the pivotal results mirror early signals, omilancor could offer more than another oral option. It would test whether immune rebalancing approaches, paired with smarter patient selection, can meaningfully expand how we treat IBD.
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Solid walkthrough of omilancor's immunometabolic angle. The "thermostat vs sledgehammer" framing is spot-on because most IBD therapies just supress everything broadly. But that 1 in 2 biomarker-guided efficacy claim really hinges on prospective vaildation, without that it's just another nice Phase 2 story.