Dr. Josep Bassaganya-Riera is the founder and CEO of NImmune Biopharma, a late-stage biotech whose main assets are omilancor—a first-in-class Phase 3, once-daily, oral, gut-restricted therapeutic for ulcerative colitis with fast-to-market follow-on opportunities in Crohn’s disease and Psoriasis—and NIM-1324, a first- and best-in-class Phase 2-ready once-daily, oral, systemically distributed LANCL2 agonist therapeutic for the treatment of Systemic Lupus Erythematosus (SLE), rheumatoid arthritis and other indications.
He previously founded Landos Biopharma, Inc. (NASDAQ: LABP which was acquired by AbbVie in 2024) and served as Chairman, President and CEO for five years. Now at the helm of NImmune Biopharma, he champions strategic vision and operational leadership leading a seasoned leadership team with a successful track record in both private and public biotech.
In addition to Landos and NImmune, Dr. Bassaganya-Riera also founded NIMML and Biotherapeutics, as part of the thriving biohealth innovation ecosystem in Virginia. Across the ecosystem, he has raised over $250 million in non-dilutive and equity financing rounds and successfully negotiated strategic partnerships with a number of leading pharmaceutical partners. He has contributed over 200 patents in immunology and autoimmune disease treatment and published over 300 peer-reviewed articles, book chapters, and books on immunology, inflammation, the acceleration of biopharmaceutical development, and computational immunology.
Dr. Bassaganya-Riera has applied agile and lean management systems in combination with an efficient use of capital to catalyze value accrual and capture. He holds a degree in Veterinary Medicine from Universitat Autònoma de Barcelona and a Ph.D. in Nutrition and Immunology from Iowa State University. Prior to his time in the private sector, he served as Professor of Inflammation & Immunology at Virginia Tech, where he led a large-scale immunology research program.
Can you provide an overview of NImmune Biopharma? How is your work at NImmune different from what you set out to do at Landos?
In March 2024, Landos, a biopharmaceutical company I founded, led and built from the ground up, was acquired by AbbVie. Landos developed therapeutics for inflammatory bowel diseases (IBD), and AbbVie’s focus on Landos’ early stage drug candidate, NX-13 (now called ABBV-113), reflected an understanding that there is demand for safe and effective drugs targeting innovative mechanisms of action for inflammation and immunology (commonly called I&I) indications with unmet clinical needs.
Our team invented and developed NX-13 from inception to the clinical results that enabled the exit with Abbvie, and this gave us immense optimism for the assets we continue to develop today at NImmune Biopharma. Today, my team at NImmune—the very same original, proven and loyal leadership team from Landos— is continuing to progress novel best-in-class biomarker-driven immunoregulatory therapeutics to clinical testing and commercialization.
Underpinned by TITAN-X, an A.I.-powered computational platform, NImmune’s business model enables the rapid and capital-efficient clinical development of high conviction drug candidates into New Drug Application (NDA) filings with the FDA and commercialization.
Our goal at NImmune is to create the next wave of first-in-class and best-in-class precision medicines for autoimmune and inflammatory diseases with unmet clinical needs, starting with ulcerative colitis and Crohn’s disease, a $27 billion market that grows at 6% annually.
Can you overview some of the more notable product candidates within NImmune’s portfolio?
The lead product candidate from NImmune’s TITAN-X platform is omilancor, a wholly-owned Phase 3 oral, once-daily, gut-restricted, first-in-class immunometabolic therapeutic targeting LANCL2 for ulcerative colitis, with fast follower potential in Crohn’s disease, Psoriasis and other autoimmune diseases. Omilancor treatment creates 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, restoring Treg depletion and enhancing mitochondrial function typical of inflammatory bowel disease (IBD).
In short, we created omilancor to be a unique, best-in-class oral therapy that can break through the treatment ceiling in IBD, and we are excited by omilancor’s remarkable consistency across multiple clinical studies as a best-in-class efficacy with unrivaled safety and tolerability with no dose-limiting toxicities and a placebo-like safety profile.
Another notable clinical product candidate in NImmune’s extensive therapeutic pipeline is NIM-1324, an oral, systemically distributed, small-molecule therapeutic candidate for lupus, rheumatoid arthritis and other I&I indications. NIM-1324 activates LANCL2, a novel therapeutic target responsible for modulating key cellular and molecular changes tied to inflammatory and autoimmune diseases. To date, treatment with NIM-1324 has shown impressive efficacy and safety in systemic lupus erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, IBD and other I&I indications. NIM-1324 has successfully completed Phase 1 clinical testing where it met all endpoints of safety and tolerability, was validated to engage LANCL2 in humans based on a blood precision transcriptional signature and demonstrated a dose proportional change in plasma exposure within the therapeutic range with no accumulation.
Addressing the unmet clinical needs of patients has been incredibly motivating for the NImmune team, and the recent acquisitions have been validating for our longstanding vision in Biotherapeutics, Landos and NImmune. It reaffirms the tangible success of the therapeutic assets my team and I invested in, as well as those of TITAN-X, our advanced computational platform.
Could you explain the complimentary nature of the work between your foundation (NIMML) and NImmune?
I founded NIMML in 2002, and it is dedicated to combining advanced computational modeling using A.I. with translational research and clinical testing to characterize the underlying immunological mechanisms that fuel a wide range of infectious, inflammatory and immune-mediated diseases. NIMML applies its TITAN-X Precision Medicine A.I.-powered Platform to large-scale transdisciplinary projects aimed at solving important public health problems through precision medicine. By 2010, I secured a large-scale $12 million contract from the NIH to establish one of four Nationwide Centers of Modeling Immunity for Biodefense (MIB). The MIB program brought together some of the best minds in the nation–immunologists, computer scientists, data scientists, statisticians, and engineers—to develop advanced large-scale computational models of the gut immune system of unprecedented scalability for infectious diseases and biodefense. We also developed user-friendly tools for A.I. bioinformatics and modeling. This was 14 years before the current A.I. revolution, and it was the inspiration for engineering TITAN-X as a drug development platform for identifying new drug targets and creating the next wave of precision medicines.
A collaboration between NIMML and NImmune was announced in May of 2023, and has since strengthened 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. Through this strategic partnership with NIMML, NImmune has accelerated 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 of these novel treatments to specific patient populations.
An additional collaboration between Biotherapeutics and NImmune was announced in September of 2024. Through NImmune’s strategic partnerships with both the NIMML Institute and BioTherapeutics, we have created a best-in-class scientific ecosystem in the Commonwealth of Virginia capable of accelerating the pipeline—from A.I.-enabled target discovery and validation using the TITAN-X platform to preclinical animal modeling to clinical testing and ultimately commercialization. The regulatory infrastructure, preclinical resources, and leading proprietary models of disease and pathology developed and honed at BioTherapeutics allow us to focus NImmune’s organizational energy squarely on advancing clinical development of our immunoregulatory therapeutic pipeline. The collaboration between NIMML, Biotherapeutics, and NImmune has allowed us to significantly accelerate the development of novel precision medicines for inflammatory and autoimmune diseases.
How is NImmune leveraging AI in drug development?
At NImmune, we create computer models, provide clinical and translational data, and in collaboration with NIMML, leverage our AI-powered TITAN-X platform to drive our precision I&I drug development. TITAN-X is a proprietary precision medicine platform that has shown it can accelerate the development of novel I&I therapeutics.
Data-driven and A.I.-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, starting with NImmune’s LANCL2 therapeutic pipeline. For instance, TITAN-X computational power can inherently reduce costs, enhance clinical success rates, and identify biomarker signatures that predict treatment responses in ulcerative colitis and Crohn’s disease, aiding in patient selection, reducing clinical and regulatory timelines, lowering costs, de-risking product candidate and ultimately accelerating the commercialization of First-in-Class or Best-in-Class drugs for inflammatory and autoimmune diseases.
Building on our pioneering work under MIB, the TITAN-X Precision Medicine A.I. Platform is designed to study immunity as a massively and dynamically interacting system that is intimately interconnected with key metabolic processes. TITAN-X combines advanced computational modeling, bioinformatics tools and A.I., including mechanistic models of CD4+ T cell activation and differentiation, multiscale models of gut mucosal immune responses, modeling pipelines with integrated machine learning tools, and advanced data analytics and visualization, plus bioinformatics pipelines, including the Modeling Metabolism (M2) module which provide new insights on immunometabolic interactions. Following bioinformatic analysis of differentially expressed genes from patient biopsy specimens, TITAN-X can identify transcriptional predictive signatures using its proprietary A.I. algorithms. By analyzing both global gene expression patterns and metabolic profiles while integrating clinical data, TITAN-X can identify responder patterns to facilitate precision medicine approaches for drug development, ensuring that patients receive the best therapies that are most likely to benefit them according to their unique profiles.
In the case of NImmune, we have already utilized TITAN-X to develop an expansible pipeline of therapeutics for I&I, including two lead therapeutic assets. TITAN-X has been deployed to identify novel therapeutic targets to support the development of late clinical stage biomarker-driven immunoregulatory therapeutics such as omilancor for IBD and NIM-1324 for lupus, rheumatoid arthritis, and a wide range of other I&I indications. TITAN-X also shaped the development of NX-13, which was acquired by Abbvie in March 2024 and is now called ABBV-113, as well as multiple additional novel MoA targets and drug candidates for I&I indications.
What biotech trends are currently impacting NImmune and your work at NIMML?
The A.I. revolution is shaping numerous facets of our lives, but the overall impact of advanced computational methods in biopharma has been largely underreported. On the front lines of drug development, the combination of A.I. with computational modelling and bioinformatics has become fundamental for the advancement of drug development research we have seen over the last decade.
At NImmune, we have already utilized TITAN-X to develop an expansible pipeline of therapeutics for I&I, including multiple lead clinical therapeutic assets. As we continue to innovate and harness the power of A.I. in I&I research and discovery, we are encouraged by the clear successes and validations in the market. The influx of capital and talent into A.I., coupled with its scalability, has already yielded substantial returns for us at NImmune.
Importantly, A.I. is a tool to make drug discovery cheaper, faster, and better. A.I. is not a replacement for human ingenuity. Accordingly, we will continue to leverage A.I. and advanced computational modeling to push the boundaries of what is possible in I&I drug development. We remain committed to continuing to grow the TITAN-X Platform‘s capabilities to address a broader range of I&I diseases, including lupus, psoriasis, atopic dermatitis, asthma, multiple sclerosis, diabetes, and Alzheimer disease, and continually refine our models, clinical datasets and predictive algorithms to enhance patient stratification and therapeutic outcomes.
What is next for NImmune?
Many of our product candidates at NImmune are positioned to continue moving through development phases, with the goal of bringing effective and proven novel therapeutics to the market. At NImmune, we carefully analyze where we will invest our capital and research as we seek to introduce new therapeutics which can deliver relief for millions of patients with unmet clinical needs.
Currently, our lead product candidate in Phase 3 clinical development is omilancor, which has now shown it can be a safe and effective treatment from mild and moderate patients with active disease to even in very severe cases when patients are resistant to other therapy options. Results across several clinical trials demonstrate omilancor’s commercial path to ulcerative colitis and Crohn’s disease patients, affirm ongoing plans to complete Phase 3 development of omilancor in ulcerative colitis and initiate the New Drug Application (NDA) to the U.S. FDA by 2027 with additional NDAs soon thereafter. We will continue to progress our research in omilancor and other product candidates in our innovative pipeline and strive to rapidly deliver safe and effective therapeutics to the public.
There remains a significant unmet clinical need for novel treatments that can induce and maintain significant improvements in clinical remission and break through the efficacy ceiling of current therapies. NImmune is currently evaluating combination therapies that can accomplish that goal. For instance, while omilancor outperforms the efficacy of anti-TL1A antibodies with a superior safety profile and a once daily oral dosing, two recent head-to-head studies highlight the complementarity of LANCL2 and anti-TL1A novel mechanisms of action in treating IBD.
TITAN-X can identify transcriptional predictive signatures for precision medicine applications by using its proprietary A.I. algorithms. By analyzing both global gene expression patterns and metabolic profiles while integrating clinical data, TITAN-X can identify responder patterns to facilitate precision medicine approaches for drug development, ensuring that patients receive the best therapies that are most likely to benefit them according to their unique profiles. By using TITAN-X, we have identified a transcriptional signature that enables us to predict omilancor responders and non-responders based on baseline data. Our conservative estimates indicate that this precision medicine approach could double the efficacy of omilancor.
Can you overview your recent foray into thoroughbred breeding in the Mid-Atlantic region?
In 2021, through Covilar LLC, I acquired Owl Hollow Farm in Floyd, Virginia, a 120-acre equestrian estate formerly owned by Steve McBroom, who was widely regarded as the champion of the Virginia horse industry, with the intention to strengthen premier horse breeding to the mid-Atlantic region. Last year, Covilar LLC also became co-owner of Five Star General (“Ike”), a graded stakes winner race horse of superior pedigree, who has recently started his stud career at Owl Hollow Farm. Ike has amassed race career earnings of $902,202, highlighted by victories in the Grade 3 British Columbia Derby at Hastings and back-to-back wins in the Longacres Mile, demonstrating his resilience and competitive spirit. In 2024 alone, he earned $224,773 and secured a 33%-win rate, with an impressive 72% top-three finish rate across all races. His career-best equibase speed figure of 114, competitive spirit and adaptability underscore his quality as both a racehorse and a top-quality stallion.
Establishing Covilar’s Owl Hollow Farms elite thoroughbred breeding program combines my background in veterinary medicine with my interest in genetics, breeding and racing, all of which have also informed my career-long interest in biopharma research and development. At Covilar’s Owl Hollow Farm, we carefully consider the genetic pairings which will produce the next generation of racehorses and evaluate a variety of biological variables, stamina, resilience, speed, and other phenotypes which indicate the optimal combinations.
There are many similarities between my work as a biotech executive in NImmune, Biotherapeutics and Landos and my foray into thoroughbred breeding at Owl Hollow Farm. Success in either domain requires a high level of dedication, persistence, and shared vision between many collaborators. My pursuits in research and biopharma all required bold vision and unwavering commitment to developing safer and more effective drug candidates and would not have been possible without the combined efforts of a team of collaborators. Success in horse racing requires this exact kind of commitment, and outstanding operational execution hinges on the shared vision and collaboration between trainer, jockey, and owner – just as scientific progress requires a strong team of specialized principals. Both fields require the ability to take calculated risks, and the same entrepreneurial spirit that has driven my success in drug discovery and development is what I seek to bring to Covilar Farms.
Through this program, we seek to build support for thoroughbred horse breeding and racing in the mid-Atlantic, a region with rich history including the home of legendary Secretariat but that has long been overlooked. With the success of Ike, who already has several foals on the way, we seek to bring optimal genetics to the East Coast and create a winning legacy for generations to come. We are expecting the first crop of Virginia-bred foals from Ike’s breeding’s in early 2026.
