NLRX1

Pictured: AbbVie's headquarters in California/iStock, Michael Vi AbbVie on Thursday announced that it has bought Cambridge, Massachusetts-based startup Celsius Therapeutics and its lead inflammatory bowel disease antibody CEL383. Details of the acquisition agreement were sparse, with the companies only revealing that AbbVie will snap up all of Celsius’ remaining equity for $250 million in cash, subject to certain adjustments. The companies have not yet announced when they plan to close the transaction. “We are eager the advance the development of CEL383 with a goal of helping more patients with [inflammatory bowel disease (IBD)] achieve remission,” Kori Wallace, global head of immunology clinical development at AbbVie, said in a statement. Developed using Celsius’ proprietary SCOPE platform, which allows the startup to “understand the cells that drive disease progression,” CEL383 is a potentially first-in-class monoclonal antibody that works by targeting the TREM1 protein. TREM1 mediates the interaction between the microbiome and the immune system while amplifying mucosal inflammation, according to the biotech’s website. Preclinical studies have validated this mechanism of action, showing that CEL383 could disrupt TREM1 signaling and lowering the concentration of several inflammatory mediators. CEL383 has recently completed a first-in-human, placebo-controlled, single-ascending-dose Phase I trial in healthy volunteers, designed to evaluate its safety, tolerability and pharmacokinetic profile. Thursday’s acquisition of Celsius is part of AbbVie’s strategy to deepen its portfolio as it weathers a particularly steep patent cliff for its blockbuster immuno therapy Humira (adalimumab). Since losing its most important patent protections, Humira has mostly retained market dominance despite the flurry of biosimilars that flooded the U.S. market. However, in April 2024, fueled by CVS Caremark delisting Humira from its major national commercial formularies, copycats have enjoyed a surge in demand and sales. To shore up its revenues and target future growth, AbbVie has been striking a series of deals giving it access to promising assets and technologies. In February 2024, the pharma put $713 million on the line for an exclusive right to develop, manufacture and commercialize OSE Immunotherapeutics’ investigational antibody OSE-230, being assessed for chronic and severe inflammation. Soon after, AbbVie dropped $212 million to acquire Landos Biopharma gaining access to the oral NLRX1 agonist NX-13, which is being studied as a treatment for ulcerative colitis and Crohn’s disease. AbbVie has joined a recent biopharma spending spree in the projected $257 billion immunology market. Outside the immuno space, AbbVie has also invested heavily in the mental health market entering a potential $2 billion deal with Gilgamesh Pharmaceuticals in May 2024 to develop neuroplastogens for psychiatric disorders. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

- Adds first-in-class investigational asset, NX-13, to AbbVie's pipeline with the potential to offer a novel approach to the treatment of ulcerative colitis (UC) and Crohn's disease (CD) NORTH CHICAGO, Ill., May 23, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that it has completed its acquisition of Landos Biopharma, Inc. (NASDAQ: LABP). With the completion of the acquisition, Landos is now part of AbbVie. Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family), which is currently in Phase 2 for the treatment of moderate to severe UC (NEXUS study; NCT05785715). NLRX1 regulates immunometabolism and inflammation, and its activation may address inflammatory bowel disease (IBD) pathogenesis. With a dual mechanism of action that is anti-inflammatory and facilitates epithelial repair, NX-13 has the potential to offer a novel approach to the treatment of UC and CD. "Many people living with IBD are not able to achieve or maintain remission and continue to experience debilitating symptoms," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "The addition of NX-13 complements our portfolio in immunology and strengthens our collective efforts to transform standard of care. I want to commend the Landos team for their efforts in advancing our shared mission of developing medicines for those who need it most." For additional background on the acquisition, please read the announcement press release here. Financial Terms AbbVie has acquired Landos at a price of $20.42 per share, plus one non-tradable contingent value right per share with a value of up to $11.14 per share, subject to the achievement of a clinical development milestone. Landos' common stock will cease to trade on the NASDAQ stock exchange prior to market open on May 24, 2024. About the NEXUS Study NEXUS is a Phase 2 proof-of-concept clinical trial evaluating NX-13 in patients with moderate to severe UC. NEXUS is a randomized, multicenter, double-blind, placebo-controlled, multiple dose, 12-week induction study evaluating 80 patients with moderate to severe UC with a long-term extension (LTE) period. All subjects will be randomized to receive either 250 mg or 750 mg immediate release NX-13, or placebo. The primary objective of the trial will be to evaluate clinical efficacy, safety and pharmacokinetics of oral NX-13 versus placebo (NCT05785715 ClinicalTrials.gov). About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. Forward looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward looking statements, and AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie

Pictured: False-colored image of AbbVie headquarters building/Taylor Tieden for BioSpace On Monday, AbbVie agreed to acquire Landos Biopharma and its lead clinical candidate NX-13, a first in class once daily oral NLRX1 agonist, currently in Phase II clinical development for ulcerative colitis. I founded Landos in 2017 and it’s validating to see this tangible success of the assets my team and I invented, as well as the advanced computational platform I helped engineer. More broadly, this transaction is the latest to highlight Big Pharma’s growing interest in developing novel targets for inflammation and immunology (I&I) treatments, as well as the potential for cutting-edge computational drug development. AbbVie, the maker of Humira, is among the world’s largest biopharmaceutical companies in part because of Humira’s commercial success, which underpins its multi-billion-dollar I&I portfolio. But its acquisition of NX-13 reflects an understanding that the market is ready for new options, particulary drugs that employ novel mechanisms of action (MoAs). Another example of a transaction involving a novel MoA in IBD is Roche’s $7.1 billion acquisition of Telavant Holdings, a vehicle in which Roivant and Pfizer have placed the rights to develop, manufacture and commercialize the experimental IBD drug known as RVT-3101 in the United States and Japan. Meanwhile, Merck’s $10.8 billion acquisition of Prometheus last year encompassed not only a leading novel therapeutic clinical candidate (PRA-023/MK-7240) for ulcerative colitis (UC) and another type of IBD, Crohn’s disease (CD), but also the advanced computational engine that supported its development—clearly a driver of the premium price Merck paid for these assets. Under the terms of this week’s agreement, AbbVie acquired some of Landos’ early-stage assets in addition to NX-13. But the pharma giant did not get the TITAN-X Drug Development Platform, the advanced computational system that first characterized and validated the therapeutic targets for NX-13 and omilancor. This proprietary computational engine for precision medicine is still owned and operated through NIMML Institute, a 501 (c)(3) nonprofit institute I founded to study the immune system. Because I, like the Big Pharma companies, recognize that drugs with novel MoA have the potential to become best-in-class or first-in-class therapeutics with enhanced market penetration and greater revenue generation in a multi-billion-dollar market. The Original Landos Team and I Are Still At It I left Landos in November of 2021 when its market capitalization was ~$600 million to start NImmune, a late-clinical-stage precision immunology biopharmaceutical company. My goal was to apply NIMML’s technology to create the next wave of biomarker-driven immunoregulatory therapeutics for precision medicine. In 2023, NImmune re-acquired the late-stage clinical assets we created from the ground up at Landos such as omilancor, currently in Phase III clinical development for UC and Phase II trials for CD, and NIM-1324, Phase II–ready for lupus and rheumatoid arthritis. I and the original executive leading the Series A, B and IPO financings, along with the R&D teams that created the Landos therapeutic pipeline, continue to collaborate on the next wave of precision medicine drugs at NImmune, and there are several strong tailwinds at our backs. The space is exploding, and for good reason. IBD afflicts more than 3 million people in the U.S. and 5 million people globally, with a prevalence increasing more than 5% per year. Existing treatments for IBD prove ineffective for the long-term management of the disease in most patients. There is an urgent unmet medical need for oral therapies that target new MoAs. Increasingly, the discovery of new MoAs and the clinical drug development process are being optimized by A.I.-powered platforms with advanced computational modeling, data analytics and bioinformatics capabilities. In our case, the TITAN-X precision medicine platform characterizes novel therapeutic targets and identifies novel transcriptional signatures that accurately predict responses to treatment in UC and CD, inform patient selection, reduce development timelines, lower costs and improve probability of success in the clinic. In similar action to our TITAN-X precision medicine platform, the Prometheus360 platform was used to discover novel therapeutic candidates, inform patient selection and increase efficacy. While many have described M&A as a stagnant market for biopharma, there are encouraging signs that this is no longer the case for I&I therapeutics—and novel immunoregulatory drug candidates are being advanced through the pipeline that could one day improve the lives of millions of patients living with inflammatory and autoimmune diseases. I believe AbbVie’s recent acquisition of my former company emphasizes the real potential (and value) of advanced computational drug development technology that enables innovative developers to rapidly and cost-effectively target and characterize new MoAs and create safer and more effective therapies. I am quite proud of our team for the integral role we played in AbbVie’s acquisition of NX-13 and Landos’ other early-stage assets and look forward to continuing on the accelerated path to cures mission that we first set out upon in 2017. This transaction signals continued momentum for innovative drug developers, the potential of A.I.-powered advanced computational platforms like TITAN-X and hope for the broader I&I pipeline of next-generation precision medicines in inflammatory and autoimmune diseases. Josep Bassaganya-Riera is the founder and former chairman, president and CEO of Landos Biopharma. He is the founder, executive chairman, president and CEO of NImmune Biopharma and president and CEO of the nonprofit NIMML Institute. Both organizations are devoted to the advancement of precision medicines for inflammatory and autoimmune diseases.