Landos Biopharma and LianBio Announce Exclusive Collaboration and Licensing Agreement for Omilancor and NX-13 in Greater China and Select Asian Markets

Blacksburg, Virginia (USA), Shanghai (China), and Princeton, New Jersey (USA), May 17, 2021 — Landos Biopharma, Inc. (Nasdaq: LABP), a clinical-stage biopharmaceutical company focused on developing therapies for patients with autoimmune diseases, and LianBio, a biopharmaceutical company dedicated to bringing transformative medicines to patients in China and other key markets in Asia, today announced that they have entered into an exclusive collaboration and license agreement. The two companies will jointly develop and commercialize the novel drug candidates Omilancor (BT-11) and NX-13 in Greater China (Mainland China, as well as Hong Kong, Macao, and Taiwan regions) and specific Asian markets. Omilancor is an investigational novel oral gut-restricted LANCL2 pathway agonist for the treatment of ulcerative colitis (UC), Crohn’s disease (CD), and eosinophilic esophagitis (EoE). NX-13 is another investigational novel oral gut-restricted therapeutic agent targeting the NLRX1 pathway for the treatment of ulcerative colitis and Crohn’s disease.

“As our company plans to expand its innovative autoimmune disease product pipeline into global development, we are delighted to partner with LianTuo Bio, strategically integrating its clinical and operational strengths in key Asian markets.”Josep Bassaganya-Riera, Chairman, President, and Chief Executive Officer of Landosstated, “Compared with currently available therapies, our two lead candidate products, omilancor and NX-13, offer core advantages, including the ability to target key novel pathways associated with immune function. This collaboration provides us with the opportunity to leverage LianTuo Bio’s resource network in Asia, thereby fully realizing the global value of our products and delivering our potentially more effective and better-tolerated, first-in-class oral novel therapeutics to patients with ulcerative colitis and Crohn’s disease in Greater China and select Asian markets.”

Under the terms of the collaboration, LianTuo Bio will obtain exclusive rights to develop and commercialize omilancor and NX-13 in Greater China, South Korea, Singapore, Thailand, Vietnam, Myanmar, Cambodia, Indonesia, and the Philippines; Landos will receive an upfront payment of $18 million and is eligible to receive up to $200 million in development and commercialization milestone payments. Landos is also entitled to low double-digit tiered royalties on net sales of omilancor and NX-13 within the licensed territories. LianTuo Bio will participate in the global Phase III clinical trials of omilancor and NX-13 by enrolling a specified number of patients in relevant studies. All development and commercialization costs within the collaboration territories will be borne by LianTuo Bio, while costs outside these territories will be covered by Landos.

“Landos has demonstrated strong capabilities in exploring and developing first-in-class oral novel drugs targeting novel immuno-metabolic pathways. Based on this, we believe Landos is well-positioned to pioneer a new therapeutic paradigm for autoimmune diseases such as ulcerative colitis and Crohn’s disease.”Konstantin Poukalov, Managing Director at Perceptive Advisors and Executive Chairman of LianTuo Biostated, “The incidence of inflammatory bowel disease (IBD) in Asia is projected to rise significantly over the next decade. Through our collaboration with Landos, we are committed to addressing the treatment needs of both current and future IBD patients.”

Landos Biopharma is a clinical-stage biopharmaceutical company focused on developing novel oral therapeutics for patients with autoimmune diseases by leveraging its LANCE artificial intelligence platform. Based on the LANCE AI platform, the company has identified multiple immunometabolic mechanisms, including pathways involving LANCL2, NLRX1, and PLXDC2. Landos Biopharma currently has 17 ongoing research programs targeting nodes within these immunometabolic pathways. Its lead candidate, omilancor, is a novel gut-restricted small molecule drug that targets the LANCL2 pathway for the treatment of ulcerative colitis (UC), Crohn’s disease (CD), and eosinophilic esophagitis (EoE). NX-13 is another novel gut-restricted small molecule drug that targets the NLRX1 pathway for the treatment of inflammatory bowel disease (IBD). Additionally, candidate drugs for the treatment of lupus nephritis (LN), rheumatoid arthritis (RA), multiple sclerosis (MS), and diabetes are also under development.

LianBio’s mission is to deliver optimal science-driven breakthrough therapies to patients in China and other key Asian markets through efficient product development, enabled by strategic partnerships with leading global biopharmaceutical companies. By collaborating with world-class partners across diverse therapeutic areas and geographies, LianBio has built a disease-relevant product pipeline and leverages translational mechanisms and precision therapies to improve patient outcomes.

Omilancor is a novel, investigational gut-restricted small molecule discovered through Landos’ LANCE artificial intelligence platform. It targets the LANCL2 (Lanthionine Synthetase C-Like 2) pathway, which influences the gastrointestinal tract. LANCL2 plays a significant role in immune regulation. By activating the LANCL2 pathway and modulating the interplay between immune and metabolic signaling in immune cells, omilancor creates a favorable regulatory microenvironment in the gut, thereby reducing the production of key inflammatory mediators and increasing anti-inflammatory markers produced by regulatory T cells (Tregs) at sites of inflammation. In 2021, Landos announced preliminary results from a Phase II clinical study evaluating the efficacy of omilancor in patients with ulcerative colitis and expected to initiate Phase III clinical trials in the second half of 2021. Additionally, Landos launched a Phase II clinical study in the first half of 2021 to assess the efficacy of omilancor in treating Crohn’s disease.

NX-13 is a first-in-class, gut-restricted small molecule candidate discovered through Landos’ LANCE artificial intelligence platform for the treatment of ulcerative colitis (UC) and Crohn’s disease (CD). NX-13 targets the mitochondrial-associated receptor NLRX1 and possesses the ability to modulate immune responses. By activating the NLRX1 pathway, NX-13 promotes autophagy and oxidative phosphorylation in immune cells, while reducing the differentiation of CD4+ effector T cells, reactive oxygen species, inflammasome formation, and the production of pro-inflammatory cytokines. Landos announced positive results from its Phase 1a clinical study of NX-13 in healthy volunteers in the first quarter of 2021 and initiated a Phase 1b clinical study of NX-13 in patients with ulcerative colitis in the second quarter of the same year.