Xbiome Acquires Clinical-Stage M201 Program for Ulcerative Colitis from Assembly Biosciences

Xbiome Acquires Clinical-Stage Drug Pipeline M201 from Assembly Biosciences, Inc.Recently, Xbiome, an industry-leading AI-driven microbiome drug development company specializing in innovative therapies, announced the acquisition of the clinical-stage drug pipeline project M201 from Assembly Biosciences, Inc. ("Assembly"). Assembly is a clinical-stage innovative therapeutics company primarily focused on hepatitis B virus and other viral diseases. With the support of cutting-edge artificial intelligence and biotechnology platforms, M201 has become Xbiome's third microbiome drug pipeline to enter clinical trials. Xbiome plans to initiate Phase 1b clinical trials for M201 within this year.

M201 Project Targets Patients with Mild to Moderate Ulcerative Colitis. M201 is a rationally designed formula-based microbial drug, developed through an in-depth understanding of the biological and cellular regulatory mechanisms associated with ulcerative colitis. It has been screened and optimized using carefully designed in vitro human cell models and animal models of the disease. The specific terms of the deal were not disclosed by either party.

Xbiome Introduces that It Will Leverage Its AI and Big Data-Driven Drug Discovery Platform to Further Develop M201. Xbiome Is Expected to Initiate the Phase 1b Clinical Trial of M201 in the U.S. Within This Year. This Project Will Become a Key Component of Xbiome's Global Innovation Hub, Starting from the U.S., Where Xbiome Will Work Closely with Its Global Technical Teams in Europe and Asia to Enhance and Support the Continuous Advancement of the M201 Pipeline. According to Reports, This Acquisition by Xbiome Represents One of the Most Significant Acquisition Projects in the Microbiome Pharmaceutical Industry in China and Globally in Recent Times. As a Leader in the AI + Microbiome Pharmaceutical Field, Xbiome Has Fulfilled Its Commitment to a Dual-Driven Strategy for Both Platform and Pipeline Development, Continuously Expanding Its Portfolio of High-Quality Drug Assets Worldwide Through This Transaction.

"Xbiome has always been committed to developing more advanced treatments for ulcerative colitis," said Yan Tan, Co-founder and CEO of Xbiome. "The completion of this transaction demonstrates Xbiome's mission to strategically expand its drug pipeline to achieve medical breakthroughs and meet clinical needs. Moreover, this deal highlights Xbiome's global influence as an AI-driven leader in microbiome therapy and marks a key step in the expansion of our global innovation hub. We look forward to advancing the clinical trial of M201 in the United States in the near future."

It is reported that Xbiome has built a rare and top "AI+BT" platform in the industry, combining artificial intelligence, bioinformatics analysis, and gut microbiome technology to achieve efficient drug development through a "dry-wet integration" approach. Its AI platform, X-Optim, is powered by a cloud-based fully automated computing engine and uses proprietary machine learning algorithms to accelerate microbiome drug discovery. X-Optim enables clinically data-driven drug discovery through its analytics module and target mechanism-driven drug discovery module. Meanwhile, Xbiome's BT platform can further evaluate early-stage drug candidates for rapid validation and targeted optimization.

Through this acquisition, Xbiome has gained its third clinical-stage microbiome drug pipeline. In June 2021, Xbiome officially became the first AI + microbiome pharmaceutical company to enter the clinical stage, with its XBI-302 being the first FMT drug pipeline in Asia to receive FDA clinical approval for the treatment of graft-versus-host disease. In February this year, Xbiome announced an exclusive collaboration and licensing agreement for Greater China with Aurealis Therapeutics to develop and commercialize AUP-16, a clinical-stage drug for treating diabetic foot ulcers, other chronic wounds, and inflammatory diseases. To support platform construction and pipeline advancement, Xbiome completed a Series B round of financing totaling nearly 100 million US dollars in December 2021. Participants included well-known domestic and international investment institutions such as Legend Capital, Gaorong Capital, Cloud9 Capital, 5Y Capital, Primavera Capital, Mountain Travel Capital, and TianTu Capital.

Since its establishment in 2017, Xbiome has expanded its operations to 7 cities globally. Recently, Xbiome set up its U.S. headquarters in Cambridge, Massachusetts, which serves both corporate operations and laboratory functions. Currently, Xbiome’s global workforce has increased to over 200 employees.

About Xbiome

Xbiome Co. Ltd., founded in 2017 and headquartered in Shenzhen, is an industry-leading AI-driven pharmaceutical company specializing in gut microbiome therapeutics, with several programs already in clinical stages. The company boasts an advanced and comprehensive AI-powered microbiome drug discovery platform. Xbiome aims to alleviate or treat diseases using live biotherapeutics and microbial small-molecule modulators, leveraging microbial technology and bioinformatics to address unmet clinical needs. Currently, Xbiome has three drug pipelines in clinical stages targeting ulcerative colitis, diabetic foot ulcers, and graft-versus-host disease; additionally, preclinical-stage drug pipelines are under development for autism and immuno-oncology. Xbiome has collaborated with multiple renowned tertiary hospitals in China on gut microbiome clinical research across various indications, with several microbiome-based drugs demonstrating significant therapeutic effects in clinical studies. At present, Xbiome employs over 200 staff members and operates in Cambridge and New York in the United States, as well as Beijing, Shenzhen, Chengdu, Suzhou, and Dongguan in China.