Xbiome Acquires Clinical-Stage Program Targeting Ulcerative Colitis

Xbiome expects to commence Phase 1b trial of next-generation oral live biotherapeutic product program M201 in 2022

Adds a third clinical-stage program to Xbiome’s growing pipeline supported by cutting-edge artificial intelligence and biotechnology platforms

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Xbiome Inc., an industry leading AI driven microbiome therapeutics company, today announced that it has acquired the clinical-stage M201 program from Assembly Biosciences, Inc., a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus and other viral diseases.

The M201 program is designed for patients with mild to moderate ulcerative colitis. M201 is comprised of a rationally designed consortium of commensal bacteria that were selected based on their ability to modulate ulcerative colitis-relevant cellular mechanisms in human cell-based assays and animal models. Terms of the transaction were not disclosed.

Xbiome will develop M201 leveraging its AI and data platform. This acquisition reflects Xbiome’s commitment as one of the leaders in the rising field of microbiome therapeutics. Xbiome is expected to commence the M201 Phase 1b clinical trial in 2022 in the US and the program will become part of Xbiome’s Global Innovation Center, where Xbiome will work closely with its global technology team in Europe and Asia in order to enhance and support the continued development of M201.

“This acquisition demonstrates our commitment to developing an enhanced treatment for ulcerative colitis, as well as our broader commitment to strategically growing our pipeline to pioneer medical breakthroughs,” said Yan Tan, Founder and Chief Executive Officer of Xbiome. “This announcement marks a pivotal step in Xbiome’s continued global impact as an industry leader in AI-driven microbiome therapeutics and expansion of our recently established Global Innovation Center. We look forward to progressing the M201 clinical trial in the US in the very near future.”

Xbiome combines a cutting-edge AI approach and microbiology platform to decode the human gut microbiome for novel drug discovery. Its AI platform, X-Optim, accelerates microbiome drug discovery with proprietary machine learning algorithms. X-Optim is powered by a cloud-based, fully automated computational engine. X-Optim enables clinical data-driven drug discovery with its analytical module, as well as its targeted mechanism-driven drug discovery module. Early drug candidates are further evaluated by its microbiology platform for rapid validation and targeted optimization.

This acquisition adds a third clinical-stage program to Xbiome’s rapidly growing pipeline. Xbiome entered the clinical phase in June 2021, with its XBI-302, Asia’s first FDA-approved Fecal Microbiota Transplantation human trial on graft-versus-host disease. Most recently in February 2022, Xbiome announced an exclusive license and collaboration agreement with Aurealis Therapeutics for the clinical development and commercialization of a clinical-stage program targeting the treatment of Diabetic Foot Ulcer (DFU), other chronic wounds, and inflammatory diseases. To support these programs, Xbiome completed a $100 million Series B financing in December 2021 that included the participation of Legend Capital, Gaorong Capital, 5Y Capital, Primavera Capital Group, Wuyuan Capital, Chunhua HIKE Capital and Tiantu Capital. The company had previously raised $7.5 million in Series A financing in 2018.

Since its founding in 2017, Xbiome has expanded its operations across seven cities, established its culturomics and AI platforms and grown its global employee base to over 200. The company most recently established its US headquarters in Cambridge, Massachusetts which includes both corporate and laboratory presence.

About Xbiome

Xbiome is an industry-leading clinical stage AI-based microbiome drug development company dedicated to tackling unmet medical needs through various modalities of microbiome therapeutics including fecal microbiota transplantation (FMT), live biotherapeutic product (LBP), and small molecule microbiome modulator (SMMM). Xbiome currently has three clinical-stage programs in its pipeline focused on Ulcerative Colitis, Diabetic Foot Ulcer and Graft vs. Host Disease. In addition, Xbiome has earlier-stage programs in autism spectrum and immuno-oncology. Xbiome was founded in 2017 and has established its culturomics and AI platforms since its inception. Xbiome has over 200 employees and has operations in Cambridge, MA, New York, Beijing and Shenzhen. For more information, go to www.xbiome.com

Contacts

Hermione He

Chief Operating Officer

[email protected]