FMT_XBI302

Xbiome Inc, an AI-focused microbiome therapeutics developer has acquired a new clinical asset – M201 for ulcerative colitis (UC) – from Assembly Biosciences, a biotech specializing in viral diseases such as hepatitis B. The M201 program is designed for patients with mild to moderate UC. The therapeutic consists of a mix of commensal bacteria selected for their ability to modulate UC-related cellular mechanisms in human cell-based assays and animals. Taking the reins of M201 from Assembly, Xbiome will use its AI-based microbiology platform to develop M201. The platform, called X-Optim, claims to accelerate microbiome drug discovery with machine learning. Xbiome’s drug discovery approach involves screening early drug candidates based on their mechanism of action, then validating and optimizing candidates on its microbiology platform. According to Xbiome Founder and CEO Yan Tan, M201 is expected to head into Phase1b in 2022 in the US, and will receive development support from Xbiome’s tech team in Europe and Asia. The M201 acquisition marks Xbiome’s third clinical-stage addition to its pipeline. The company first stepped into human trials with XBI-302, Asia’s first FDA-approved Fecal Microbiota Transplantation (FMT) human trial on graft-versus-host disease. Xbiome’s second clinical-phase program targets diabetic foot ulcers, chronic wounds and inflammatory diseases. The program was licensed from Aurealis Therapeutics for development and commercialization. Earlier-stage programs in Xbiome’s pipeline target the autism spectrum and immuno-oncology. Besides FMT, Xbiome’s other modalities include live biotherapeutic product (LBP) and small molecule microbiome modulators (SMMM). To support these programs, Xbiome last December completed a $100 million Series B financing round joined by a cluster of Chinese investors, including Legend Capital, Gaborone Capital, 5Y Capital, Primavera Capital Group, Wuyuan Capital, Chunhua HIKE Capital and Tiantu Capital. The company previously raised $7.5 million in Series A in 2018. For a startup founded in 2017, Xbiome has since expanded across seven cities and grown its staff to over 200. The company recently set up US headquarters in Cambridge, Massachusetts for its business leadership and R&D.