Xbiome acquires live biotherapeutic product program targeting ulcerative colitis

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Xbiome Inc, a China headquartered AI-based microbiome therapeutics startup, has acquired the clinical-stage M201 program developed by Assembly Biosciences, a firm developing therapeutics targeting hepatitis B virus and other viral diseases.

The deal adds a third clinical-stage program to Xbiome’s rapidly growing pipeline.

Terms of the transaction were not disclosed. 

The oral live biotherapeutic product (LBP) program, M201, is designed for patients with mild to moderate ulcerative colitis. It 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.

Microbiome therapeutics pipeline 

Xbiome is focused on tackling unmet medical needs through various modalities of microbiome therapeutics including fecal microbiota transplantation (FMT), LBPs, and small molecule microbiome modulator (SMMM).

The company 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. In February 2022, it 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 projects, Xbiome completed a US$100m 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 US$7.5m in a Series A financing round in 2018.

Xbiome said it will develop M201, leveraging its AI and data capabilities. The company outlined how its AI platform, X-Optim, accelerates microbiome drug discovery via machine learning algorithms. The platform is powered by a cloud-based, fully automated computational engine.

Clinical development 

The startup expects to begin the M201 Phase 1b clinical trial in 2022 in the US.

Xbiome recently established its US headquarters in Cambridge, Massachusetts, which includes both corporate and laboratory presence. It also has operations in New York, Beijing, and Shenzhen.