Shenzhen Xbiome Biotech Co. Ltd., an artificial intelligence (AI)-based microbiome drugmaker, raised more than $20 million in a series B+ round, Xbiome CEO Yan Tan told BioWorld, financing that will help the company launch its phase I trial next year. It has been a year since the drugmaker closed a $14 million series B round. During this period, Tan said Xbiome submitted an IND to the FDA in October for its fecal microbiota transplant (FMT) capsule candidate, a potential treatment for graft-vs.-host disease.

“It's a tough year for us and the whole world. We managed to keep our investigator-initiated trials running in the second half of 2020 and successfully submitted an IND package,” he said. “On the AI and bioinformatics side, we have built a couple of new pipelines to profile strains in a more precise level and have increased our strain library and already screened over 1,000 strains on our platform.”

“We will put more resources on the consortia design platform next year and will also start building a BGC platform to utilize metabolites from gut bacteria for drug development,” he added.

The new financing was co-led by Primavera Capital and Gaorong Capital, and supported by 5Y Capital, Legend Capital, Yimei Capital and Yayi Investment, most of which were existing investors. Xbiome called it the biggest financing round for a microbiome-focused drugmaker in China. Previously, the company completed four financing rounds to raise around $38 million.

“As clinical trials are being carried out smoothly by a few U.S. microbiome-focused pharmaceutical companies, this area of research is getting more attention globally and support from traditional pharma companies, regulators and investors,” Tan said. “Now that microbiome-based drug development is becoming more mature, I hope Xbiome will represent China in this space.”

Once Xbiome receives an IND approval from the FDA, it will be the first Asian drugmaker to have an FMT therapy candidate cleared for trials in the U.S., the company said.

Leveraging technology, partnerships

The microbiome drugmaker has sought to distinguish itself by combining AI and big data with gut microbiome modulation to develop novel drugs. In doing so, it has built a multi-omics computing platform, a key bacteria discovery platform and a microbiome knowledgebase while also establishing a culturomics platform, an animal model verification platform and a production platform for microbiome therapeutics.

Other tools in its kit a high-throughput bacterium functional screening system, germ-free animal models and gut microbiota humanized mouse models. Meanwhile, its AI team is working to extract useful knowledge about the microbiome and its interplay with the human body from literature and publicly available large-scale datasets.

As its work on immuno-oncology, neurological disorders and autoimmune diseases gains momentum, it has helped launch investigator-initiated trials with hospitals in Beijing, Shanghai and Guangzhou and also collaborated with Jiangsu Hengrui Medicine Co. Ltd. in immuno-oncology and with Eisai Co. Ltd. in Alzheimer’s disease. With gut microbiota as biomarker, Xbiome also built a prediction model for cancer patients who received anti-PD-1 immunotherapy.

“Our current pipeline focuses on autism and combinatory treatment with PD-1 immunotherapy in a variety of tumors,” Tan told BioWorld previously. “The microbiome has been linked to many other diseases in the last few years, and we will continue looking into new indications as evidence comes up.”

Sharing the Xbiome team’s long-term plans at a biotech conference in Shenzhen on Nov. 20, the company’s chief scientist, Hu Han, said that since the start, “we planned to build a comprehensive R&D platform in one to three years,” which gradually expanding the company's focus on disease prevention.

Pointing to just how hot FMT research has become, Hu said there are 331 FMT-related studies globally. Though microbiome-based drug development is still in its infancy in China, Xbiome's team hopes to become a frontrunner in the field. As it pursues that goal, it will compete with other international forerunners, such as Finch Therapeutics Inc., Vedanta Biosciences Inc., Seres Therapeutics and Evelo Biosciences Inc. Seres reported top-line data from the pivotal phase III study of SER-109 in August, while Finch raised $90 million in a series D round in September.