BEIJING – Shenzhen-based Xbiome Co. Ltd., said to be China’s first AI-based microbiome drug development company, closed a series B financing round to pocket ¥100 million (US$14 million). The proceeds will help the biotech expand its technology platforms and advance its microbiome-based drug candidates to the clinical stage.

“It is the biggest financing round in China's microbiome drug development so far,” Xbiome CEO Yan Tan told BioWorld. “We think it is a sign that Chinese venture capitalists are seriously looking into microbiome therapeutics to catch up with the global trend in this field.”

A computational biologist by training, Tan founded Xbiome in 2017 to focus on combining artificial intelligence and big data with gut microbiome modulation to develop novel drugs. It stands out from other drugmakers who follow the conventional “cell-animal-human” paradigm of drug development.

In merely two years, Xbiome has completed three financing rounds to raise around $24 million. The previous round closed only five months ago.

For now, Xbiome is focusing on microbiome-based therapies to treat neurological, immune and metabolic diseases. The biotech has built a complete preclinical platform for the new therapeutic regimen.

“Our current pipeline focuses on autism and combinatory treatment with PD-1 immunotherapy in a variety of tumors,” Tan said. “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.”

Xbiome is now working with research hospitals in China to conduct clinical studies and is seeking IND approval from the U.S. FDA to push one or two of its drug candidates into phase I trials next year. Proceeds from the latest round will support Xbiome in finishing one phase I study.

Gut microbiome: A space yet to be tapped

Xbiome is one of the earliest companies in China to identify and believe that microbiome-based therapy will be a new paradigm of drug development.

“Scientists now acknowledge the gut microbiome as the ‘second genome’ of humans. However, modern medicine never treats gut microbiomes as a main drug target for systematic and complicated diseases,” said Tan.

“Now we have the technology at hand to explore new treatments and drugs that may have a profound effect on human health through the gut microbiome. It provides a new way of thinking and treating diseases, particularly immune, metabolic and chronic diseases, which are difficult to treat and manage,” he added.

That said, Tan noted that microbiome-based drug development is still at its infancy.

Xbiome is not alone in believing in the role that the gut microbiome plays in health and disease. Earlier this month, Chinese drugmaker Shanghai Green Valley (Group) Co. Ltd. received a lot of industry attention when its GV-971 was approved to treat Alzheimer's disease in China. The company said GV-971 can remodel the gut microbiome and suppress gut bacterial amino acid-shaped neuroinflammation to inhibit Alzheimer’s disease progression.

Stepping up the tech game

But specializing in the gut microbiome isn’t easy. It requires the help of modern technology such as machine learning to unlock the secrets.

“The gut microbiome is a complicated ecosystem. We have to leverage state-of-the-art machine learning tools to discover bacteria that present a therapeutic effect,” said Tan.

“What is more challenging than traditional machine learning problems is that we are dealing with extremely small sample sizes and much higher feature dimensions. We need to be sophisticated at feature engineering. The machines or algorithms are only as good as the training set. However, so much is yet to be discovered in the microbiome world,” he explained.

The biotech has combined various new technologies to study the human microbiome, such as automated large-scale culturomics, a high-throughput bacterium functional screening system, germ-free animal models as well as gut microbiota humanized mouse models.

Meanwhile, its AI team is also working hard to extract useful knowledge about the microbiome and its interplay with the human body from literature and large-scale datasets that are available publicly.

Now, with $14 million more in its pocket, Xbiome plans to further develop its preclinical R&D platforms, which include a multi-omics and AI platform, a culturomics platform and an in vitro and in vivo platform, as well as its manufacturing platform. The biotech can also continue its current studies and dig deeper into the biological mechanisms of the microbiome's therapeutic effects.

 “We plan to build a rigorous donor screening and management pipeline that ensures the safety and efficacy of our fecal microbiota transplantation product. We will investigate the human data collected throughout our clinical trials,” Tan said.

“Ultimately our goal is to build a platform that centers around the gut microbiome, allowing us to discover beneficial bacteria and their therapeutic indications,” he added.

No Comments