5Y News｜Unknown Closes Tens of Millions of Dollars in Series B+ Funding to Advance Microbiome Drug Clinical Trials
Leading domestic microbiome therapeutics company Unknown has recently completed a tens-of-millions-of-dollars Series B+ funding round, with continued backing from 5Y Capital.
Unknown, a leading domestic microbiome therapeutics company based in Shenzhen, recently completed a tens-of-millions-of-dollars Series B+ funding round. The round was led by Primavera Venture Partners and Gaorong Capital, with follow-on investments from 5Y Capital (formerly Morningside Venture Capital), Legend Capital, Yimei Capital, and Yayi Capital. The proceeds will primarily fund clinical trials scheduled for 2021, new drug pipeline R&D, and continued development and expansion of Unknown's six existing platforms. China Renaissance served as the exclusive financial advisor for this round.
Xutian Jing, Executive Director at 5Y Capital, commented: "Three years ago, 5Y Capital chose to believe that new drug development through the gut microbiome was possible, based primarily on our logical deduction combining research from published literature with our understanding of machine learning and bioinformatics developments. Three years later, we're pleased to see North American companies that have worked in this space for years achieve relatively clear technical validation, greatly increasing the certainty of success for this industry. While Chinese companies started later in this field, China has greater data resources and clinical resources that can significantly improve R&D efficiency, and Unknown's team possesses world-leading technical capabilities. Over the past three years, Unknown has built a complete microbiome drug development platform and industry resource network, and already has drug candidates at the FDA IND application stage. We believe that in this new therapeutic category, China's new generation of biopharmaceutical companies can achieve world-leading drug development progress across many disease areas."
Founded in 2017, Unknown leverages an innovative drug development model and proprietary development platforms, combining artificial intelligence with gut microbiome technology to achieve high-quality data analysis, accumulation, and output — bridging the conversion chain from "data" to "drugs" and creating a complete closed loop for microbiome drug R&D that dramatically improves development efficiency and success rates. Unknown develops gut microbiome drugs targeted to the specific microbiome profiles of patients with different indications, for the treatment of multiple conditions, effectively advancing microbiome therapeutics from laboratory-stage scientific exploration to industrial-scale implementation.
According to available information, Unknown submitted an IND application to the U.S. FDA in October 2020 for aGvHD (acute graft-versus-host disease), and in Q4 2020 will continue to submit an IND application to the FDA for its ASD (autism spectrum disorder) program. Upon approval, Unknown will hold Asia's first FDA-cleared FMT drug and China's first FDA-cleared microbiome drug. Additionally, Unknown plans to add 3-5 new drug pipelines in 2021.
Dr. Yan Tan, founder of Unknown, stated: "As several U.S. microbiome pharmaceutical companies advance smoothly through clinical trials, the microbiome therapeutics track is receiving increasing international attention and gaining recognition and support from traditional pharmaceutical companies, regulatory agencies, and investors. We thank our investors for their continued recognition and support of both the microbiome therapeutics industry and Unknown. The industry is gradually maturing, and we hope Unknown can represent China in joining the top tier of this field internationally."
01
Microbiome Drugs Have Become a Global Consensus in New Drug Development
With the advancement of the Human Microbiome Project, understanding of gut microorganisms and their relationship to human health and disease has deepened considerably. Progress by companies such as Seres and Finch Therapeutics demonstrates that the microbiome therapeutics industry has entered a mature translational stage.
Currently, microbiome drugs primarily take four forms: fecal microbiota transplantation (FMT), defined consortia, bacterial metabolites, and engineered bacteria. Overall, the microbiome therapeutics industry is becoming increasingly systematized, with the mainstream development approach proceeding from clinical or human data to identify drug-worthy bacteria or bacterial products, followed by strain isolation and in vitro and animal testing.
Dr. Tan notes that the rapid development of cultivation technologies — particularly high-throughput automated cultivation, high-throughput multi-dimensional in vitro screening assays, and germ-free animals (especially disease-model germ-free animals) — combined with widespread application of frontier technologies including multi-omics analysis, ecology and AI modeling, and strain analysis algorithms, has put global microbiome drug R&D on the fast track.
Among these, FMT therapeutics have advanced most quickly clinically, with drugs already completing Phase III trials. The first FMT drug is expected to receive FDA approval by late this year or next year. Meanwhile, defined consortia drugs internationally are gradually entering Phase II, and bacterial metabolite drugs are entering Phase I.
02
Building a Precise and Comprehensive Microbiome Drug Knowledge Base
Within the microbiome therapeutics industry, Unknown possesses internationally leading data mining and analysis capabilities that substantially reduce data noise, improve data interpretability, and deeply parse key pathways and major contributing bacteria in disease onset and improvement processes — constructing a complete information chain for microbiome drugs from "bacteria → genes → pathways → products → functions." Data-side analytical mining work integrates with downstream experimental strain development to achieve a complete closed loop for microbiome drug discovery.
Unknown's AI drug discovery platform
In terms of data volume, Unknown maintains the world's largest gut microbiome sample bank and sequencing dataset from patients before and after PD-1 immunotherapy. The company also integrates public datasets with massive proprietary microbiome data from healthy individuals and patients across multiple indications before and after treatment, building and continuously expanding Unknown's proprietary knowledge base — the most comprehensive gut microbiome knowledge base currently in existence globally. All data in the knowledge base and their corresponding samples undergo standardized reprocessing and effective integration. The team now possesses over 5,000 individual data points across healthy and diseased populations, over 8,000 host gene-gut microbiome association data points, and over 340,000 microbe-disease association data points. Based on this continuously expanding database, Unknown's predictive model using gut microbiome as a biomarker for tumor patients receiving PD-1 immunotherapy has achieved internationally advanced prediction accuracy.
For data mining, Unknown independently developed "Xstrain," the first tool to directly parse strain composition and corresponding genes from metagenomic sequencing data. This improves strain detection sensitivity while enabling functional-level strain analysis and screening, substantially reducing dependence on strain isolation experiments and accelerating strain screening. Another data tool, MSEA, applies natural language processing to predict host functional changes from microbial communities, pioneering the direct prediction of host gene-level regulation from changes in microbiome composition — enhancing understanding of microbe-host interactions and interpretation of microbial physiological effects.
For knowledge extraction, Unknown has integrated the most comprehensive known human gut microbiome reference genome database, developed proprietary deep genomic annotation for specific microbial metabolites, and adopted a "data-driven + hypothesis-driven" approach. Combining microbial correlation relationships extracted from multi-omics data with prior knowledge integrated from the knowledge base, the company leverages machine learning and deep learning tools to extract key bacteria related to specific indications and deduce mechanisms of action, guiding downstream strain development.
For clinical translation, Unknown maintains an innovative R&D platform capable of sustainably generating breakthrough microbiome drugs, targeted intestinal-release microbiome protection and microcapsule technology, high-purity high-activity full-spectrum gut microbiome drugs, rigorous standardized donor screening protocols, a developed high-end animal model validation platform, and FDA-recognized processes at multiple production stages.
03
Focused on Advancing Clinical Application of Microbiome Drugs
Currently, Unknown has established gut microbiome clinical research collaborations with multiple renowned domestic medical institutions, with several microbiome drug candidates demonstrating significant therapeutic effects in clinical studies. For example, Unknown's collaboration with Peking University Cancer Hospital on "Clinical Study of Gut Microbiota Transplantation Capsules to Improve PD-1/PD-L1 Efficacy in Cancer Patients" represents the world's first and largest combined study in the gastrointestinal oncology field on microbiome drug co-administration with tumor immunotherapy. Meanwhile, Unknown is collaborating with Nanfang Hospital, Southern Medical University on a gut microbiota capsule treatment for aGvHD, and submitted an IND application to the U.S. FDA in October 2020 for GvHD (graft-versus-host disease).
"Unknown's main drug pipelines are all self-developed," Dr. Tan noted. "The team's proprietary pipelines include combination therapy with anti-PD-1 tumor immunotherapy, autism, aGvHD, and other indications." In 2021, Unknown will enter a product-driven phase, becoming a microbiome drug company powered by both technology and products — actively advancing clinical trials while continuously strengthening its technology platform, accelerating pipeline R&D going forward, building broader and more valuable drug pipelines, and providing patients with more and better microbiome drugs.
Unknown's pipeline in development
Dr. Tan plans to progressively open Unknown's various technology platforms, strengthening clinical research and new technology collaborations with more medical institutions on one hand, and deepening microbiome R&D collaborations with major pharmaceutical and probiotic companies on the other. Leveraging its germ-free animal platform, AI platform, cultivation platform, and others, Unknown aims to empower the entire microbiome therapeutics industry. "Going forward, Unknown will build on its deep accumulated expertise in microbiome therapeutics to expand to broader healthy populations, providing prevention and wellness for microbiome-related diseases, and becoming a leader in human health based on the microbiome."
Recently, Unknown was selected for MIT Technology Review's 2020 "50 Smartest Companies" list for its precise predictive model using gut microbiome as a biomarker for tumor patients receiving PD-1 therapy, with the company's continued innovative exploration in microbiome therapeutics receiving increasing recognition.
5Y Capital (formerly Morningside Venture Capital) currently manages approximately US$3 billion across USD and RMB dual-currency funds. We believe that if the "crazy" you that others see begins to be believed in, the world becomes a better place.
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