In the last decade, a relatively uncharted field exploded in the life science industry, provoking Forbes to declare the 2010s “The Decade of the Microbiome.” This expansion in the microbiome field was largely due to The National Institutes of Health’s “The Human Microbiome Project,” ending in 2016, which provided significant evidence for the association between metabolic disorders, neurological disorders, autoimmune diseases, allergies, infections, and cancers and the microorganisms that live on and in humans. Specifically, gastrointestinal autoimmune diseases, including inflammatory bowel diseases, Crohn’s disease, celiac disease, and more, are accumulating attention with their close relation to the gut microbiome. Because of these findings and the critical role the gut microbiome plays in drug metabolism, the microbiome has become a popular target in the biotechnology industry.
CipherBio PRO’s Microbiome Insights page explores the microbiome-focused biotechnology companies that received investments from 2019-2021. 64 companies with 133 investors, 146 indications, and over 230 scientific approaches received a total of $1.6 Billion in invested capital. Additionally, these companies are separated into their respective clinical phases.
Furthest along in clinical development is Finch Therapeutics, which has completed a phase 2 trial with plans to initiate phase 3 later this year. Cambridge MA-based Finch Therapeutics went public in March of this year with a $128M IPO only 6 months after raising a $90M Series D from Baupost Group, Humboldt Fund, MSD Capital, Octave Group, and OMX Ventures, Avenir Growth Capital, OCV Partners, Shumway Capital, SIG, SymBiosis, TPTF, and Willett Advisors. Finch’s lead product candidate, CP101, received Fast Track and Breakthrough Therapy designations by the FDA for the prevention of recurrent C. difficile infection (CDI). While CDI is usually caused by antibiotic use, the only approved treatment is another antibiotic that has been shown to disrupt the microbiome, and often lead to CDI recurrence. Finch’s antibiotic-free therapeutic candidate is designed to restore the microbiome, joining the fight against antibiotic resistance.
While the majority of the companies target the gut, 11 of the companies target the microbiota of a different region, the human skin. The skin microbiome company that raised the biggest round is BiomX, which went public in October 2019 just a few months after raising a $32M Series B led by OrbiMed, JJDC, Inc., Takeda Ventures, 8VC, MiraeAsset, Seventure Partners, SBI Japan-Israel Innovation Fund, and RM Global Partners. BiomX uses bacteriophage therapeutics to target pathogenic bacteria. Their lead product candidate is in phase 2 trials for Acne and a second product is in preclinical studies for atopic dermatitis.
One of BiomX’s investors, Seventure Partners, is making a number of bets on companies tackling specific indications using the microbiome. Seventure Partners, a France based leading European venture capital firm founded in 1997, has funded over 250 digital health and life science companies and has over $870 Million assets under management. Seventure made investments in 6 microbiome companies and is the 2nd top investor after SOSV who funded 8 companies as a part of their IndieBio accelerator. Five of Seventure’s companies are in clinical trials with three already in phase 2. Seventure participated in four series B’s within a year and a half. Additionally, three of the companies are working on cancer indications, three of them are working on metabolic disorders, and three of them are working on autoimmune diseases.
Seventure Partners Investments
|Enterome||June 2020||Series E||$52.6M||IBS, Crohn’s, glioblastoma, adrenal tumors, b-cell malignancies|
|Federation Bio||September 2020||Series A||$50M||secondary hyperoxaluria, cancer|
|Siolta Therapeutics||February 2019||Series B||$30M||atopic dermatitis, allergies, asthma, metabolic disorders|
|BiomX||February 2019||Series B||$32M||acne, atopic dermatitis|
|Axial Biotherapeutics||February 2019||Series B||$25M||Autism, CNS disorders|
|MaaT Pharma||February 2019||Series B||$20M||GvHD, hematological malignancies|
While the gut microbiome and skin microbiome top the approach list along with microbiome restoration, the top mechanism of action to target these regions and restore the microbiome is bacterial therapy. With only one bacterial agent approved by the FDA, Bacillus Calmette-Guerin (BCG) for the treatment of non-muscle invasive bladder cancer (NMIBC), these biotech companies are looking to use this uncommon technique to modulate and restore the microbiome.
The bacterial therapeutics company with the top deal is Palo Alto based Federation Bio, which launched with a $50M series A in October 2020 led by Horizon Ventures and participation from Venrock, Altitude, and Seventure Partners. Federation Bio’s platform uses engineered and naturally produced commensal bacteria with their lead candidate in IND studies for secondary hyperoxaluria, a metabolic disorder with no approved treatments.
Farther along in clinical development are four bacterial therapeutics companies in phase 2 trials. Vedanta Biosciences raised a $62M series C in 2019 and a $25M round from Pfizer Inc. in January 2021 and is currently evaluating their most advanced product in phase 2 trials for CDI Infections. 4D Pharma went public in March 2021 through a $25M SPAC merger, and is currently accessing their lead bacterial therapeutics in phase 2 trials for irritable bowel syndrome and COVID-19. MatriSys Bioscience raised a $3M bridge financing in March 2021 with proceeds going towards their clinical candidate in phase 2 trials for Atopic Dermatitis. The fourth company, Notitia Biotechnologies, raised a seed round in December 2020, and their phase 2 product is in trials for the treatment of covid-19.
Recent research has pointed to the human microbiome as the origin of a wide variety of disorders and catalyzed the exploration of a whole new swathe of treatments. This potential for microbiome therapeutics presents a new exciting and revolutionary approach for the life science industry.