Federation Bio’s pipeline focuses on serious illnesses with high unmet need and a distinct mechanism of action that can be directly modulated via the chemistry of microbes.

Federation Bio Pipeline


Our lead investigational compound, FB-001, is an oral therapy consisting of 148 microbial strains isolated from multiple healthy donors. The lead indication for FB-001 is enteric hyperoxaluria (EH), a metabolic disorder that affects approximately 250,000 people in the United States. Patients with EH suffer from increased absorption of oxalate in the gut which can lead to recurrent kidney stones, chronic kidney disease, and end-stage renal disease (ESRD). Preclinical data show that FB-001, which comprises both active and supportive microbial strains to create a metabolically complete consortia, potently reduces urinary oxalate, durably engrafts, and is well tolerated. Federation Bio is currently evaluating FB-001 in a Phase 1 clinical trial (NCT05650112) in EH. FB-001 is the first rationally designed complex consortium at this scale to enter clinical studies.


Inflammatory Bowel Disease (IBD) is a chronic disorder characterized by inflammation and hyperpermeability of the gut, with no known pharmacologic cures. FB-003 is a large, diverse consortia targeting markers of microbial dysbiosis associated with IBD. Our preclinical data shows stable engraftment of FB-003 throughout the gut, reduced dysbiosis, high levels of SCFA production and normalization after challenge, improved bile acid deconjugation, and ultimately improvement in clinical outcomes in a DSS colitis mouse model. 

Immunotherapy-Refractory Cancers

Immune checkpoint inhibitors (CPIs) and other forms of immunotherapy have dramatically improved outcomes for many with cancer, but a high percentage of patients do not benefit from these treatments.1 Previous work demonstrates that the gut microbiome is a key mediator of individual response to CPIs.2 Fecal microbiota transplants (FMT) from individuals who respond to CPIs have demonstrated potential to improve outcomes for patients who did not benefit, but the inability to scale up manufacturing or modify FMT for enhanced therapeutic benefit has hindered the application of FMT in this setting.3,4

Federation Bio is collaborating with researchers at The University of Texas MD Anderson Cancer Center to rationally design a complex consortium of bacteria derived from a donor fecal sample that has demonstrated ability to improve immunotherapy responses in cancer patients via FMT. Federation Bio will use its ACTTM platform to manufacture the consortium from purified cell lines, generating a therapy that comprises the full metabolic complexity of the identified microbiome and is optimized for therapeutic benefit.

  1. Sharma P, Hu-Lieskovan S, Wargo JA, Ribas A. Primary, Adaptive, and Acquired Resistance to Cancer Immunotherapy. Cell. 2017 Feb 9;168(4):707-723.
  2. Khan MAW, Ologun G, Arora R, McQuade JL, Wargo JA. Gut Microbiome Modulates Response to Cancer Immunotherapy. Dig Dis Sci. 2020 Mar;65(3):885-896. 
  3. Baruch EN, et al. Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. Science. 2021 Feb 5;371(6529):602-609. 
  4. Davar D, et al. Fecal microbiota transplant overcomes resistance to anti-PD-1 therapy in melanoma patients. Science. 2021 Feb 5;371(6529):595-602.