Fzata has developed a next-generation oral biologics platform, Bioengineered Probiotic Yeast Medicines (BioPYM™). BioPYM™ uses live, genetically engineered yeast to deliver a DNA payload that enables the yeast to function as a localized “micro-factory,” producing therapeutic biologics directly within the gastrointestinal tract.
The company has built a robust pipeline of BioPYM™ drug candidates targeting gastrointestinal diseases and disorders mediated by the gut–health axis. There is strong market demand from both patients and payors for alternatives to today’s injectable biologics, which are costly, fragile, require cold-chain storage, and are administered by needle. BioPYM™ medicines are designed to be patient-friendly oral pills that do not require refrigeration.
Since 2015, Fzata has secured $24 million in non-dilutive funding from the National Institutes of Health (NIH), providing external validation of the platform and underlying science. The NIH is sponsoring Fzata’s lead program, FZ002, in a Phase 1 clinical trial scheduled for 2026. Successful clinical results are expected to significantly de-risk the first-in-class BioPYM™ platform and position the company for future investment and strategic partnerships.
The BioPYM™ platform enables therapeutic biologics like antibodies, enzymes, cytokines, and hormones to be targeted to the gut. Patients will take an oral capsule containing live, lyophilized therapeutic yeast. Once rehydrated in the GI, yeast acts like micro-factories and makes biologics in the gut at the disease location. The yeast itself acts symbiotically with flora in the gastrointestinal tract, beneficially modulating gut function and immune homeostasis. Yeast will not colonize, so pharmacokinetics are controllable through dosing. In addition, BioPYM™ yeast can be used concurrently with antibiotics and will not trigger drug resistance. Finally, there is no anti-drug-antibody (ADA) response to BioPYM, further enhancing a high safety profile.
The BioPYM™ yeast platform is engineered with a “plug-n-play” genomic insertion site for the DNA payload. Each BioPYM™ candidate will enjoy significant redundancy for cost and time savings with respect to CMC, formulation, packaging and stability studies. Fzata’s manufacturing will be less expensive and faster than conventional biologics, which must be highly purified for IV or SC injection. Learnings from the company’s lead BioPYM™ product will de-risk and lower costs and time for subsequent platform drug candidates.
"The I-Corps program was highly impactful for Fzata. Information gathered and analyzed when the company was young formed a solid business foundation that was critical for the competitive SBIR grant funding we subsequently won from the NIH."
—Zhiyong Yang, Co-Founder and CEO, Fzata
I-Corps Team: Zhiyong Yang, Co-Founder and CEO, Fzata, Inc.; I-Corps Cohort: JHU regional cohort, spring 2016; Funding: $24M
