Fzata has developed a next-generation oral biologics modality: bioengineered probiotic yeast medicines built on its proprietary BioPYM™ platform.   The BioPYM™ yeast platform generates ORAL no-needle biologics for targeted and restricted GI biologics delivery.  The BioPYM platform was built on non-dilutive NIH $24 MM  and Phase 1 clinical trial is targeted for summer 2026. The Fzata Tetrabody Platform is used to create multi-targeted, highly potent IgGs based on humanized VHH domain antibodies.

 

BioPYM Platform Overview: The BioPYM™ oral biologic 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 re-hydrated in the GI, yeast act like micro-factories and make biologic 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 PK is 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 drugs made from the BioPYM yeast technology, further enhancing a very high safety profile.

  

BioPYM yeast platform is engineered with a “plug-n-play” genomic insertion site for the DNA payload. Each drug candidate made using the BioPYM platform will enjoy significant redundancy for cost and time savings with respect to CMC, formulation, packaging and stability studies.  Our manufacturing will be considerably less expensive and much faster than conventional biologics which must be highly purified for IV or SC injection.  Learnings from our lead BioPYM product will de-risk and lower costs and time for subsequent platform drug candidates.    Please see preclinical publication in Science Translational Medicine.

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US Issued  Patents: 10,961,299; 11,466,075; 12,077,575