We have pioneered ORAL no-needle biologics with our first-in-class live yeast modality called Bioengineered Probiotic Yeast Medicines (“BioPYM”) for targeted and restricted GI biologics delivery.  BioPYM was built on non-dilutive NIH $24 MM  and Phase 1 clinical trial is targeted for 2025. The Fzata Tetrabody Platform is used to create multi-targeted, highly potent IgGs based on human VH or humanized VHH domain antibodies.

 

BioPYM Platform Overview: 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 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 BioPYM, 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 BioPYM candidate 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