Oral Biologics First-in-Class Modality
A Live BioTherapeutic Product (LBP)
We have pioneered no-needle biologics with our first-in-class live yeast modality called Bioengineered Probiotic Yeast Medicines (“BioPYM”) for targeted delivery of biologics to the GI. BioPYM was built on non-dilutive NIH $17M and Phase 1 clinical trial is targeted for 2024. The Company also owns a Tetrabody Platform 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. The drug is an oral capsule containing live, lyophilized therapeutic yeast. This is a live biotherapeutic product of LBP. The orally administered yeast micro-factories activate and make therapeutic 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, and therapy may be administered chronically while symptoms persist. In addition, BioPYM yeast can be used concurrently with antibiotics and will not trigger drug-resistance. Finally there is no anti-drug-antibody 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 traditional biologics which must be highly purified for IV or SC injection. Learnings from our first BioPYM product will de-risk and lower costs and time for our following BioPYM drug candidates. Please see preclinical publication in Science Translational Medicine.
BioPYM Diagram Description
Our innovative pipeline utilizes a probiotic yeast that are genetically engineered to express and secrete therapeutic proteins. 1) Fzata BioPYM capsules contains live lyophilized probiotic yeast engineered to treat specific diseases. 2) The capsule is designed to release the live probiotic yeast in the small intestine where they act as micro-factories making therapeutic proteins. 3) In the case of inflammatory diseases, yeast produces antibodies to sequester and inactivate inflammatory mediators at the site of inflammation. 4) Colonic inflammation is suppressed by the actions of both therapeutic proteins and probiotics and normal gut microbiota is restored.