The ZY team has developed two Smart Formulation platforms, Active Targeting and Solubility Optimization. Active Targeting allows inclusion of tumor specific targeting ligands to increase the therapeutic index. Solubility Optimization has proven effective in dramatically increasing water solubility, shortening the clinical pathway to market. ZY’s lead formulation was recognized by the Nanotechnology Characterization Lab (NCL), part of a national lab established by FDA, NCI and NIST, in a concerted effort to regulate and support nanotechnology in the oncology space. ZY’s delivery platform benefits pipeline active molecules as well as clinic used drugs, and the technology can be applied to molecules with large span of size, shape and physical-chemical properties. ZY’s formulation tool can be used in different administration routes.
ZY’s first biodegradable nano-formulation of a cytotoxic agent, ZY-010-PNP for solid tumors, completed Pre-IND with the FDA with the 505b(2) regulatory path way and our development proposal agreed to by the agency.

ZY-010-PNP demonstrated a ‘unique drug-release profile’ in in vitro human plasma stable isotope studies conducted by NCL scientists. Another ZY formulation ZY-012-CNP, an active targeting delivery nanomedicine for prostate cancer, is in preclinical development.ZY has a full cancer pipeline of nano-formulations with target indications covering the majority of solid tumors including, but not limited to, TNBC, OC and mCPRC.

ZY’s platform can not only address delivery challenges associated with traditional small chemical molecules, but also work with large biological molecules. ZY’s proprietary biodegradable platform can encapsulate therapeutic peptide to achieve longer circulation time and 1000 increase in solubility. ZY’s formulation technology results in NBCDs (non-Biological complex drugs) which enjoy many advantages in drug development landscape, including improved therapeutic index, easy prescriber conversion and high competition barrier. The common challenges with NBCD development are mostly with difficult manufacturing process, and this is where ZY differentiates from competitors. Majority of ZY’s formulation platform processes are scalable and reproducible. Only class 3 solvents were ever used in the entire process and dosage stability is designed to be prolonged time at ambient temperature to ensure smooth transportation and storage.

Located in Research Triangle Park North Carolina, ZY Therapeutics was established in 2015 and has a strong interdisciplinary R&D team. ZY research and development operates in 4,500+ ft2 lab space equipped with modern chemistry and formulation equipment in the heart of the southeast bio-hub. The core team has a combined decades of pharmaceutical product development experience, with veteran cross-functional leadership.

ZY welcomes inquiries for potential partnerships or collaboration.