Tavanta has a balanced approach to discovery and product development by (i) enhancing the clinical performance of established molecules and (ii) synthesizing novel small molecules and therapeutic peptides.
High Throughput (HT) Matrix Screening Platform
The proprietary HT Matrix Screening platform is a bottom-up approach to improve the pharmacokinetic properties of poorly soluble pharmaceuticals leading to the enhancement of product characteristics such as improved absorption, increased bioavailability which often translates to a faster time of onset and/or dose sparing. The platform can be utilized with established drug molecules or new chemical entities and is designed to expedite the screening of formulation matrices to identify compositions with predicted enhanced solubility, improved absorption and increased bioavailability.
Peptide Conjugate Development Platform
The Peptide Conjugate Development Platform is an integrated approach to the identification, screening, synthesis, and characterization of novel therapeutic peptides. These peptides offer novel treatment modalities for patients with unmet medical needs while circumventing some of the inherent limitations of small organic molecule chemistry.
Once candidate therapeutics are identified, the company uses established pathways to support focused clinical development and regulatory approval. In the United States, these include both the standard 505(b)(1) new drug application (containing reports of safety and effectiveness of the molecule from studies performed by the company), and the expedited 505(b)(2) new drug application (containing reports of investigations of safety and effectiveness from both company-sponsored and referenced data from marketed product literature).
Molecules qualifying for the 505(b)(2) pathway are typically reformulations of FDA-approved drugs, often developed using the proprietary HT Matrix Screening Platform at Tavanta, and may result in opportunities to bring the drug to the market faster compared to the 505(b)(1) pathway.