US-based Lpath has begun patient dosing in Phase 2a single-arm trial of anti-cancer drug, Asonep.
The first proof-of-concept trial is designed to study effects of the humanized antibody in subjects with renal cell carcinoma (RCC).
RCC patients who failed the standard of care treatment with FDA-approved agents that block VEGF signaling such as Sutent/sunitinib maleate and the mTOR pathway such as Afinitor/everolimus will be included in the study.
Asonep binds to and neutralizes sphingosine-1-phosphate (S1P) that is proven to progress several cancer types and has been validated as a drug target in multiple sclerosis.
The company has successfully completed Phase 1 safety study in which Asonep was well tolerated across all doses in subjects with solid tumors.
A $3m grant from the National Cancer Institute (NCI) under its Small Business Innovation Research (SBIR) Program is partially funding both the trials.