Orphan Drug Status for Gastric Cancer Drug

FDA has granted Dewpoint Therapeutics an orphan drug designation for DPTX3186, a first-in-class condensate modulator being developed to treat gastric cancer. The designation comes on the heels of the agency’s recent acceptance of Dewpoint’s IND to launch the first in-human study of a condensate-modulating drug.

DPTX3186 is described as an oral small-molecule condensate modulator that targets the Wnt/β-catenin signaling pathway, a well-known cancer driver. The therapy works by redistributing β-catenin into an inactive condensate state within tumor cells, offering a novel approach that aims to sidestep the safety challenges that have historically limited Wnt inhibition, the company says. Dewpoint says it has also developed a condensate-based biomarker strategy to monitor pharmacodynamic effects directly in patient samples.

The company expects to begin dosing the first patient with DPTX3186 before the end of 2025 at leading U.S. cancer centers.