Dewpoint Therapeutics has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for DPTX3186, a small-molecule condensate modulator for treating gastric cancer.
The company recently opened its investigational new drug application for the oral therapy, marking its entry as a clinical-stage biotech and the beginning of the first human trial involving a condensate-modulating therapeutic.
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Dewpoint research and development chief scientific officer and head Isaac Klein stated: “The FDA’s decision to grant orphan drug designation to DPTX3186 is an extraordinary validation of both the promise of condensate biology and the importance of our work in gastric cancer.
“This recognition reflects the agency’s confidence in our mechanism, our science and our shared goal of bringing new hope to patients facing this devastating disease.”
DPTX3186 works by selectively targeting oncogenic wingless-related integration site/beta (Wnt/β)-catenin signalling through β-catenin redistribution into an inactive condensate state in tumour cells.
The strategy addresses historical safety challenges linked to Wnt inhibition. The clinical programme also integrates a condensate-based biomarker strategy to measure pharmacodynamic outcomes in samples of patients.
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By GlobalDataDewpoint anticipates dosing the first patient with DPTX3186 before the end of 2025 at US cancer centres.
The ODD programme incentivises the development of medicines for rare diseases or conditions that impact fewer than 200,000 individuals in the US.
The designation provides benefits such as seven-year market exclusivity on securing approval, tax credits for approved clinical trials, FDA fee waivers and opportunities for improved regulatory support and expedited review processes.
Dewpoint’s drug discovery pipeline encompasses several therapeutic areas including metabolic diseases, cardiopulmonary conditions, neurodegenerative disorders and oncology.
The company operates through partnerships with Mitsubishi Tanabe Pharma, Bayer and Novo Nordisk.
