- IND opening marks culmination of partnership between Dewpoint and Evotec, advancing a de novo development candidate through IND-enabling studies
- First patient dosing planned before year-end 2025 at leading cancer centers in collaboration with top key opinion leaders
- Program validates Dewpoint’s condensate-modulator discovery platform and the value of agile, integrated partnerships in accelerating novel drug development
Dewpoint Therapeutics today announced the opening of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for DPTX3186, a first-in-class, only-in-class oral condensate modulator (c-mod) designed to selectively disrupt oncogenic Wnt/β-catenin signaling in tumors. Dewpoint plans to begin dosing its first patient before the end of 2025 in a combined Phase 1/2 trial conducted in partnership with leading cancer centers and key opinion leaders in gastric and other Wnt-driven cancers.
The IND opening marks a significant milestone in Dewpoint’s journey and underscores the strength of its partnership with Evotec, a global drug discovery and development company. Evotec leveraged its deep expertise in drug development to provide integrated support across preclinical, regulatory, and CMC, helping to translate a de novo candidate emerging from Dewpoint’s proprietary c-mod platform into a robust and clinically ready investigational therapy.
“Evotec’s depth of experience and proven track record in advancing first-in-class small molecules through their Evotec INDiGO® platform made them an ideal partner for this effort,” said Ameet Nathwani, Chief Executive Officer of Dewpoint Therapeutics. “Their scientific rigor and development agility were instrumental in helping us take a novel condensate-derived mechanism from concept to IND. For a young biotech company like Dewpoint moving into the clinic for the first time, working alongside a partner of Evotec’s caliber significantly de-risked and accelerated our path to the clinic.”
Discovered and optimized using Dewpoint’s proprietary condensate-modulating drug discovery platform, DPTX3186 uniquely forces β-catenin to concentrate within an inactive condensate inside tumor cells. This novel spatial sequestration mechanism overcomes historic toxicity hurdles that have plagued previous Wnt-targeting approaches. The program is paired with an innovative biomarker strategy tailored to the drug’s condensate-specific mechanism, designed to provide early, precise readouts of pharmacodynamic effect.
“Dosing our first patient this year will be a defining moment for condensate biology and Dewpoint,” said Isaac Klein, MD, PhD, Chief Scientific Officer of Dewpoint Therapeutics. “DPTX3186 is the only molecule of its kind: an oral small-molecule c-mod tackling a historically undruggable pathway with a differentiated safety profile. Its discovery on our platform, the bespoke biomarker strategy, and the caliber of partners supporting this trial reflect the transformative potential of condensate science to rewrite what is possible in drug discovery and development.”
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “Evotec is proud to support Dewpoint in translating an entirely new modality from biology to clinic. The DPTX3186 program exemplifies how next-generation science and disciplined execution must go hand in hand. Dewpoint’s advanced expertise in condensate biology and Evotec’s integrated development platform capabilities have together enabled a smoother, more de-risked path to IND. This project reflects the kind of collaborative, high-science partnerships that will define the future of innovative drug development.”
The initial study will evaluate the safety, pharmacokinetics, and preliminary efficacy of DPTX3186 as a single agent, with a focus on metastatic gastric cancer. Planned expansion cohorts will include combination regimens and additional tumor types. Dewpoint’s strategic collaborations with Bayer, Novo Nordisk, and Mitsubishi Tanabe Pharma, alongside its AI/ML-enabled discovery platform, continue to fuel a pipeline spanning oncology, neurodegenerative, cardiopulmonary, and metabolic diseases.
About Condensates
Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, cardiopulmonary and neurological disorders. Condensate-modulating drugs (c-mods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. Learn more about condensate science at Condensates.com.
For more information, please follow this link to Dewpoint's press release.
About Dewpoint
Dewpoint is a clinical-stage biotech company, leading the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. The realization that a vast range of conditions are regulated by or arise from the dysfunction of condensates has provided new possibilities for modulating the function of high-value targets previously deemed ‘undruggable’, opening unexplored avenues to identify hundreds of novel therapeutic targets. Dewpoint’s proprietary AI/ML-powered state-of-the-art integrated technology underlies a drug discovery pipeline that spans multiple therapeutic areas, including oncology, neurodegenerative, cardiopulmonary, and metabolic diseases. Through collaborations with Bayer, Novo Nordisk, and Mitsubishi Tanabe Pharma Corporation, Dewpoint pushes the boundaries to accelerate the translation of condensate biology into medicine for patients suffering from difficult-to-treat diseases. Learn more at Dewpointx.com and follow us on LinkedIn.
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