10:23 AM EDT, 05/06/2025 (MT Newswires) -- IDEAYA Biosciences ( IDYA ) said Tuesday that the US Food and Drug Administration has accepted an investigational new drug application for the initiation of a phase 1 clinical trial to evaluate IDE849 (SHR-4849), a potential delta-like ligand 3-targeting topo-I-payload antibody drug conjugate program in solid tumors.

The DLL3 is upregulated in solid tumor types, including small cell lung cancer, neuroendocrine tumors, non-small cell lung cancer and melanoma, among other solid tumors, the company's president and chief executive officer Yujiro Hata said.

IDE849, which is in an ongoing multi-site open label phase 1 clinical trial for advanced solid tumors by Jiangsu Hengrui Pharmaceuticals, has reached therapeutic dose levels, the company said.

As of the data cut-off date Dec. 10, 2024, treatment related adverse events were predominantly grade 1 or 2, and the phase 1 dose escalation is ongoing with no reported drug-related discontinuations, and the maximum tolerated dose has not yet been reached. Jiangsu Hengrui is looking to release clinical efficacy and safety data on IDE849 during the third quarter.

IDEAYA Biosciences ( IDYA ) is also planning to present preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based antibody drug conjugates in the third quarter.

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