IDEAYA Biosciences Gets FDA IND Clearance for IDE849 in Phase 1 Solid Tumor Study

IDEAYA Biosciences, Inc., a company specializing in precision medicine oncology, has announced the approval of their investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). This approval paves the way for the commencement of a Phase 1 clinical trial for IDE849 (SHR-4849), a novel delta-like ligand 3 (DLL3)-targeting antibody drug conjugate (ADC) designed to treat solid tumors.

The new clinical trial aims to explore IDE849's efficacy as a treatment for several types of solid tumors, including small cell lung cancer (SCLC) and neuroendocrine tumors (NETs), where DLL3 is found to be significantly upregulated. IDEAYA's strategy includes using IDE849 not only as a standalone therapy but also in combination with other drugs, notably IDE161, a potential first-in-class inhibitor for poly(ADP-ribose) polymerase (PARG). Preclinical data suggest that combining IDE849 with IDE161 could enhance the durability of the treatment.

Yujiro S. Hata, the President and CEO of IDEAYA Biosciences, expressed enthusiasm about the upcoming Phase 1 trial, emphasizing the potential of IDE849 to target a broad range of DLL3-expressing tumors. Furthermore, Dr. Darrin M. Beaupre, Chief Medical Officer at IDEAYA, highlighted the early clinical validation of IDE849 in SCLC and its potential benefits when used in combination therapies.

Jiangsu Hengrui Pharmaceuticals Co., Ltd., a partner of IDEAYA, is currently conducting an ongoing Phase 1 trial (NCT06443489) across multiple sites. As of December 2024, therapeutic doses of IDE849 have demonstrated positive outcomes, including several partial responses in patients. The trial has reported mostly mild to moderate treatment-related adverse effects, such as reduced white blood cell and platelet counts, and nausea. The trial continues to explore dose escalation, with no severe discontinuations reported so far.

IDEAYA plans to present comprehensive clinical data on IDE849, covering over 40 SCLC patients, at a medical conference scheduled for the third quarter of 2025. The presented data will include insights from both the dose escalation and expansion phases of the trial. Additionally, IDEAYA intends to showcase preclinical data on the synergistic effects of combining IDE849 with IDE161 at the same conference.

The company has identified DLL3 as a promising target due to its limited expression in normal tissues and its upregulation in a variety of solid tumor types, including melanoma and non-small cell lung cancer (NSCLC). This makes IDE849 a potentially significant therapeutic option addressing unmet medical needs in cancer treatment.

IDEAYA is set to launch a global multi-site clinical trial in the latter half of 2025 to evaluate IDE849 as both a monotherapy and in combination with IDE161 across various DLL3-upregulated solid tumors. Following FDA guidance, the U.S. Phase 1 trial will begin with a starting dose equivalent to one of the expansion doses currently under evaluation in Hengrui's ongoing study, where multiple partial responses have been observed.

The company's approach to precision medicine involves leveraging translational biomarkers and drug discovery techniques to tailor therapies to patient populations that are most likely to benefit. IDEAYA's commitment to developing targeted therapies is evident in their focus on synthetic lethality, an emerging area in precision oncology.