IDEAYA Biosciences has reported significant progress across its precision medicine oncology pipeline, backed by a strong financial position as it enters 2025. The company's development programs span multiple novel therapeutic approaches, with several key milestones anticipated throughout the year.
Darovasertib Program Shows Continued Momentum
The company's lead program, darovasertib, a potential first-in-class PKC inhibitor, continues to advance in both metastatic uveal melanoma (MUM) and neoadjuvant uveal melanoma settings. Over 230 patients have been enrolled in the potential registration-enabling trial for first-line HLA-A2-negative MUM, with median progression-free survival (PFS) data expected by year-end 2025.
In the neoadjuvant setting, 95 patients were enrolled by the end of 2024, with clinical updates including vision data in plaque brachytherapy patients targeted for the first half of 2025. The company plans to initiate a Phase 3 registration-enabling trial in this indication during the same period.
Promising Early Results for DLL3 TOP1i ADC Program
The recently licensed IDE849 program has shown encouraging preliminary results in small cell lung cancer (SCLC). In early Phase 1 data from China, the drug achieved a 73% overall response rate among 11 evaluable patients, with manageable safety profile predominantly showing Grade 1 or 2 adverse events. Clinical expansion doses have been selected, and the company plans to submit a U.S. IND in the first half of 2025.
MAT2A Inhibitor Program Advances with New Combinations
IDE397, the company's MAT2A inhibitor, is expanding its development program through a collaboration with Gilead Sciences. The combination study with Trodelvy® will evaluate the treatment in both urothelial cancer and non-small cell lung cancer (NSCLC) patients with MTAP deletion. A clinical data update is expected in 2025.
Pipeline Expansion with Novel Candidates
IDEAYA has announced three new development candidates targeting solid tumors:
- IDE892: A PRMT5 inhibitor with IND filing targeted for mid-2025
- IDE034: A first-in-class B7H3/PTK7 TOP1i bispecific ADC planned for IND filing in H2 2025
- IDE251: A novel KAT6/7 dual inhibitor with IND filing expected in H2 2025
Strong Financial Position
The company reported approximately $1.1 billion in cash, cash equivalents, and marketable securities as of December 31, 2024, representing a significant increase from $632.6 million at the end of 2023. This robust financial position is expected to fund operations into at least 2028.
Leadership Expansion
IDEAYA has strengthened its executive team with two key appointments:
- Joshua Bleharski, Ph.D., joins as Chief Financial Officer from J.P. Morgan, bringing extensive biopharma sector experience
- Stu Dorman assumes the role of Chief Commercial Officer, contributing over 20 years of global commercialization experience in oncology
"We are excited to be targeting multiple clinical data readouts and program updates across our clinical pipeline in 2025," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. "The compelling results we've seen across our programs, particularly in neoadjuvant darovasertib and IDE397, position us well for continued progress in developing precision medicine therapeutics."
