IDEAYA Biosciences (IDYA) 44th Annual J.P. Morgan Healthcare Conference summary

Strategic Focus and Research Vision

• Aims to lead in precision medicine oncology with first- and best-in-class programs targeting solid tumors, leveraging predictive biomarkers, AI-driven drug discovery, and rational combinations.

• Four clinical pipeline areas: darovasertib, ADCs/DNA damage repair, MTAP deletion, and tumor heterogeneity, each targeting significant unmet needs in oncology.

• Six internally discovered clinical-stage molecules address challenging targets like helicases and polymerases, with a total of nine clinical-stage molecules focused on first-in-class targets and precision medicine.

• Drug discovery platform integrates CRISPR, chemigenomics, and computational design for accelerated IND delivery.

• Focuses on neoadjuvant/adjuvant indications, 1L metastatic disease, and synthetic lethality pathways.

Clinical Pipeline and Development Highlights

• Darovasertib targets uveal melanoma across all disease stages, with pivotal Phase 2/3 trials in metastatic and neoadjuvant settings and key milestones in 2026-2027.

• IDE849 (DLL3 ADC) and IDE161 (PARG inhibitor) are being developed for synergistic use in DLL3+ tumors, including SCLC and NEC.

• IDE397 (MAT2A inhibitor) forms the backbone for MTAP-deleted tumor strategies, with combinations in urothelial and lung cancers.

• Next-generation therapies in Phase 1 include IDE275 (WRN inhibitor for MSI-H cancers) and IDE574 (KAT6/7 inhibitor for breast/lung cancers).

• Pipeline enables wholly owned combinations across key pathways and multiple solid tumor indications, such as uveal melanoma, lung, colorectal, and breast cancers.

Key Clinical Data and Efficacy

• Darovasertib + crizotinib showed a 34.1% ORR and 90.2% DCR in metastatic uveal melanoma, with median OS of 21.1 months, outperforming historical controls.

• Demonstrated significant efficacy: 35% response rate, 9-month median duration, 7-month PFS, and 21+ month OS in metastatic uveal melanoma.

• IDE849 (DLL3 TOPO-ADC) showed up to 80% ORR and 100% DCR in SCLC Phase 1, with >6 months PFS and plans for a registrational monotherapy study.

• IDE397 + Trodelvy in MTAP-deleted urothelial cancer achieved up to 57% ORR at higher dose levels.

• Early data show ~40% response rate in MTAP-deleted tumors, with some patients exceeding 200 days of response.