IDEAYA Biosciences

IDEAYA Biosciences has received FDA clearance for a Phase 1 clinical trial of IDE849, a potential first-in-class DLL3-targeting Topo-I-payload antibody drug conjugate for solid tumors including small cell lung cancer and neuroendocrine tumors.

• The FDA has granted Breakthrough Therapy designation to darovasertib, a first-in-class protein kinase C inhibitor, for neoadjuvant treatment of primary uveal melanoma patients facing eye removal. • Interim Phase 2 data showed promising results with 82% ocular tumor shrinkage rate and 61% eye preservation rate in uveal melanoma patients, addressing a significant unmet need with no FDA-approved systemic therapies. • IDEAYA Biosciences plans to initiate a Phase 3 randomized registrational trial in neoadjuvant uveal melanoma in the first half of 2025, targeting approximately 12,000 patients annually across North America, Europe, and Australia.

IDEAYA Biosciences and GSK will present promising data on IDE275 (GSK959), a potential best-in-class Werner Helicase inhibitor for MSI-H solid tumors, at AACR 2025's New Drugs on the Horizon series.

• IDEAYA Biosciences has formed a strategic collaboration with ATTMOS to develop a physics-based computational platform for discovering small molecule drugs targeting previously undruggable oncology targets. • The partnership will focus on implementing high-throughput absolute binding free energy perturbation predictions (ABFEP) to enable more accurate and efficient virtual screening of drug candidates. • The collaboration leverages IDEAYA's expertise in structural biology and drug discovery combined with ATTMOS's computational chemistry capabilities to overcome current limitations in AI/ML approaches for novel drug targets.

• Amgen and Ideaya Biosciences have mutually agreed to discontinue their clinical collaboration testing the combination of AMG 193 and IDE397 for solid tumors. • Ideaya will pivot to studying IDE397 in combination with its own PRMT5 inhibitor IDE892 for non-small cell lung cancer treatment. • Amgen continues development of AMG 193 monotherapy, which showed 21.4% objective response rate across multiple tumor types, and has initiated Phase II trials in NSCLC.

IDEAYA Biosciences advances multiple oncology programs, with over 230 patients enrolled in potential registration-enabling trial for darovasertib in metastatic uveal melanoma, targeting key readouts by end of 2025.

• IDEAYA Biosciences and Amgen have mutually agreed to terminate their clinical combination study of IDE397 and AMG 193, leading Oppenheimer to reduce IDEAYA's price target to $40 from $53. • Despite the setback, IDEAYA remains committed to the therapeutic pathway and is strengthening its partnership with Gilead for Trodelvy while advancing their proprietary PRMT5 candidate. • Oppenheimer maintains an Outperform rating on IDEAYA shares, noting that the 2023 preclinical data was among the most impressive they had observed.

IDEAYA Biosciences has a strong financial position with $1.2 billion in cash, expected to fund operations into at least 2028.

• IDEAYA Biosciences has secured an exclusive license from Hengrui Pharma for SHR-4849, a DLL3-targeting antibody-drug conjugate (ADC), outside of Greater China. • SHR-4849 is currently in Phase 1 trials and has demonstrated promising antitumor activity in preclinical studies, particularly in small cell lung cancer (SCLC). • The agreement includes a $75 million upfront payment to Hengrui, with potential milestone payments reaching up to $1.045 billion, plus royalties on net sales. • IDEAYA plans to file a US IND for SHR-4849 in the first half of 2025, with potential for combination therapies with its PARG inhibitor IDE161.

• IDEAYA Biosciences' combination therapy of darovasertib and crizotinib receives IDMC recommendation to advance to Part 2b of Phase 2/3 trial. • The trial focuses on first-line treatment for HLA-A2-negative metastatic uveal melanoma (MUM) and has enrolled over 185 patients. • FDA has granted Fast Track designation to the combination therapy, potentially expediting its development and review process. • The study aims for accelerated approval based on median progression-free survival, addressing a significant unmet need in MUM treatment.