Ideaya Biosciences' IDE397 Shows Preliminary Tolerability In Early-Stage Solid Tumor Trial

IDEAYA Biosciences Inc IDYA has announced interim Phase 1 data for IDE397 in patients with solid tumors with methylthioadenosine phosphorylase (MTAP) deletion, estimated to represent approximately 15% of solid tumors.

• The observed steady-state plasma SAM exceeds the target of >60% reduction of plasma S-adenosyl methionine (SAM), a proximal PD biomarker of target engagement, across all evaluated cohorts. 
• Cohort 5 showed a mean 77% reduction of steady state plasma SAM compared to baseline. 
• Treatment with IDE397 in Cohort 5 resulted in a 95% reduction of tumor symmetric dimethyl arginine (SDMA) in a non-small cell lung cancer, a tumor PD biomarker.
• No drug-related Serious Adverse Events were observed.
• Also Read: Ideaya Reports New Data From Combo Therapy Regime In Pretreated Eye Cancer Patients.
• IDEAYA is targeting monotherapy cohort expansion and initiation of combination cohorts mid-year 2022.
• IDEAYA is leading R&D of IDE397 through early clinical development, in collaboration with GlaxoSmithKline Plc GSK.
• If GSK elects to opt-in, IDEAYA will receive a $50 million option exercise payment, with ongoing development cost-sharing of 80% GSK / 20% IDEAYA and milestone payments of $465 million.
• The Company ended 2021 with cash, cash equivalents, and marketable securities of $368.1 million, sufficient to fund its planned operations into 2025.
• Price Action: IDYA shares closed 4.92% lower at $12.17 on Monday.