IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update
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IDE397 Phase 1/2 Clinical Development Plan
Comprehensive Approach for Concurrent Evaluation of Monotherapy and Combinations
Phase 1 Dose Escalation and Expansion Strategy
1
IND
Cleared
Monotherapy Dose Escalation
MTAP Deletion in Solid Tumors (e.g., NSCLC, pancreatic, thymic)
FPI
April 2021
Q3 2021
PK/PD Expansion Cohorts 2
IDE397 RDE Mono Expansion in NSCLC (n= 20+)
IDE397 RDE Mono Expansion in EsophagoGastric (n=20+)
IDE397 RDE Mono Expansion in Basket 1 (n= 20+)
IDE397 RDE Mono Expansion in Basket 2 (n= 20+)
Targeting Expansion Cohorts mid-2022
Combo Escalation
(1) Potential Clinical Development Plan for IDE397 subject to ongoing Phase 1 monotherapy dose escalation data, preclinical evaluation, and GSK Opt-In
(2) Tumor Biopsy Cohorts: PK-Pharmacokinetic, PD-Pharmacodynamic
IDE397 + Docetaxel NSCLC (n= 16+)
IDE397 + Paclitaxel EsophagoGastric (n= 16+)
IDE397 + SOC Agent Expansion
IDE397 + NCP
SOC
NCP
Standard of Care
Novel Combination Partner
Preclinical and Early Clinical Data support Clinical Development Focus on NSCLC, Esophagogastric and
Other Solid Tumors such as Head and Neck, Bladder and Pancreatic (e.g., in Potential Basket Cohorts)
gsk
IDEAVA
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