IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update
IDE397 Next Steps and Phase 1 Program Summary
Key Upcoming Milestones
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Targeting to deliver GSK Option Data Package Mid-Year 2022
- Potential $50 million Option Exercise Fee
• Targeting to initiate IDE397 Monotherapy Expansion and Combination Escalation Cohorts Mid-Year 2022
- Mono Expansion Cohorts to include NSCLC and Combinations with Taxanes and other Standard of Care Combination Agents
IDE397 Phase 1 Interim Clinical Data Summary
• Favorable PK profile supports acceptable dosing regimen
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No drug-related SAEs observed through Cohort 5 and MTD not yet observed
Robust plasma SAM and exposure dependent tumor pharmacodynamics observed in target tumor types
Cohort 6 enrollment ongoing; first patient cleared without DLT
Favorable Preliminary Risk / Benefit Profile vs. Historical
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IDE397:
Observed preliminary signals of clinical activity, including robust pharmacodynamic modulation and tumor shrinkage
Dose-proportional exposure across all Cohorts 1 through 5 with favorable drug exposure relative to AE profile
MTD not yet observed with no drug-related SAEs through Cohort 5
GSK PRMT5: 26% SAES (53% Grade 3/4) at 400mg QD Expansion Dose (n=19)*
AG-270: 18% Grade 3 or higher AE at 200mg QD Expansion Dose (n=11), and 67% Grader 3 or higher AE at 200mg BID (n=6)**
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* ESMO 2019; ** AACR-NCI-EROTC Triple Meeting, 2019, DCR = Disease Control Rate
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BIOSCIENCES
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