IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update
IDE397 Preclinical and Clinical Pharmacodynamic Data Summary
Robust Plasma SAM and Exposure-Dependent Tumor SDMA Biomarkers
Preclinical & Interim Phase 1 Clinical Data
Preclinical
IDE397 at 30mg/kg demonstrates regressions with
observed ~80-100% tumor SDMA reduction in multiple
MTAP-deleted in vivo PDX models
Interim Phase 1 Clinical Data
IDE397 achieves targeted plasma SAM reduction of >60%
across all Phase 1 doses of Cohort 1 through Cohort 5
IDE397 demonstrates exposure-dependent tumor
pharmacodynamic data in target tumor types, including
~95% reduction of tumor SDMA in Cohort 5
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IDEAYA Data
PK/PD AUC Comparing Preclinical to Clinical Experience
AUC SS
1
7.8 x
Mouse 30 mg/kg
H838 TGI 101%
SDMA reduction 99%
Human (NSCLC)
Cohort 5 C1D15
5.2 x
Mouse 10 mg/kg
H838 TGI 94%
2.6 x
Human (pancreatic)
Cohort 4 C1D15
Mouse 3 mg/kg
H838 TGI 80%
SDMA reduction 70%
Human (pancreatic)
1.0 x
Cohort 3 C1D15
Mouse 1 mg/kg
H838 TGI 60%
1 AUCss values normalized to Cohort 3 value
gsk
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