Investor Presentaiton
IDE397 Phase 1/2 Clinical Development Plan
Clinical Strategy Focus on Select Monotherapy and High Conviction Combination
IDE397 Development Candidate - Clinical Profile
• Exposure-Dependent Pharmacokinetic (PK) Profile with low Cmax:Cmin
• Robust, Exposure-Dependent Pharmacodynamic (PD) Response
Monotherapy Expansion showing Clinical Efficacy - with Responses in Multiple
High-Priority Tumor Types early in Dose Expansion, including a confirmed PR
IDE397 is uniquely positioned to evaluate efficacy in MTAP pathway,
with a favorable PK/PD profile and observed therapeutic window
Mono Expansion in Select MTAP-null Tumor Histologies
IDE397 RDE Mono Expansion Basket: NSCLC, Esophageal, Gastric, Bladder
Focus or Additional Indication Expansion
Combination Cohorts - Clinical Proof of Concept in MTAP-null Tumors
AMGEN IDE397 + AMG 193 MTA-Cooperative PRMT5i#^: Solid Tumors
Other Potential Indications or Combinations
Addressable Patient Population of ~50,000 estimated in US, EU5 and JP
across priority tumors - NSCLC, bladder, gastric, and esophageal cancers
# AMG193 = Amgen's investigational MTA-cooperative PRMT5 inhibitor
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^ Amgen reported that initial data for AMG 193 monotherapy expansion demonstrated responses in multiple tumor types (See Amgen earnings release and corporate presentation dated August 3, 2023)
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