Imara M&A slide image

Imara M&A

ELVN-001 Clinical Development Strategy Phase 1 TRIAL ● ● CP-CML intolerant / resistant T3151 mutation GOALS Demonstrate potential for efficacy superior to 2nd Gen TKIs (at least as good as asciminib & ponatinib) at well tolerated dose(s) Identify dose(s) for Phase 1b and beyond Phase 1b / 2 TRIAL GOALS ● Late line single arm & T3151 single arm Explore based on data (MMR/MR4.5) Earlier lines of therapy Combinations with approved TKIs (e.g., asciminib) ● Establish PoC for deep and durable responses in early line CML Demonstrate efficacy and safety profile suitable for initiating early line H2H CP-CML = Chronic-phase CML. H2H = Head-to-head. MMR = Major molecular response. MR4.5 = Deep molecular response. PoC = Proof of concept Registrational / Phase 3 TRIAL GOALS ● File on 4L+ and T3151 single arm data Initiate early line H2H vs. Physician's Choice ● Accelerated Approval in late line CP- CML Initiate early line H2H for broad label accelerated approval in CP-CML 30
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