Imara M&A
ELVN-001 Clinical Focus and Target Product Profile
Our Opportunity
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Target Product Profile
Drive Deeper
Responses
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Improve
Tolerability
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Enhance Safety
& Convenience
High selectivity vs. clinically relevant off-targets
Efficacy: MMR (& MR4.5) greater than approved TKIs driven by an
enhanced therapeutic window
Tolerability: fewer dose reductions & discontinuations
Safety: No black box warnings; no edema, effusions, or rash
• No restrictions with concomitant medications
Activity against native BCR-ABL and T3151 mutation (& known asciminib
resistant mutations)
CCYR Complete cytogenetic response. CP-CML = Chronic phase CML. H2H = Head-to-head. LoT = Line of therapy. MMR = Major molecular response. MR4.5 = Deep molecular response. TKI = Tyrosine kinase inhibitors
Dose Escalation in 3L+ and Expansion
Progressed/Intolerant CP-CML
Explore early LoT & combinations
Seek to demonstrate improved efficacy
(CCYR, MMR, MR4.5) and tolerability
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4L+ and T3151 mutation
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Single-arm study; precedent for approval in last line
based on CCYR/MMR by 12m
T3151 mutation in ponatinib or asciminib
progressed/intolerant/ineligible
Early Line H2H vs Physician's Choice
Superiority based on 12m MMR in CP-CML
• Fewer dose reductions/discontinuations vs. approved
agents
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