Imara M&A
ELVN-002 Clinical Focus and Target Product Profile
Our Opportunity
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Target Product Profile
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Drive Durable
Responses
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Well Tolerated
CNS activity
Activity against:
HER2 mutant NSCLC (e.g., Exon 20 IM) and Breast Cancer (e.g., L775)
HER2 amplified and/or overexpressed tumors (breast, CRC, etc.)
Brain metastases
Selective: vs. wild-type EGFR
Safety/tolerability: minimal Gl and skin toxicity (avoid EGFR-tox)
Combinable: with SOC including ADCs across HER2-driven tumors
Convenient: oral QD or BID
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Dose Escalation in solid tumors with
HER2 alterations
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Monotherapy in HER2-driven solid tumors
Evaluate the safety in the combination with ADCs
in HER2+ breast cancer and HER2 mutant NSCLC
Expansion: 2L+ HER2 mutant NSCLC
Single-arm study with potential to support
accelerated approval
Multiple Indication Opportunities
• 1L HER2 mutant NSCLC +/- SOC
Evaluate HER2+ CRC and HER2+ Breast in combination
with SOC
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ADC = Antibody drug conjugate. BID = twice daily. CNS = Central nervous system. CRC = Colorectal cancer. Gl= Gastrointestinal. NSCLC = non-small cell lung cancer. SOC = Standard of care. TKI = Tyrosine kinase inhibitors. QD = once daily
Explore other HER2 mutant solid tumors with
"basket study"
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