Imara M&A slide image

Imara M&A

Tumor Volume (mm³) ELVN-002 Demonstrated Robust Anti-Tumor Activity in Beas2b HER2 YVMA Xenograft Model at Well-Tolerated Doses 4000- 3000- 2000- 1000- 0 ● ● Beas2b HER2 YVMA Xenograft TGI 5 10 Days post treatment 15 20 Vehicle BID = Twice a day. MTD = Maximum tolerated dose. TGI = Tumor growth inhibition. QD = Once a day Tucatinib 300 mg BID (tablet) human AUCtau ~5,234 ng*hr/mL (NDA); mouse 100 mg/kg AUC ~143,600 ng*hr/mL (internal data) Pozi 16 mg human AUC ~450 ng*hr/mL (Spectrum website); mouse 1 mg/kg AUC ~3,500 ng*hr/mL (internal data) Tucatinib 100 mg/kg QD Poziotinib 1 mg/kg QD ENLV-002 5 mg/kg QD ENLV-002 10 mg/kg QD ENLV-002 20 mg/kg QD Beas2b HER2 YVMA Xenograft Body Weight Change Body Weight (% of starting weight) 120 110- 100- 90 80- 70- 0 JOK 3/8 mice required dose holiday(s) starting day 11 5 10 Days post treatment 15 Poziotinib's MTD in this model was 1 mg/kg, and this dose yielded an exposure ~8x its human exposure at 16 mg QD ELVN-002 yielded deep tumor regressions, and all doses tested were well-tolerated Minimal TGI vs. YVMA observed with tucatinib treatment up to ~14x its human exposure at 300 mg BID 20 Vehicle ELVN-002 20 mg/kg QD Tucatinib 100 mg/kg QD Poziotinib 1 mg/kg QD 40
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