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Quick Deep Dive: We Like the STAR Deal, but INCY Valuation Still Full *SLIDES*
研报英文原文证据摘录
Quick Deep Dive: We Like the STAR Deal, but INCY Valuation Still Full *SLIDES*
life limitation
Efficacy looks good: 81% ABR reduction (in naive pts) and 75-100% in switch pts >> comps•
well vs approved tx
PK supports much better dosing vs conventional tx: ~1-mo half-life supports Q4W SC dosing•
Safety something to consider: Safe and well-tolerated so far, but theoretical risk is Protein S•
inhibition LT may increase thrombosis risk.
Exhibit 1 - Competitive Landscape in Von Willebrand (VWD) Prophylaxis (Prophy)
Wilate Vonvendi HMB-002 VGA039
Company Octapharma Takeda Hemab Incyte
US Launch year 2010 2016 In Ph1/2 In Ph3
Target population Broad VWD Broad VWD Broad VWD Severe and persistent bleeding
Clinical trial NCT04053699 and NCT04052698 NCT02973087 NCT06754852 NCT05776069
Monovalent IgG4 antibody that binds VWF CK
VWF/FVIII concentrate replacing deficient VWF Replacement therapy to restore deficient protein domain to protect from clearance and stabilize Fully human IgG4 monoclonal antibody targeting
MoA and stabilizing FVIII to restore hemostasis levels FVIII Protein S to enhance thrombin generation
Median 81%2 ABR reduction in pts w/out prior IV
prophylaxis;
Efficacy (ABR TBD (demonstrated >1.5-fold increase in VWF 75%-100% in pts switching from prior IV
reduction) 84% reduction 92% reduction1 and FVIII levels (clinical benchmark)) prophylaxis
Prophy dosing 2–3 IV infusions per week; On-demand: As
frequency IV 2–3 times per week needed per bleed TBD (from weekly to monthly SubQ) Once-monthly subcutaneous injection
Thrombosis risk (FVIII accumulation),
Safety (pot'l) hypersensitivity, minimal pathogen transmission Generally well-tolerated; primary risks include Elevated D-dimer levels and venous thrombosis Concerns regarding thrombotic risk due to
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