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Arcellx (ACLX) investor relations material
Arcellx Morgan Stanley 23rd Annual Global Healthcare Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key clinical updates and efficacy
Anito-cel demonstrated a complete response rate in the 70% range and 18-month PFS of 66% in late-line multiple myeloma, with MRD negativity in the low 90% range.
No cases of delayed neurotoxicity or immune-related enterocolitis observed with Anito-cel, differentiating it from other BCMA CAR-T therapies.
Additional data with longer follow-up expected at ASH, with median follow-up anticipated to reach 17–18 months.
Market research indicates increasing physician confidence and preference for Anito-cel due to its safety and efficacy profile.
Regulatory and commercialization outlook
Confident in regulatory path for Anito-cel, citing recent single-arm study approvals and strong FDA engagement.
BLA submission expected late 2024 or early 2025, targeting commercial launch in mid to late 2026 in the fourth-line+ setting.
Market opportunity for CAR-T in second-line+ myeloma estimated at $12 billion, with initial focus on a $3.5 billion fourth-line+ segment.
Anticipates rapid adoption in academic and community centers, with market research suggesting up to 80% share in target segment.
Pipeline and platform development
Active trials ongoing in AML and myasthenia gravis, with ARC-SparX platform aiming for universal CAR-T applications.
Myasthenia gravis phase 1 study is enrolling, aiming for durable, treatment-free periods for patients.
ARC-SparX AML program is in phase 1, focusing on optimizing dosing and patient selection.
AI is leveraged to optimize D-domains and binder generation, solving previously intractable problems.
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