Anito-cel Product Profile and Clinical Data - Anito-cel, a BCMA-directed CAR T-cell therapy, utilizes a novel D-Domain binder, potentially offering a best-in-class efficacy profile, differentiated safety, and rapid manufacturing[7, 8, 9, 15] - Phase 1 data showed a median Progression-Free Survival (PFS) of 30.2 months[17] - In the iMMagine-1 pivotal trial, the Overall Response Rate (ORR) was 97%, with a stringent Complete Response/Complete Response (sCR/CR) rate of 68%[92] - iMMagine-1 demonstrated a 6-month PFS rate of 91.9% and a 12-month PFS rate of 79.3%[98] - iMMagine-1 showed a favorable safety profile, with 85% of patients experiencing < Grade 1 Cytokine Release Syndrome (CRS) and 92% experiencing no Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)[17, 108, 118] Market Opportunity and Commercial Strategy - The Multiple Myeloma (MM) CAR T market is projected to reach approximately $12 billion in the 2L+ setting[7, 19, 21, 55, 61] - Arcellx anticipates a high gross margin of ≥70% at launch for anito-cel, with profitability achievable before reaching $1 billion in anito-cel sales[51, 55] - Post-approval, 90% of US Healthcare Professionals (HCPs) are motivated to prescribe anito-cel[30] - Anito-cel is expected to launch with a large Authorized Treatment Center (ATC) network, projected to be 160+ ATCs, leveraging Kite's infrastructure[17, 33, 62] - Payer coverage for anito-cel is projected to be >80% of US lives within 30 days and >90% within 90 days post-launch[45]

Regeneron Pharmaceuticals has won Food and Drug Administration accelerated approval of its Lynozyfic treatment for certain patients with the blood cancer multiple myeloma https://t.co/uOJuKJ92zD ...

A Portfolio Company Corporate Presentation February 2025 1 This Presentation is not an Offer or a Representation. This Presentation does not constitute an offer, or a solicitation of an offer, to buy orsell any securities, investment or otherspecific product, or a solicitation of any vote or approval, norshall there be any sale ofsecurities, investment or otherspecific product in any jurisdiction in which such offer,solicitation orsale would be unlawful priorto registration or qualification underthe securit ...

Sarclisa recommended for EU approval by the CHMP to treat transplant-eligible newly diagnosed multiple myeloma Recommendation based on GMMG-HD7 phase 3 study demonstrating that Sarclisa with VRd induction treatment significantly improved MRD negativity benefit and prolonged PFS compared to VRd aloneIf approved, it would represent the fourth indication in the EU and second in the front-line setting globally Paris, June 23, 2025. The European Medicines Agency’s Committee for Medicinal Products for Human Use ( ...

ASCO: new Sarclisa data support subcutaneous administration with on-body injector New data from two clinical studies demonstrated that Sarclisa administered subcutaneously via an investigational on-body injector shortened treatment time to minutes with similar efficacy and safety compared to intravenous infusionStudies used Enable Injections’ enFuse® on-body injector, an automated hands-free injectorData will form the basis of global regulatory submissions across all currently approved lines of treatment P ...

GSK plc (GSK) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending approval for the Blenrep (belantamab mafodotin) combination therapy to treat relapsed or refractory multiple myeloma.The CHMP recommended the approval of Blenrep in combination with J&J’s Velcade (bortezomib) plus dexamethasone for treating relapsed/refractory multiple myeloma in adult patients who have received at least one prior therapy. The ...

Core Insights - The FDA Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® for treating high-risk smoldering multiple myeloma (HR-SMM), marking a significant step in the treatment landscape for this condition [1][2][3] Company Insights - Johnson & Johnson aims to transform oncology care by advocating for early intervention in high-risk smoldering multiple myeloma, potentially delaying or preventing progression to active multiple myeloma [4][6] - The company emphasizes its commitment to evolving treatment paradigms for multiple myeloma, aligning with its vision for a future where early diagnosis and treatment are standard [4][5] Industry Insights - Currently, there are no approved treatments specifically for HR-SMM, with an estimated 35,000 new multiple myeloma cases expected in the U.S. in 2024, of which approximately 15% are classified as smoldering [3][7] - The standard of care for smoldering multiple myeloma is active monitoring, which may delay therapeutic intervention until significant disease progression occurs [3][8] - The AQUILA study, a Phase 3 trial, demonstrated that early intervention with DARZALEX FASPRO® could reduce the risk of progression or death in patients with HR-SMM [4][6]