Core Insights - Enable Injections, Inc. has received a $30 million investment from Sanofi to enhance its manufacturing capabilities and support commercial growth of the enFuse® On-Body Delivery System [1][2] Company Overview - Enable Injections is a healthcare innovation company based in Cincinnati, focused on developing the enFuse® On-Body Delivery System, which aims to improve patient treatment experiences by delivering large volumes of medications subcutaneously [6][7] - The enFuse system is designed to provide convenient administration of large-volume injectable therapies, particularly in oncology [2][6] Investment and Financials - The recent $30 million investment follows a history of financial support from Sanofi, which previously led a $50 million Series B round in 2018 and participated in a $215 million Series C financing in January 2022 [4] - Enable has also received backing from other institutional investors and organizations, including Cincinnati Children's Hospital Medical Center and Ohio Innovation Fund [4] Manufacturing and Expansion Plans - Enable announced plans for a 90,000 square foot Manufacturing Center of Excellence in Springdale, Ohio, to bolster in-house manufacturing capabilities [5] - The company is committed to enhancing its corporate headquarters in Evendale, Ohio, as part of its commercialization efforts [5] Clinical Trials and Regulatory Status - The enFuse system has been utilized in clinical studies for Sanofi's Sarclisa, with ongoing regulatory reviews for its use in specific formulations [3][7] - The technology received its first combination product U.S. FDA approval in 2023 and has obtained marketing authorizations from several international regulatory bodies [7]

Core Insights - New data from clinical studies support the subcutaneous administration of Sarclisa via an on-body injector, demonstrating non-inferior efficacy and safety compared to intravenous infusion [1][5][6] Group 1: Clinical Study Findings - The IRAKLIA phase 3 study showed very good partial response (VGPR) rates of 46.4% for Sarclisa SC-Pd and 45.9% for Sarclisa IV-Pd, indicating non-inferiority [5] - The objective response rate (ORR) for Sarclisa SC-Pd was 71.1% compared to 70.5% for Sarclisa IV-Pd, establishing non-inferiority [7] - The overall safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower rate of systemic infusion reactions (1.5% vs. 25%) [12][8] Group 2: Patient Experience and Administration - The on-body injector (OBI) is expected to enhance patient experience by providing greater convenience and flexibility, leading to higher patient satisfaction scores [2][9] - 70% of patients treated with Sarclisa SC-Pd reported satisfaction with their injection, compared to 53.4% in the IV-Pd group [12] - The OBI allows for a hands-free administration process, potentially reducing the physical burden on healthcare providers [2][11] Group 3: Future Directions and Regulatory Submissions - Data from the IRAKLIA and IZALCO studies will form the basis for global regulatory submissions for Sarclisa SC administration [6][14] - Sanofi is also exploring Sarclisa SC administration in front-line treatment settings through additional studies [14] - The IRAKLIA study's abstract was selected for the 2025 Best of ASCO program, highlighting its significance in the field [14]

Core Insights - New clinical studies demonstrate the efficacy and safety of Sarclisa administered subcutaneously via an on-body injector (OBI) for relapsed or refractory multiple myeloma (R/R MM) [1][7][10] - The studies presented at the ASCO Annual Meeting show that the OBI method offers non-inferior efficacy compared to traditional intravenous (IV) administration [1][5][10] Study Details - The IRAKLIA phase 3 study is a pivotal non-inferiority trial comparing Sarclisa SC via OBI with Sarclisa IV, both combined with pomalidomide and dexamethasone in adult patients with R/R MM [5][17] - The study reported an overall response rate (ORR) of 71.1% for Sarclisa SC-Pd versus 70.5% for Sarclisa IV-Pd, establishing non-inferiority [8] - The safety profile of Sarclisa SC-Pd was consistent with Sarclisa IV-Pd, with a lower incidence of systemic infusion reactions (1.5% vs. 25%) [9][13] Patient Experience - The OBI is designed to enhance patient comfort and satisfaction, with 70% of patients preferring the OBI over manual injection [13][14] - Patient satisfaction scores were significantly higher for the OBI method, with 74.5% of patients expressing a preference for it [14][15] Future Directions - Sanofi is exploring further applications of Sarclisa SC via OBI in various treatment settings, including front-line therapy for newly diagnosed multiple myeloma patients [15][20] - Data from the IRAKLIA and IZALCO studies will support global regulatory submissions for the OBI delivery method [7][15]