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In December 2023, Galapagos NV (Euronext & Nasdaq stock code: GLPG), which reached a licensing collaboration with Shenzhen Pregene Biopharma Co., Ltd., announced that the first patient had been dosed in the PAPILIO-1 Phase 1/2 clinical study for multiple myeloma. PAPILIO-1 is a Phase 1/2 clinical study designed to evaluate the safety, efficacy, and feasibility of GLPG5301, a BCMA CAR-T candidate administered in a continuous seven-day, vein-to-vein, bedside delivery model, for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM).GLPG5301 is a second-generation autologous/4-1BB-targeted B-cell maturation antigen (BCMA) CAR-T candidate drug, administered through a single fixed-dose intravenous infusion of a fresh product, with the treatment model being bedside administration.Jeevan Shetty, Head of Oncology Clinical Development at Galapagos, stated, "The prognosis for patients with relapsed/refractory multiple myeloma (rrMM) is extremely poor, and their need for innovative therapies remains largely unmet, with CAR-T therapy being one of them. We are combining innovative science with the breakthroughs of novel CAR-T therapies and bedside administration to improve patient outcomes and enhance quality of life." "The dosing of the first rrMM patient with GLPG5301 in our PAPILIO-1 clinical trial has been completed, which is a very exciting development and marks another milestone in Galapagos' strategy for bedside administration and CAR-T combination products."This drug is a CAR-T cell therapy targeting the BCMA developed through the authorized collaboration between Pregene and GLPG on September 23, 2022, fully demonstrating Pregene's innovative R&D capabilities on a global scale and high-standard CMC process abilities. In the future, Pregene will continue to work with GLPG to promote in-depth cooperation across all aspects, multiple levels, and wide fields throughout the entire lifecycle of the drug.Galapagos' decentralized, innovative bedside CAR-T production platform includes: the end-to-end xCellit™ workflow management and monitoring software system, a set of decentralized functionally closed automated cell therapy manufacturing platforms (using Lonza’s Cocoon® technology), and its proprietary patented quality control testing and release strategy. These three core technologies make fresh product administration possible, reducing the median vein-to-vein time to 7 days (i.e., the time from patient blood collection to CAR-T reinfusion), while enabling physicians to supervise the entire treatment process with greater detail and comprehensiveness, enhancing their oversight throughout.
Source of the article:Shenzhen Pregene Biopharma Co., Ltd.
