Galapagos Secures FDA IND Clearance for GLPG5101 CAR-T Study
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FDA Clearance for Galapagos' IND Application
Galapagos NV (Euronext & NASDAQ: GLPG) has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application pertaining to the ATALANTA-1 study. This Phase 1/2 multicenter study is designed to evaluate the feasibility, safety, and efficacy of GLPG5101 in patients diagnosed with relapsed/refractory non-Hodgkin lymphoma (R/R NHL).
Introduction to GLPG5101
GLPG5101 is a revolutionary product candidate in the form of an autologous CD19 CAR-T cell therapy. It is produced utilizing Galapagos’ decentralized cell therapy manufacturing platform. This innovative platform facilitates the administration of fresh, optimized cells to patients with a remarkably short median vein-to-vein time of just seven days.
Objectives of the ATALANTA-1 Study
The ATALANTA-1 study has clear objectives delineated by its Phase 1 and Phase 2 components. The primary goal of the Phase 1 portion is to assess the safety and preliminary efficacy of GLPG5101, helping to determine the optimal dose for the subsequent Phase 2 study. The secondary objectives extend to evaluating the efficacy and feasibility of decentralized methods in manufacturing GLPG5101. In the Phase 2 part of the study, the primary focus will be on the objective response rate, while secondary objectives will include assessments of complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetic profiling, and the practicalities of decentralized manufacturing processes. Each patient participating in the study will be monitored for a duration of 24 months.
Progress and Preliminary Insights
Currently, the Phase 1/2 ATALANTA-1 study is actively ongoing in European locations. Early data emerging from the study indicates promising outcomes for patients suffering from R/R NHL, showcasing the potential of GLPG5101 to significantly impact treatment pathways.
Significance of Decentralized Manufacturing
The novel, decentralized cell therapy manufacturing platform from Galapagos aims to improve the overall patient experience, allowing for better physician control and enhanced operational efficiencies. This platform includes an innovative end-to-end xCellit® workflow management system, which is integrated with a functionally closed, automated manufacturing process using advanced technologies such as Lonza’s Cocoon®. Furthermore, it employs a proprietary quality control strategy that ensures the highest standards in product integrity and patient safety.
Corporate Commitment to Quality and Innovation
Galapagos is resolute in its commitment to addressing significant medical needs through the development of pioneering therapies. With a focus on oncology and immunology, the company employs a cohesive strategy that combines innovative science and technology. Their extensive pipeline covers a spectrum of therapies with an emphasis on small molecules and cell-based innovations. With operational capabilities ranging from lab research to patient administration, Galapagos aims to redefine healthcare delivery and enhance outcomes for patients and stakeholders alike.
Understanding Non-Hodgkin Lymphoma
Non-Hodgkin lymphoma (NHL) originates from lymphocytes, crucial components of the immune system. It can manifest at any age but is most prevalent among individuals over 50. Patients frequently present with symptoms such as swollen lymph nodes, fever, and weight loss. Non-Hodgkin lymphoma encompasses numerous subtypes, which are further categorized into aggressive and indolent forms, predominantly arising from B lymphocytes but also from T lymphocytes and Natural Killer (NK) cells. Approximately 85% of cases reported in the U.S. involve B-cell lymphoma.
Company Contact Information
For media inquiries, contact:
Marieke Vermeersch
+32 479 490 603
media@glpg.com
Jennifer Wilson
+44 7444 896759
media@glpg.com
For investor inquiries, reach out to:
Sofie Van Gijsel
+1 781 296 1143
ir@glpg.com
Sandra Cauwenberghs
+32 495 584 663
ir@glpg.com
Frequently Asked Questions
What is the GLPG5101 therapy?
GLPG5101 is an autologous CD19 CAR-T cell therapy developed by Galapagos, aimed at treating relapsed/refractory non-Hodgkin lymphoma.
What is the objective of the ATALANTA-1 study?
The ATALANTA-1 study aims to evaluate the safety, efficacy, and manufacturing feasibility of GLPG5101 in potential patients.
What are the expected outcomes of the Phase 1 study?
Primary outcomes will focus on safety and preliminary efficacy to determine the recommended dose for the Phase 2 segment of the study.
How does Galapagos ensure effective manufacturing of CAR-T therapies?
Galapagos utilizes a decentralized manufacturing platform that allows fresh cell delivery within a median vein-to-vein time of seven days.
What is the broader goal of Galapagos as a biotechnology company?
Galapagos aims to develop transformative therapies targeting high unmet medical needs while enhancing the quality of life for patients.
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