US FDA Clears Galapagos’ IND Application for Phase 1/2 ATALANTA-1 Study of CD19 CAR-T, GLPG5101

US FDA Clears Galapagos’ IND Application for Phase 1/2 ATALANTA-1 Study of CD19 CAR-T, GLPG5101

By, Admin 27 August 2024

US FDA clears Galapagos’ IND application for phase 1/2 ATALANTA-1 study of CD19 CAR-T, GLPG5101, in relapsed/refractory NHL

Overview

Galapagos NV announced that the US Food and Drug Administration (FDA) has cleared Galapagos’ Investigational New Drug (IND) application for ATALANTA-1, a phase 1/2 multicenter study evaluating the feasibility, safety, and efficacy of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL).

About GLPG5101

GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate produced using Galapagos’ innovative decentralized cell therapy manufacturing platform with the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days.

ATALANTA-1 Trial Objective

  • The primary objective of the phase 1 part of ATALANTA-1 is to evaluate the safety and preliminary efficacy of GLPG5101 to determine the recommended dose for phase 2. 
  • Secondary objectives include assessment of efficacy and feasibility of decentralized manufacturing of GLPG5101. 
  • The primary objective of the phase 2 study is to evaluate the objective response rate. 
  • The secondary objectives include complete response rate, duration of response, progression free survival, overall survival, safety, pharmacokinetic profile, and the feasibility of decentralized manufacturing. 
  • Each enrolled patient will be followed for 24 months.
  • The phase 1/2 ATALANTA-1 study is currently ongoing in Europe, and early data have shown encouraging results in patients with R/R NHL.

Words from the CEO: Galapagos

  • We are dedicated to accelerating breakthrough innovation that extends the reach of cell therapies to patients with rapidly progressing cancers,” said Dr. Paul Stoffels2, Galapagos’ CEO and chairman of the board of directors. 
  • Our innovative, decentralized manufacturing platform is designed to overcome many of the challenges faced by existing CAR-T production methods. The Galapagos platform has the potential for greater speed and scalability, with the delivery of fresh, fit cells with a median vein-to-vein time of seven days, close to patients.
  • The IND clearance for the phase 1/2 study of GLPG5101 marks a significant milestone in our cell therapy clinical program, bringing us one step closer to offering our CD19 CAR-T cell therapy to patients in the US.

About GLPG5101

  • GLPG5101 is a second generation anti-CD19/4-1BB CAR-T product candidate, administered as a single fixed intravenous dose. 
  • It is currently being assessed in the ATALANTA-1 phase 1/2, open-label, multicenter study to evaluate the safety, efficacy and feasibility of decentralized manufactured GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL). 
  • Non-Hodgkin lymphoma is a cancer originating from lymphocytes, a type of white blood cell which is part of the body’s immune system. 
  • Non-Hodgkin lymphoma can occur at any age although it is more common in adults over 50 years old. Initial symptoms usually are enlarged lymph nodes, fever, and weight loss. 
  • There are many different types of non-Hodgkin lymphoma. 
  • These types can be divided into aggressive (fast-growing) and indolent (slow growing) types, and they can be formed from either B lymphocytes (B cells) or in lesser extent from T lymphocytes (T cells) or Natural Killer cells (NK cells). 
  • B-cell lymphoma makes up about 85% of non-Hodgkin lymphomas diagnosed in the US. 
  • Prognosis and treatment of non-Hodgkin lymphoma depend on the stage and type of disease.

Cell Therapy Manufacturing Platform

  • Galapagos’ innovative, decentralized cell therapy manufacturing platform has the potential for the administration of fresh, fit cells within a median vein-to-vein time of seven days, greater physician control and improved patient experience. 
  • The platform consists of an end-to-end xCellit workflow management and monitoring software system, a decentralized, functionally closed, automated manufacturing platform for cell therapies (using Lonza’s Cocoon) and a proprietary quality control testing and release strategy.

About Galapagos

  • Galapagos is a biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. 
  • Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology.

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