FDA Approves IND for Galapagos' Phase 1/2 ATALANTA-1 CD19 CAR-T Study in Non-Hodgkin Lymphoma

On August 23, 2024, Mechelen, Belgium-based biotech company Galapagos NV (Euronext & NASDAQ: GLPG) received approval from the U.S. Food and Drug Administration (FDA) to proceed with their Investigational New Drug (IND) application for the ATALANTA-1 study. This Phase 1/2 multicenter clinical trial will investigate the feasibility, safety, and efficacy of GLPG5101, a novel CD19 CAR-T cell therapy, in patients suffering from relapsed or refractory non-Hodgkin lymphoma (R/R NHL).

GLPG5101 is an innovative autologous CD19 CAR-T cell therapy developed using Galapagos' decentralized cell therapy manufacturing platform. This platform potentially allows the administration of fresh cells within a median vein-to-vein time of seven days, offering a significant advantage over traditional methods.

The ATALANTA-1 trial is divided into two phases. The initial Phase 1 aims to assess the safety and preliminary efficacy of GLPG5101 to establish the recommended dosage for the subsequent phase. Additional objectives include evaluating the feasibility of decentralized manufacturing. Phase 2 will focus on measuring the objective response rate while also considering other outcomes like complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetics, and the feasibility of decentralized manufacturing. Each patient enrolled in the study will be monitored for a period of 24 months.

The ongoing ATALANTA-1 study in Europe has already shown promising early results in patients with R/R NHL. Dr. Paul Stoffels, the CEO and Chairman of Galapagos, emphasized the company's commitment to advancing cell therapies for rapidly progressing cancers. He highlighted that their decentralized manufacturing platform aims to overcome many challenges associated with existing CAR-T production methods, offering greater speed and scalability and enabling the delivery of fresh, fit cells close to patients.

Non-Hodgkin lymphoma (NHL) is a type of cancer originating from lymphocytes, a form of white blood cell integral to the immune system. NHL can occur at any age but is more prevalent in adults over 50. Common initial symptoms include enlarged lymph nodes, fever, and weight loss. NHL is classified into aggressive (fast-growing) and indolent (slow-growing) types, and it can arise from B cells, T cells, or Natural Killer (NK) cells, with B-cell lymphoma making up approximately 85% of NHL cases diagnosed in the United States. The prognosis and treatment of NHL depend on the specific type and stage of the disease.

GLPG5101 is a second-generation anti-CD19/4-1BB CAR-T product candidate administered as a single intravenous dose. It is currently under investigation in the ATALANTA-1 Phase 1/2, open-label, multicenter study to evaluate its safety, efficacy, and the feasibility of decentralized manufacturing in patients with R/R NHL.

Galapagos’ innovative decentralized cell therapy manufacturing platform aims to enhance the patient experience by allowing for the administration of fresh cells within seven days. The platform includes a comprehensive xCellit® workflow management and monitoring software system, a functionally closed, automated manufacturing platform (using Lonza’s Cocoon®), and a proprietary quality control testing and release strategy.

Galapagos NV is a biotech company with operations in Europe and the U.S., dedicated to developing transformative medicines that enhance both the lifespan and quality of life. The company focuses on areas with high unmet medical needs, leveraging robust science, technology, and collaborative approaches to develop a strong pipeline of small molecules and cell therapies in oncology and immunology. With comprehensive capabilities from laboratory research to patient treatment, Galapagos is committed to challenging the status quo and delivering meaningful outcomes for patients, employees, and shareholders.