Shares of Galapagos NV GLPG, a clinical-stage company, are rising in the premarket hours on Aug 23, after the FDA cleared its investigational new drug application to begin an early to mid-stage study of GLPG5101 in patients with relapsed/refractory non-Hodgkin lymphoma (R/R NHL).

GLPG5101 is an autologous CD19 CAR-T cell therapy product candidate, which is administered as a single, fixed, intravenous dose. It has been developed utilizing Galapagos’ proprietary decentralized cell therapy manufacturing platform.

The planned phase I/II ATALANTA-1 study will evaluate the feasibility, safety and efficacy of GLPG5101 for the R/R NHL indication in the United States. Please note that the ATALANTA-1 study is currently ongoing in the EU for the same indication, and early data from the study have shown encouraging results.

The main goal of the phase I portion of the ATALANTA-1 trial is to assess the safety and initial effectiveness of GLPG5101 to establish the appropriate dosage strength for the phase II portion. Additionally, the phase I portion will also evaluate the efficacy and feasibility of decentralized manufacturing of GLPG5101 as a secondary objective.

On the other hand, the primary goal of the phase II portion is to assess the objective response rate, while secondary goals include evaluating the complete response rate, duration of response, progression-free survival, overall survival, safety, pharmacokinetics and the feasibility of decentralized manufacturing. The treatment period for all enrolled patients will be 24 months. Year to date, shares of GLPG have plunged 38.8% against the industry’s 1.6% growth.

Image Source: Zacks Investment Research

Per Galapagos, NHL is a type of cancer that originates in the lymphatic system, which is part of the body’s immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell that plays a crucial role in fighting infections. All age groups are susceptible to NHL, although it most commonly occurs in adults more than 50 years of age. NHL is broadly classified into two types — aggressive (fast-growing) and indolent (slow-growing).

Galapagos has a deep pipeline of best-in-class small molecules and cell therapies in oncology and immunology. Under oncology, apart from GLPG5101, the company is currently evaluating two other candidates in separate clinical studies for leukemia and myeloma. Under immunology, Galapagos is developing investigational TYK2 inhibitor, GLPG3667, in separate mid-stage studies to treat lupus and dermatomyositis.

Galapagos NV Price and Consensus

Galapagos NV price-consensus-chart | Galapagos NV Quote