Galapagos Says FDA Clears IND Application for Phase 1/2 Cancer Therapy Study

07:00 AM EDT, 08/23/2024 (MT Newswires) -- Galapagos (GLPG) said the US Food and Drug Administration has approved an investigational new drug application for the study of its experimental therapy, GLPG5101, in patients with relapsed/refractory non-Hodgkin lymphoma.

GLPG5101, produced using a decentralized cell therapy manufacturing platform, can potentially administer fresh, fit cells within a median vein-to-vein time of seven days.

The Phase 1 study would assess safety and initial efficacy to determine the recommended dose for Phase 2, while the Phase 2 study would focus on overall response rates and other key outcomes.

The study is underway in Europe, and the company said early data has shown encouraging results in patients with the condition.

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