Galapagos needs more speed with its Car

After disappointing with its rheumatoid arthritis drug Jyseleca Galapagos reinvented itself as an oncology Car-T player, and it has just entered phase 3, a new clinicaltrials.gov listing reveals. However, this is probably not the late-stage study investors are looking for – the trial merely involves the long-term follow-up of patients treated with Galapagos’s autologous Car-Ts. Approval in the US still seems some way off; Galapagos’s phase 1/2 studies were being run solely in Europe until August, when the FDA cleared an IND for the Atalanta-1 trial of GLPG5101. The company plans to submit an IND for the Euplagia-1 study of GLPG5201 in the fourth quarter, while a phase 2 EU trial is also in works. Galapagos has previously said it intends to produce one set of globally appropriate trials, and details will be eagerly awaited; the group might not be the force it once was, but it still has a market cap of nearly $2bn. The company is pursuing the usual Car-T targets, but it aims to differentiate with fast manufacturing, claiming a median vein-to-vein time of seven days. However, the importance of speed is still an open question, and Galapagos is late to the game.

Galapagos’s autologous Car-T pipeline

Notes: CLL=chronic lymphocytic leukaemia; CTA=clinical trial agreement; IND=investigational new drug application; NHL=non-Hodgkin lymphoma; RT=Richter transformation. Source: OncologyPipeline.