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Galapagos pauses blood cancer CAR-T therapy trial due to one Parkinsonism event

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Galapagos has temporarily stopped enrolling patients into an early-phase test in patients with multiple myeloma after a neurological issue was raised. Elsewhere, the biotech expanded its deal with BridGene Biosciences to develop a new cancer drug.

Galapagos hit pause on the Phase 1/2 PAPILIO-1 trial of GLPG5301 in relapsed and refractory multiple myeloma after Parkinsonism was seen in one patient. The Belgian biotech subsequently filed a protocol tweak to the EMA and expects to resume recruitment in the coming months, according to its half-year update released Thursday.

Parkinsonism refers to brain conditions that cause slow movements and tremors, among other symptoms. The PAPILIO-1 trial is designed to study the therapy’s safety and determine the Phase 2 dose.

GLPG5301 is a BCMA-directed CAR-T therapy made using Galapagos’ decentralized manufacturing platform, which would allow for vein-to-vein treatment administration within an average of seven days, according to the company. By contrast, currently marketed CAR-T therapies can take between three and six weeks to make and administer.

Galapagos has two other CAR-T candidates in its pipeline. The most advanced is GLPG5101, which is in Phase 2 for relapsed or refractory non-Hodgkin lymphoma. Slightly behind is GLPG5201 in Phase 1 for chronic lymphocytic leukemia patients with Richter transformation.

Meanwhile, the expanded partnership with BridGene will see the two biotechs work together to discover a selective oral SMARCA2 small molecule proteolysis targeting chimera drug, or PROTAC for short. They will advance the candidate through to preclinical development, according to a separate Thursday release.

Galapagos will get exclusive rights for further development and commercialization. BridGene is eligible for up to $159 million across upfront and preclinical milestone payments as well as clinical and commercial milestones, in addition to tiered royalties on sales.

The two companies first paired up in January to discover small molecule “precision medicines” for cancer. Under that deal, BridGene is due $27 million in upfront and preclinical milestones and more than $700 million in clinical and commercial milestones.

Galapagos said Thursday that it ended June with €3.4 billion ($3.68 billion) in cash and financial investments.


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