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July 7, 2022

Glioblastoma trial of Biohaven, Vigeo candidates initiates

The GBM AGILE trial will evaluate multiple treatments for patients who are recently diagnosed and have recurrent glioblastoma.

The Global Coalition for Adaptive Research (GCAR), Biohaven and Vigeo Therapeutics have commenced the Glioblastoma Adaptive Global Innovative Learning Environment (GBM AGILE) trial of Biohaven’s troriluzole and Vigeo’s VT1021.

The orally administered small molecule, troriluzole modulates glutamate, which is the most abundant excitatory neurotransmitter in the human body.

For GBM AGILE trial, the drug was selected based on compelling evidence showing glutamate deregulation in glioblastoma.

Vigeo’s VT1021 is a first-in-class dual modulating compound which blocks the immune checkpoint of CD47 and activates the apoptotic and macrophage reprogramming activity of CD36.

The revolutionary patient-centred, adaptive platform GBM AGILE trial has been designed to evaluate multiple treatments for patients who are recently diagnosed and have recurrent glioblastoma (GBM), which is the deadliest form of brain cancer.

Initially, the trial was opened in July 2019 and has screened more than 1200 patients till date.

Conducted under a master protocol, the GBM AGILE trial allows multiple therapies or combination therapies from different pharmaceutical partners to be simultaneously evaluated. 

GBM AGILE Arm Identification and Selection Committee member Dr Michael Lim said: “GBM AGILE is a ground-breaking trial that enables us to simultaneously and dynamically study the effects of multiple new drug candidates in an optimized learning environment.

“The trial’s nimble model allows us to more efficiently and rapidly identify effective therapies for GBM patients.

“We are excited to include troriluzole and VT1021 in GBM AGILE. These investigational drugs have the potential to support improved outcomes for GBM patients, who desperately need more effective treatment options.”

The data obtained from the trial can be used as the foundation for biologics license application (BLA) and new drug application (NDA) submissions and registrations to the FDA as well as other health authorities.

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