Global Blood Therapeutics, Inc. (GBT) has entered into an exclusive worldwide licensing agreement with F. Hoffmann-La Roche Ltd. for the development and commercialization of inclacumab, a novel fully human monoclonal antibody against P-selectin.
GBT plans to develop inclacumab as a treatment for vaso-occlusive crises in patients with sickle cell disease (SCD).
Under the terms of the agreement, GBT will be responsible for all development, manufacturing, and commercialization of inclacumab worldwide. Roche will receive an upfront payment of $2 million from GBT and is eligible to receive up to approximately $125 million in development and commercialization milestone payments for the sickle cell disease indication. Additionally, Roche is eligible to receive tiered royalties based on net revenues for inclacumab.
“We have been working diligently to diversify our product pipeline through both internal research and external business development efforts and are excited to have entered into this agreement for inclacumab,” said Ted W. Love, M.D., president and chief executive officer of GBT, adding that inclacumab complements voxelotor, GBT’s lead investigational oral, once-daily therapy, in Phase 3 clinical development for SCD.
Roche previously was developing inclacumab for patients with coronary artery disease. The pharmacokinetic, safety, and tolerability profile of inclacumab are well characterized based upon Roche’s prior clinical studies, which enrolled more than 500 patients. Roche discontinued the inclacumab program following Phase 2 clinical trials.
P-selectin inhibition is a clinically validated target in SCD, known to reduce the incidence of vaso-occlusive crises. GBT plans to develop inclacumab for this indication and intends to leverage the safety data produced from Roche’s prior clinical studies as it proceeds with development in SCD.
GBT already has begun the process of technology transfer from Roche to a contract manufacturing organization, and anticipates submitting an Investigational New Drug application to the U.S. Food and Drug Administration for inclacumab in 2021.
(Source: Global Blood Therapeutics, Inc.)