California-based biopharmaceutical company, GBT, Inc. (Global Blood Therapeutics) has reportedly entered into an exclusive global licensing agreement with F. Hoffmann-La Roche Ltd. to develop and commercialize a novel monoclonal antibody that fights P-selectin.
The antibody reportedly called inclacumab will be developed by GBT to treat vaso-occlusive crises in individuals suffering from the sickle cell disease (SCD). If reports are to be believed, under the terms of the license agreement the company will be responsible for developing, manufacturing and commercializing inclacumab worldwide. GBT will reportedly pay Roche an upfront sum of $2 million.
Roche is also reportedly eligible to get up to $125 million approximately upon the achievement of development and commercialization milestones and is entitled to get tiered royalties depending upon inclacumab revenues as well.
GBT President and CEO, Ted W. Love, M.D., stated that GBT has been tirelessly working to diversify its product pipeline through internal as well as external business efforts. Love further added that GBT is thrilled to obtain the inclacumab license as the antibody compliments the company’s voxelotor – an investigational, once-daily oral therapy lead by GBT – in SCD’s phase 3 clinical development.
Supposedly, inclacumab was previously being developed by Roche for individuals suffering from coronary artery disease. The tolerability, safety and the pharmacokinetic profile of inclacumab is well described by prior clinical studies carried out by Roche that discontinued the program after phase 2 clinical drug trials.
GBT reportedly intends to develop inclacumab further to inhibit P-selectin as it is a medically validated target of SCD and is known to increase vaso-occlusive crises if left uninhibited. GBT will seemingly be leveraging Roche’s previous clinical studies data as it moves further with development in SCD.
According to reports, GBT has already initiated the technology transfer process from Roche to a contract manufacturing organization. The company is contemplating to submit an Investigational New Drug application for inclacumab to the U.S. FDA (Food and Drug Administration) by 2021.
