Protocols

Case Western/Sangamo get $11M grant to wipe out HIV; Sage’s depression drug, GSK’s vaccine get breakthrough therapy designation

→ Private university Case Western Reserve and Sangamo Therapeutics $SGMO have scored an $11 million grant from the National Institutes of Health to study gene-edited T cells that would completely wipe out HIV. The grant will fund a clinical trial testing the hypothesis that treating patients with their own gene-edited T cells may lead to a sustained boost in T cell counts and the eradication of latent HIV reservoirs. Current treatments for HIV don’t cure infected people due to the persistence of a latent HIV population, the companies said in a joint statement. Sangamo Therapeutics will be contributing materials, equipment, and manufacturing expertise for the study, which is expected to begin in 2018.

Sage Therapeutics $SAGE has long touted the blockbuster potential of SAGE-217 in depression; now it has a breakthrough therapy designation from the FDA to back that up. The decision was based primarily on a Phase II trial of the oral drug, which involved 89 patients with major depressive disorder.

→ The FDA has granted breakthrough therapy designation to the meningitis B vaccine GlaxoSmithKline is developing, this time for use in children 2 to 10 years of age. This is the second BTD the vaccine, Bexsero, has received: It had garnered that status for the same indication but a different age group in 2014, then swiftly approved in 2015. According to the pharma giant, this new breakthrough is important because 35% of all meningitis B cases in the US occur in children under 11 years old.


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