by Conor
Hale
Aug 23, 2018 10:35am
A discontinued heart disease drug may find new life as a
treatment for sickle cell disease, with Roche handing off development of its
antibody inclacumab to Global Blood Therapeutics.
GBT acquired the worldwide rights to the antibody for $2 million
upfront, and signed on to pay about $125 million down the line, plus royalties,
if inclacumab is approved to treat vaso-occlusive crises, the painful episodes
caused when blood flow is obstructed by sickled red blood cells.
Roche previously completed clinical studies evaluating the
safety and pharmacokinetics of inclacumab in more than 500 patients, but halted
its development in coronary artery disease after a phase 2 trial.
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“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 Love, M.D., president and
CEO of GBT. “Inclacumab is an ideal complement to voxelotor, our lead
investigational oral, once-daily therapy, in phase 3 clinical development for
SCD.”
Inclacumab is a fully human monoclonal antibody antagonist that
targets P-selectin, a cell adhesion protein found lining the walls of blood
vessels and on the surface of activated platelets, helping them act as a
coagulant in cell-cell interactions.
Voxelotor, meanwhile, is being studied as a therapy for the
underlying mechanism of the disease, aiming to help hemoglobin retain more
oxygen and keep red blood cells in their normal shape. The phase 3 trial is
currently enrolling patients.
According to GBT, the South San Francisco-based company has
already begun transferring technology from the Big Pharma to a contract
manufacturing organization and is planning to submit an IND application
for inclacumab to the FDA in 2021 using Roche’s safety data.
Novartis is developing its own anti-P-selectin antibody,
crizanlizumab, for the treatment of vaso-occlusive crises, which it picked up
through a $665 million acquisition of Selexys
Pharmaceuticals in November 2016.
In December of last year, Novartis described how a phase 2 post-hoc
subgroup analysis found crizanlizumab delayed patients’ first on-treatment
sickle cell pain crisis compared to placebo—doubling time to their first event,
if not more, including in patients taking hydroxyurea.
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