Novartis ( NVS ) announced preliminary results from two pivotal trials on its pipeline candidate, CTL019. The results were published in The New England Journal of Medicine .
Novartis is evaluating CTL019, an experimental chimeric antigen receptor (CAR) therapy, for the treatment of pediatric and adult patients suffering from relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
The studies were conducted by Pennsylvania's Perelman School of Medicine (Penn). Results from the studies showed that 27 of 30 pediatric and adult patients with r/r ALL experienced complete remissions with CTL019.
CTL019 uses CAR technology to reprogram a patient's own T cells to look for cancer cells which express certain proteins, which are called CD19. Once reprogrammed, the T cells (called CTL019 after reprogramming) are released into the patient's bloodstream so that they proliferate and bind themselves to the targeted CD19+ cancer cells and destroy them.
We note that Penn has an exclusive global agreement with Novartis to research, develop and commercialize personalized CAR T cell therapies for the treatment of various kinds of cancers.
The FDA granted Breakthrough Therapy Designation to CTL019 in Jul 2014. This is expected to expedite the development and review of the candidate. The designation not only includes all features of the fast track program but a more intensive FDA guidance as well.
We are impressed by Novartis' efforts to realign its portfolio in order to focus on its core business of pharmaceuticals, eye care and generics. The proposed acquisition of the oncology products arm from GlaxoSmithKline ( GSK ) and divestment of its Vaccines business is a step in the right direction. It will broaden the company's portfolio and enable it to focus better on its core capabilities besides contributing immensely to the top line.
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