The FDA has granted orphan drug status to AUTO3, a cell-based immunotherapy for the treatment of acute lymphoblastic leukemia (ALL).
AUTO 3
(Autolus Therapeutics) is a programmed T-cell therapy containing two
independent chimeric antigen receptors targeting CD19 and CD22 that are
independently optimized for single-target activity.
“By
simultaneously targeting two B cell antigens, AUTO3 is designed to
minimize relapse due to single antigen loss in patients with B cell
malignancies,” according to a press release from the manufacturer.
“We believe that AUTO3 has the potential to be a best-in-class therapy in pediatric ALL by addressing antigen escape, a common cause of relapse in these patients,” Christian Itin, PhD, CEO
of Autolus, said in a press release. “AUTO3 may also provide an
improved safety profile over currently marketed CAR T therapies with low
levels of severe (cytokine release syndrome) and neurotoxicity observed
in clinical studies.”
AUTO3 is
currently being tested in pediatric patients with ALL as part of the
AMELIA clinical trial and in patients with diffuse large B cell lymphoma
in the ALEXANDER clinical trial.
Data from
the American Cancer Society suggest there will be 5,930 new cases of ALL
and approximately 1,500 deaths in 2019. Sixty percent of cases will be
in patients aged younger than 20 years.
The FDA
Office of Orphan Products Development grants orphan drug designation to
novel drugs and biologics that are intended for the safe and effective
treatment, diagnosis or prevention of rare diseases or disorders that
affect fewer than 200,000 people in the United States. The designation
allows manufacturers to qualify for various incentives, including tax
credits for qualified clinical trials and — upon regulatory approval — 7
years of market exclusivity.
Get to know more about hematology/ oncology by joining us at Rome, Italy, this July, PS: World Hematology 2019
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