Emergent BioSolutions, Inc., announces Phase Ib/II studies in fight against chronic lymphocytic leukemia

The Rockville, Maryland-based Emergent BioSolutions, Inc., recently announced the commencement of Phase Ib/II studies of TRU-016, its candidate to help in the fight against chronic lymphocytic leukemia.

TRU-016, developed in collaboration with Abbott, is a CD37-directed Small Modular ImmunoPharmaceutical protein therapeutic developed for the treatment of B-cell malignancies.

The open-label, multi-center, active-controlled study is expected to use up to 114 patients that are bendamustine-naïve. The patients are all expected to have a confirmed diagnosis of chronic lymphocytic leukemia and have failed three previous treatments.

The Phase Ib portion of the study will aid in determining a safe and tolerable dose of TRU-016 in combination with bendamustine. Up to 14 patients will be used, all of whom have chronic lymphocytic leukemia. The primary constraint of the study will be the incidence of dose-limiting toxicity during treatment.

The phase II portion of the study will look at TRU-016’s safety and efficacy when used in combination with bendamustine in comparison with standalone treatments with bendamustine. One hundred randomized patients will be used.

The endpoints on the phase II portion of the study will be the overall response rate as defined by the criteria of the 2008 International Workshop on Chronic Lymphocytic Leukemia.

“Given the strong TRU-016 preclinical combination data, and the positive clinical results from the single agent dose escalation study, we believe human clinical evaluation of TRU-016 in combination with bendamustine could yield meaningful results,” Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions, Inc., said.