Emergent BioSolutions Inc. today announced the initiation of a Phase Ib/II study (16201) of TRU-016 for chronic lymphocytic leukemia (CLL). TRU-016 is a CD37-directed Small Modular ImmunoPharmaceutical (SMIP?„?) protein therapeutic in development for the treatment of B-cell malignancies. TRU-016 is being developed in collaboration with Abbott.
The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.
"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," said Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions. "The dose escalation study in CLL continues to demonstrate that TRU-016 is well tolerated and clinically active and we look forward to Phase I combination data from this study, as well as the planned Phase I combination study for follicular Non-Hodgkin’s Lymphoma."
Additional information about this Phase Ib/II clinical study can be found on http://www.clinicaltrials (protocol 16201).
SOURCE Emergent BioSolutions Inc.