Emergent separately confirms start of Phase II study with TRU-016 in CLL patients.
Abbott is terminating its joint development and commercialization agreement with Emergent BioSolutions for the latter’s antibody-based B-cell cancer candidate, TRU-016. It is in clinical trials as a potential treatment for chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL). As a result of the termination, worldwide rights to the drug will be retained by Emergent.
The partnership agreement will remain in effect until March 20, 2012, until which time Abbott will retain its obligations to pay any milestone payments that are triggered in addition to half of the collaboration project costs. The firm will also provide certain forms of transition assistance to Emergent as part of the process of passing back the program.
TRU-016 is a humanized anti-CD37 mono-specific protein therapeutic. Emergent has separately today also announced the start of patient dosing in a Phase II study (trial 16201) evaluating the candidate in combination with bendamustine as a treatment for relapsed CLL. Initiation of this study has triggered a $6 million milestone payment to the firm by Abbott.
Initiation of the Phase II study follows on from an open-label Phase Ib study in 12 patients with relapsed CLL to determine a safe and tolerable dose of TRU-016 in combination with bendamustine. The Phase II portion of the study will evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with bendamustine alone in a total of approximately 100 randomized patients.
The primary endpoint is an overall response rate as defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Secondary endpoints include complete and partial response rates as defined by the 1996 National Cancer Institute criteria, progression-free survival, duration of response, and improvement in quality of life and disease symptoms. TRU-016 is currently also undergoing a Phase Ib study in NHL patients.