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news.Emergent BioSolutions that specializes in developing vaccines and therapeutics, has commenced a Phase 2 study of TRU-016 in combination with bendamustine, indicated for the treatment of relapsed chronic lymphocytic leukemia (CLL).
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TRU-016 is a humanized anti-CD37 mono-specific protein therapeutic in development for the treatment of B-cell malignancies.
Emergent will be entitled to a milestone payment of $6m with the commencement of the trial.
The open-label, multi-center, active-controlled trial will enroll bendamustine-naive patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments.
The trial’s Phase 1b portion assessed the tolerable dose of TRU-016 in combination with bendamustine in 12 patients with relapsed CLL.
The primary endpoint for the Phase 1b portion included incidence of dose-limiting toxicities.
Emergent BioSolutions senior vice president and chief medical officer Scott C Stromatt said the combination of bendamustine and TRU-016 has demonstrated increased anti-tumor activity as compared to data when the drug was administered alone.
"The safety data from the Phase 1b portion of the combination trial of TRU-016 with bendamustine in relapsed CLL was recently reviewed by an independent Data Monitoring Committee, and they authorized advancement into Phase 2," Stromatt added.