Emergent BioSolutions, Inc., initiates Phase 2 study of TRU-016

Emergent BioSolutions, Inc., has initiated a Phase 2 study of TRU-016 in combination with bendamustine for patients with relapsed chronic lymphocytic leukemia.

A $6 million milestone payment to Emergent BioSolutions was triggered by the initiation of the clinical trial for TRU-016, which is a humanized anti-CD37 mono-specific protein therapeutic in development for the treatment of B-cell malignancies.

“Preclinical studies have demonstrated increased anti-tumor activity for the combination of bendamustine and TRU-016 beyond the results achieved when either drug was administered alone,” Scott C. Stromatt, the senior vice president and chief medical officer at Emergent BioSolutions, Inc., said. “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.”

The open-label, multi-center, active-controlled study is enrolling bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL who have failed up to three previous treatments.

Twelve patients with relapsed CLL were evaluated in the Phase 1b portion of the study to determine a safe and tolerable dose of TRU-016 in combination with bendamustine. The primary endpoint for the Phase 1b portion was the incidence of dose-limiting toxicities.

In the Phase 2 portion of the study, the safety and efficacy of TRU-016 in combination with bendamustine compared with bendamustine alone in a total of approximately 100 randomized patients will be evaluated. TRU-016 will be dosed over six 28 day cycles.

Pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.