Emergent BioSolutions provides update on TRU-016 Phase 1b study

Emergent BioSolutions Inc. (NYSE: EBS) today announced its decision to expand the protocol for its ongoing Phase 1b, single arm, open label study (Protocol 16009) evaluating the safety and efficacy of TRU-016 in combination with rituximab in previously untreated patients with chronic lymphocytic leukemia (CLL). The expanded protocol will include two new study cohorts to examine a lower dose of TRU-016 with rituximab in front line CLL and to evaluate the combination in relapsed CLL patients. This decision is based on strong patient enrollment along with encouraging early safety and efficacy data from this study. TRU-016 is the company's humanized anti-CD37 monospecific protein therapeutic, built on its ADAPTIR^TM (Modular Protein Technology) platform, for the treatment of CLL.

“We thank our investigators and all of the patients for the progress thus far and look forward to presenting data later this year.”

"Emergent is pleased with the progress of our Phase 1b study of TRU-016 in combination with rituximab in front line patients with CLL. The strong enrollment and the encouraging early data from this open label study are expected to facilitate an expanded clinical trial program that would further support the start of Phase 3 clinical trials for TRU-016 in 2014," said Scott C. Stromatt, M.D., senior vice president and chief medical officer of Emergent BioSolutions. "We thank our investigators and all of the patients for the progress thus far and look forward to presenting data later this year."

The company anticipates that this expanded clinical program will significantly enhance the value of TRU-016 and the company's active partnering program without impacting the company's total 2013 operating expenses.

Update on TRU-016 in Combination with Bendamustine (Protocol 16201)

TRU-016 is also currently being evaluated in a randomized, open label, active-controlled Phase 2 study in combination with bendamustine in patients with relapsed CLL. This study is on track to achieve its target enrollment of approximately 60 patients in April 2013. The primary outcome measurement for this study is overall response rate. Results from the Phase 1b portion of this study, presented at the American Society of Hematology annual meeting on December 8, 2012, indicated that TRU-016 in combination with bendamustine was well tolerated and showed an NCI overall response rate of 83% with a CR rate of 33%Data from the combination study with bendamustine are very encouraging," said Dr. Stromatt. "TRU-016 is a unique molecule with a novel target that has shown additive and/or synergistic efficacy in animal models when used in combination with several therapeutic agents used to treat CLL, such as rituximab, ofatumumab, mTOR inhibitor, bendamustine, and PI3K inhibitors."

Data from both TRU-016 clinical trials are expected to be available in the second half of 2013. TRU-016 has received Orphan Drug status from the FDA and Orphan Medicinal Product Designation from the European Commission for the treatment of CLL.