Emergent BioSolutions Inc. (NYSE: EBS) announced today that three abstracts on its humanized anti-CD37 mono-specific protein therapeutic, TRU-016, and bispecific protein therapeutics have been accepted for presentation at the Annual Meeting of the American Society of Hematology (ASH) on December 8-11, 2012 in Atlanta, Georgia. The data accepted for presentation include results from a Phase 1b study evaluating TRU-016 in combination with bendamustine in patients with relapsed chronic lymphocytic leukemia (CLL). Results from this study concluded that TRU-016 in combination with bendamustine was well tolerated and showed a positive response. “We are very encouraged by the TRU-016 data accepted for presentation at ASH this year,” said Scott C. Stromatt, M.D., Senior Vice President and Chief Medical Officer, Emergent BioSolutions. “We believe that TRU-016’s novel design and synergistic properties could provide a differentiated treatment option in combination with other therapies. We look forward to the results of our ongoing Phase 2 TRU-016 CLL study in combination with bendamustine which we expect in the second half of 2013.” POSTER: Phase 1b Study of TRU-016, an Anti-CD37 SMIP TM Protein, in Combination with Bendamustine vs. Bendamustine Alone in Relapsed Chronic Lymphocytic Leukemia Date: Saturday, December 8, 2012 Presentation Time: 5:30 PM – 7:30 PM Location: Georgia World Congress Center, Hall B1-B2 Patients in the Phase 1b CLL combination study (16201) had 1-3 prior treatments (without prior treatment with bendamustine) and received either 15mg/kg or 20 mg/kg of TRU-016 weekly by intravenous (IV) infusion for two 28-day cycles, then every 14 days for four 28-day cycles. TRU-016 is a novel humanized anti-CD37 SMIP™ (mono-specific protein therapeutic). Bendamustine was administered on days one and two of each cycle by IV infusion for up to six 28-day cycles. Twelve patients were enrolled and treated – six patients at each dose level.
Results reported for Phase 1b CLL study showed the best overall response rate at any time as reported by investigators was 100% with 9 of 12 responses occurring at cycle one. There were four complete responses, two at each dose level. CT scan and bone marrow biopsy results (necessary to determine response by IWCLL criteria) are pending and will be presented at the ASH Annual Meeting. The only grade 3/4 adverse events were neutropenia (six) and febrile neutropenia (three). There were ten serious adverse events reported on four patients. Related serious events were febrile neutropenia (2) and autoimmune hemolytic anemia (pre-existing) and urinary tract infection (1). There was no apparent dose relationship to adverse event frequency.Additional Ongoing TRU-016 CLL Studies A randomized Phase 2 portion of the study (16201) is ongoing evaluating TRU-016 in combination with bendamustine compared to bendamustine alone in relapsed CLL patients. The primary outcome measurement for this study is overall response rate and data is expected in the second half of 2013. In addition, the company recently initiated a Phase 1b, single-arm, open label study (16009) evaluating TRU-016 in combination with rituximab in previously untreated patients. The primary outcome measurement for this study is overall response rate and data is expected at the end of 2013. POSTER: Phase 1b Study of TRU-016, an Anti-CD37 SMIP Protein, in Combination with Rituximab and Bendamustine in Relapsed Indolent Lymphoma Date: Monday, December 10, 2012 Presentation Time: 6:00 PM - 8:00 PM Location: Georgia World Congress Center, Hall B1-B2 Patients in the Phase 1b NHL combination study had relapsed or refractory indolent B-cell non-Hodgkin’s lymphoma (NHL) with a median of three prior regimens. Patients received either 10mg/kg or 20mg/kg of TRU-016 combined with rituximab and bendamustine by IV infusion for up to six 28-day cycles. Twelve patients were enrolled and treated -- nine with follicular lymphoma (FL) and three with small lymphocytic lymphoma.
Results reported for Phase 1b NHL study showed the best overall response rate as reported by investigators was 83% (10 of 12) with four complete responses (32%). Four responding patients (one complete response, three partial responses) discontinued treatment prior to cycle six due to consolidation with transplant (2), development of myelodysplastic syndrome (1), and delayed neutrophil recovery (1). The four discontinuations occurred in the 20mg cohort and limit the response evaluation of the 20mg dose. However, at the time of discontinuation the overall response rate was 67% at 10mg/kg and 100% at 20mg/kg. Three of the four patients with bulky disease responded to the regimen.Grade 3/4 adverse events that occurred were neutropenia (6), hypophosphatemia (3), and white blood count decrease (2). Serious adverse events included asymptomatic pulmonary thrombosis (2) and febrile neutropenia (1), pneumonia (1), myelodysplastic syndrome (1), deep vein thrombosis (1), and retinal vein occlusion (1). There was no apparent dose relationship to adverse event frequency. POSTER: Bispecific SCORPION™ Molecules Effectively Redirect T Cell Cytotoxicity Toward CD19-Expressing Tumor Cells Date: Monday, December 10, 2012 Presentation Time: 6:00 PM - 8:00 PM Location: Georgia World Congress Center, Hall B1-B2 Despite advances in treatments for B cell leukemias and lymphomas, many patients ultimately relapse and succumb to disease following multiple courses of therapy. Bispecific antibody fragments that can simultaneously engage T cells and tumor cells have been shown to destroy tumor cells by effectively redirecting the cytotoxic function of T cells. T cell engaging bispecific molecules linking anti-CD19 and anti-CD3 binding domains in the context of novel SCORPION ™ (multi-specific protein therapeutic) proteins were evaluated both in vitro and in vivo for function and stability. Results reported for the preclinical study indicated that SCORPION molecules targeting CD19 and CD3 effectively harness the cytotoxic activity of T cells to kill CD19 positive tumor cells both in vitro and in vivo and show potential for further investigation as possible therapeutic agents for B cell malignancies. About Emergent BioSolutions Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information about us may be found at www.emergentbiosolutions.com. Follow us on twitter: @emergentbiosolu. Safe Harbor Statement This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, prospects, plans and objectives of management, and any other statements containing the words “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.
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