Emergent BioSolutions Announces Acceptance of TRU-016 and Bispecific Abstracts for Presentation at 2012 American Society of Hematology Annual Meeting
“We are very encouraged by the TRU-016 data accepted for presentation at
ASH this year,” said
POSTER: Phase 1b Study of TRU-016, an Anti-CD37 SMIPTM
Protein, in Combination with Bendamustine vs. Bendamustine Alone in
Relapsed Chronic Lymphocytic Leukemia
Date:
Presentation Time:
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:
Presentation Time:
Location: Georgia World Congress Center, Hall
B1-B2
Patients in the Phase 1b
Results reported for Phase 1b
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:
Presentation Time:
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
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.
There are a number of important factors that could cause the company’s
actual results to differ materially from those indicated by such
forward-looking statements, including the success of our ongoing and
planned preclinical studies and clinical trials; the rate and degree of
market acceptance and clinical utility of our products; the success of
our ongoing and planned development programs; the timing of and our
ability to obtain and maintain regulatory approvals for our product
candidates; our commercialization, marketing and manufacturing
capabilities and strategy; and our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing. The
foregoing sets forth many, but not all, of the factors that could cause
actual results to differ from our expectations in any forward-looking
statement. Investors should consider this cautionary statement, as well
as the risk factors identified in our periodic reports filed with the
Source:
Emergent BioSolutions
Investor Contact:
Robert G.
Burrows
Vice President, Investor Relations
301-795-1877
BurrowsR@ebsi.com
or
Media
Contact:
Tracey Schmitt
Vice President, Corporate
Communications
301-795-1800
SchmittT@ebsi.com