BETHESDA and GAITHERSBURG, Md., June 12 /PRNewswire-FirstCall/ --
Micromet, Inc. (Nasdaq: MITI) and MedImmune announced today that the first
patient has started treatment in a multi-center, phase 2 trial conducted in
Germany investigating BiTE(R) antibody blinatumomab (MT103/MEDI-538) in
patients with adult acute lymphoblastic leukemia (ALL). Blinatumomab is a T
cell engaging antibody targeting the CD19 antigen, which is only expressed on
B cells. The clinical development program for blinatumomab was expanded to
include ALL as an additional indication after data from an ongoing phase 1
clinical trial showed potent single-agent activity of the BiTE antibody in
patients with late-stage non-Hodgkin's lymphoma (NHL). These data were
presented last December at the 2007 Annual Meeting of the American Society of
Hematology (ASH), and an update of this trial was presented last week at the
10th International Conference on Malignant Lymphomas (ICML) in Lugano,
Switzerland.
"This phase 2 clinical trial in ALL is an important step to assess
activity of blinatumomab in aggressive forms of B cell malignancies and will
help to determine the full therapeutic potential of this highly specific and
potent BiTE antibody in human B cell cancers," said Carsten Reinhardt, M.D.,
senior vice president and chief medical officer of Micromet.
ALL is a very aggressive form of B cell leukemia. Patients with ALL are
initially treated with complex and highly toxic chemotherapy regimens, which
may be followed by bone marrow stem cell transplantation for eligible
patients. Patients who have a low number of residual tumor cells in their bone
marrow after chemotherapy (also known as "minimal residual disease" or MRD)
are at a very high risk of early relapse. This phase 2 clinical trial recruits
patients with MRD and will test whether blinatumomab can eliminate residual
tumor cells and prolong the time to relapse. A systematic process has been
established for the MRD screening of all ALL patients which are referred to
the German ALL study group (GMALL). The patients identified in this screening
as MRD-positive are now referred to the clinical trial.
"Improved treatments and reduction of relapse rate in patients with
MRD-positive ALL represent a high medical need. Although CD19 is widely
expressed in ALL, no therapies targeting CD19 are currently available," said
Professor D. Hoelzer, chairman of the German ALL study group (GMALL).
About BiTE Antibodies
BiTE(R) antibodies are designed to direct the body's cytotoxic, or
cell-destroying, T cells against tumor cells, and represent a new therapeutic
approach to cancer therapy. BiTE antibodies have been shown to induce an
immunological synapse between a T cell and a tumor cell in the same manner as
observed during physiological T cell attacks. These cytolytic synapses enable
the delivery of cytotoxic proteins from T cells into tumor cells, ultimately
inducing a self-destruction process in the tumor cell referred to as
apoptosis, or programmed cell death. In the presence of BiTE antibodies, T
cells have been demonstrated to serially eliminate tumor cells, which explains
the activity of BiTE antibodies at very low concentrations and at very low
ratios of T cells to target cells. Through the process of killing cancer
cells, T cells proliferate, which leads to an increased number of T cells at
the site of attack.
Several antibodies in Micromet's product pipeline are BiTE antibodies and
have been generated based on Micromet's proprietary BiTE antibody platform.
The most clinically advanced BiTE antibody program is MT103 (MEDI-538),
targeting CD19, and has provided proof-of-concept in an ongoing phase 1
clinical study in patients with advanced non-Hodgkin's lymphoma. MT110, which
is targeting EpCAM (CD326) and is the first BiTE antibody with potential
applications in the treatment of solid tumors, is in a phase 1 clinical trial
in patients with lung or gastrointestinal cancers. Three additional BiTE
antibodies, targeting CD33, CEA and MCSP, are in preclinical development.
About Blinatumomab
Blinatumomab, also known as MT103 or MEDI-538, is a BiTE(R) antibody being
developed with the intent to treat certain types of B cell lymphomas. In
February 2006, the U.S. Food and Drug Administration approved an orphan drug
designation for blinatumomab for certain types of indolent B cell lymphoma.
Blinatumomab also received orphan drug designation from the European Medicines
Agency for mantle cell lymphoma and chronic lymphocytic leukemia. Blinatumomab
specifically targets the CD19 antigen, which is present on B cells and B
cell-derived tumors, but not on other types of blood cells or healthy tissues.
Micromet and MedImmune are developing blinatumomab under the terms of a
2003 agreement in which MedImmune has obtained exclusive rights for
blinatumomab in North America. Micromet has retained the rights to
blinatumomab outside of North America.
About Micromet, Inc.
Micromet, Inc. (www.micromet-inc.com) is a biopharmaceutical company
developing novel, proprietary antibodies for the treatment of cancer,
inflammation and autoimmune diseases. Four of its antibodies are currently in
clinical trials, while the remainder of the product pipeline is in preclinical
development. The BiTE(R) antibody blinatumomab, also known as MT103, is in a
phase 2 clinical trial for the treatment of patients with acute lymphoblastic
leukemia and in a phase 1 clinical trial for the treatment of patients with
non-Hodgkin's lymphoma. BiTE antibodies represent a new class of antibodies
that activate the T cells of a patient's own immune system to eliminate cancer
cells. Micromet is developing blinatumomab in collaboration with MedImmune,
Inc., a subsidiary of AstraZeneca plc. MT110 is the second BiTE antibody in
clinical trials, and is being developed by Micromet in a phase 1 clinical
trial for the treatment of patients with lung or gastrointestinal cancer. The
third clinical stage antibody is adecatumumab, also known as MT201, a human
monoclonal antibody which targets epithelial cell adhesion molecule
(EpCAM)-expressing solid tumors. Micromet is developing adecatumumab in
collaboration with Merck Serono in a phase 1b clinical trial evaluating
adecatumumab in combination with docetaxel for the treatment of patients with
metastatic breast cancer. The fourth clinical stage antibody is MT293 which is
licensed to TRACON Pharmaceuticals, Inc. and is being developed in a phase 1
clinical trial for the treatment of patients with cancer. Three additional
BiTE antibodies, targeting CD33, CEA and MCSP, are in preclinical development.
In addition, Micromet has established a collaboration with Nycomed for the
development and commercialization of MT203, a human antibody neutralizing the
activity of granulocyte/macrophage colony stimulating factor (GM-CSF), which
has potential applications in the treatment of various inflammatory and
autoimmune diseases, such as rheumatoid arthritis, psoriasis, or multiple
sclerosis.
About MedImmune
MedImmune is wholly owned by AstraZeneca plc (LSE: AZN.L, NYSE: AZN) and
is the worldwide biologics business for the AstraZeneca Group. The company
has approximately 3,000 employees worldwide and is headquartered in
Gaithersburg, Maryland. MedImmune strives to provide better medicines to
patients, new medical options for physicians and rewarding careers to
employees. Dedicated to advancing science and medicine to help people live
better lives, the company is focused on infection, oncology, respiratory
disease and inflammation, cardiovascular/gastrointestinal disease and
neuroscience. For more information, visit MedImmune's website at
www.medimmune.com.
Forward-Looking Statements
This release contains certain forward-looking statements that involve
risks and uncertainties that could cause actual results to be materially
different from historical results or from any future results expressed or
implied by such forward-looking statements. Factors that may cause actual
results to differ materially from any future results expressed or implied by
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appeared promising in early research, preclinical studies or clinical trials
do not demonstrate safety and/or efficacy in subsequent clinical trials, the
risk that encouraging results from early research, preclinical studies or
clinical trials may not be confirmed upon further analysis of the detailed
results of such research, preclinical study or clinical trial, the risk that
additional information relating to the safety, efficacy or tolerability of our
product candidates may be discovered upon further analysis of preclinical or
clinical trial data, the risk that we or our collaborators will not obtain
approval to market our product candidates, the risks associated with reliance
on outside financing to meet capital requirements, and the risks associated
with reliance on collaborators, including MedImmune, Merck Serono, TRACON and
Nycomed, for the funding or conduct of further development and
commercialization activities relating to our product candidates. You are urged
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Any forward-looking statements are made pursuant to Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the Securities Exchange
Act of 1934, as amended, and, as such, speak only as of the date made.
Micromet, Inc. undertakes no obligation to publicly update any forward-looking
statements, whether as a result of new information, future events or
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SOURCE Micromet, Inc.
CONTACT:
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