Micromet, Inc. (Nasdaq:
MITI), a biopharmaceutical company developing novel, proprietary antibodies
for the treatment of cancer, inflammation and autoimmune diseases,
presented an update of an ongoing phase 1 clinical trial for its BiTE(R)
antibody blinatumomab (MT103/MEDI-538) at the 10th International Conference
on Malignant Lymphomas (ICML) in Lugano, Switzerland. The new data(1) with
the CD19-specific BiTE antibody show that all seven patients in the highest
dose cohort tested so far (0.06 mg/m2/day) achieved complete or partial
responses.
In the study, relapsed, incurable non-Hodgkin's lymphoma (NHL) patients
who previously failed a median of three (and up to 12) conventional
therapies were treated with increasing doses of blinatumomab
(MT103/MEDI-538) for four to eight weeks. Dose-dependent clinical activity
was observed. At the recently completed cohort of 0.06 mg/m2 per day, seven
out of seven patients showed either complete or partial responses.
Remissions in this and the previous dose cohort continue in all patients,
with the longest remission ongoing for more than one year. Most frequent
side effects observed so far were lymphopenia, pyrexia, and leukopenia.
Less common adverse events included transient neutropenia and
thrombocytopenia, transient increase of liver enzymes, and central nervous
system events, all of which were fully reversible.
"The high response rate and apparently durable remissions in this
heavily pre-treated patient population support blinatumomab as a single
agent therapy with the potential for accelerated development," said
Micromet's Senior Vice President and Chief Medical Officer, Dr. Carsten
Reinhardt.
"ICML brings together thousands of the world's leading specialists and
researchers to present the latest advancements and insights in the
treatment of malignant lymphomas," said Dr. Michael J. Keating, University
of Texas MD Anderson Cancer Center professor of medicine, internist for the
department of hematology, ICML advisory board member and a member of
Micromet's BiTE Antibody Scientific Advisory Board. "The data on
blinatumomab show that it holds the promise to become an effective therapy
for a number of lymphomas and leukemias."
(1) Bargou R. et al. (2008). Anti-CD19 BiTE Antibody MT103 (MEDI-538)
Induces Durable Objective Responses in Patients with Relapsed
Non-Hodgkin's Lymphoma (NHL). Update from Ongoing Phase I Study
MT103-104. ICML, Lugano, 2008.
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 advanced BiTE antibody 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. Two additional
BiTE antibodies, targeting CD33 and MCSP, are in preclinical development.
About Micromet, Inc.
Micromet, Inc. (micromet-inc) 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 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 a patient's own cytotoxic T cells, considered the most
powerful "killer cells" of the human immune system, to eliminate cancer
cells. Micromet is developing MT103 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.
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 any forward-looking statements include the risk that product candidates
that 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 to consider statements that include
the words "ongoing," "may," "will," "would," "could," "should," "believes,"
"estimates," "projects," "potential," "expects," "suggests," "plans,"
"anticipates," "intends," "continues," "forecast," "designed," "goal," or
the negative of those words or other comparable words to be uncertain and
forward-looking. These factors and others are more fully discussed in our
periodic reports and other filings with the SEC.
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 otherwise.
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