Micromet, Inc. (Nasdaq: MITI) and MedImmune, Inc. (Nasdaq: MEDI) today
announced data from a preclinical study in which BiTE(R) molecules
targeting carcinoembryonal antigen (CEA) were shown to prevent subcutaneous
tumor growth and formation of lung metastases. An established marker for
tumor progression, CEA is frequently expressed on breast, colon and other
human carcinomas. These data, presented yesterday in a poster session at
the 2007 Annual Meeting of the American Association for Cancer Research
(AACR), augment a growing body of preclinical and clinical research about
the potential anti-cancer activity of BiTE molecules.
BiTE molecules represent a novel class of drugs that function as bi-
specific T-cell engagers. They are unique in their ability to enable the
body's killer T cells to recognize and attack tumor and target cells,
leaving normal cells unharmed. In addition to demonstrating in vitro and in
vivo anti- tumor activity, certain CEA-specific BiTE molecules also showed
resistance to inhibition by soluble CEA. Because a soluble form of CEA is
released from the surface of normal and tumor cells into the bloodstream,
BiTE molecules targeting the antigen must not be inhibited by soluble CEA.
"In a joint effort, researchers at Micromet and MedImmune have
developed CEA BiTE molecules that appear to be highly potent and to ignore
levels of soluble CEA present in cancer patients while continuing to
destroy tumor cells," said Patrick Baeuerle, Ph.D., Chief Scientific
Officer at Micromet.
CEA is the second target in the research collaboration between Micromet
and MedImmune against which new BiTE molecules were successfully generated
and tested. The first target is the tyrosine kinase receptor EphA2, which
is frequently overexpressed on a wide variety of solid tumors. Research
published April 15, 2007 in Cancer Research demonstrated that the BiTE
molecule targeting EphA2 killed tumor cells at dose levels considerably
below those required by classical monoclonal antibody-based therapies in in
vivo and in vitro proof-of-concept studies.
"The EphA2 and CEA antigens are the focus of ongoing preclinical
research within MedImmune's broad pipeline of potential treatments for
cancer," said Peter Kiener, MedImmune's Senior Vice President, Research.
"Both have been implicated in the growth and survival of a range of tumor
types, and we are encouraged by the preclinical study results to date with
these two highly potent BiTE molecules."
About BiTE(R) Molecules
BiTE molecules are a novel class of antibody derivatives with the
potential to selectively direct and activate an individual's cytotoxic T
cells, the body's most potent killer cells, to act against cancer cells.
MT103/MEDI-538, a BiTE molecule targeting the B cell antigen CD19, provided
clinical proof-of-concept for the BiTE platform technology, as presented at
the last meeting of the American Society for Hematology. In an ongoing
phase 1 study, MT103/MEDI-538 has shown potent elimination of tumor target
cells in peripheral blood, bone marrow, lymph nodes and spleen of
therapy-refractory non-Hodgkins lymphoma patients.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical
options for physicians, rewarding careers to employees, and increased value
to shareholders. Dedicated to advancing science and medicine to help people
live better lives, the company is focused on the areas of infectious
disease, cancer and inflammatory diseases. With more than 2,500 employees
worldwide, MedImmune is headquartered in Maryland. For more information,
visit the company's website at medimmune.
About Micromet, Inc.
Micromet, Inc. is a biopharmaceutical company focusing on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases. Two product candidates are currently
in clinical trials. MT103/MEDI-538, which is the first product candidate
based on Micromet's novel BiTE(R) product development platform, is being
evaluated in a phase 1 clinical trial for the treatment of patients with
non-Hodgkins lymphoma. The BiTE product development platform is based on a
unique, antibody-based format that leverages the cytotoxic potential of T
cells, the most powerful 'killer cells' of the human immune system.
Adecatumumab (MT201), a recombinant human monoclonal antibody which targets
EpCAM expressing tumors, has completed two phase 2a clinical trials, one in
patients with breast cancer and the other in patients with prostate cancer.
In addition, a phase 1b trial evaluating the safety and tolerability of
MT201 in combination with docetaxel is currently ongoing in patients with
metastatic breast cancer. Micromet has established collaborations with
MedImmune, Inc. for MT103/MEDI-538 and Merck Serono for adecatumumab
(MT201).
Forward-Looking Statements of MedImmune, Inc.
This announcement contains, in addition to historical information,
certain "forward-looking statements" regarding the development of a novel
BiTE(R) molecule (bscEphA2xCD3) targeting the tyrosine kinase receptor
EphA2 and CEA- BiTE targeting the CEA antigen to treat certain cancers.
Such forward-looking statements are based on current expectations and
involve inherent risks and uncertainties, including factors that could
delay, divert or change and could cause actual outcomes and results to
differ materially from current expectations. In addition to risks and
uncertainties discussed in MedImmune's filings with the U.S. Securities and
Exchange Commission, no assurance exists that development efforts for any
such product will succeed, that any such product will receive required
regulatory approval or that, even if regulatory approval is received, any
such product will be commercially successful. MedImmune undertakes no
obligation to update any forward-looking statement, whether as a result of
new information, future events or otherwise except as may be required by
applicable law or regulation.
Forward-Looking Statements of Micromet, Inc.
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. Such forward-looking statements
include statements regarding the intended utilization of product
candidates, the conduct and results of future clinical trials, plans
regarding regulatory filings, future research, discovery of new product
candidates, and clinical trials, and partnering activities. Factors that
may cause actual results to differ materially include the risk that product
candidates that appeared promising in early research and clinical trials do
not demonstrate safety and/or efficacy in larger-scale or later clinical
trials, the risks associated with regulatory processes, the risks
associated with reliance on outside financing to meet capital requirements,
and the risks associated with reliance on collaborative partners for future
revenues under the terms of its existing collaboration agreements, and for
further pre-clinical and clinical studies, development and
commercialization of product candidates. You are urged to consider
statements that include the words "appear," "may," "will," "would,"
"could," "should," "believes," "estimates," "projects," "potential,"
"expects," "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 Micromet's periodic reports and other filings with
the SEC, including the "Risk Factors" sections of such reports.
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 and MedImmune undertake no obligation to publicly update any
forward- looking statements, whether as a result of new information, future
events or otherwise.
Micromet, Inc.
micromet-inc
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