Micromet Presents Update at ASCO 2009 on a Phase 1b Combination Study of Adecatumumab...

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Mon Jun 1, 2009 7:01am EDT

Micromet Presents Update at ASCO 2009 on a Phase 1b Combination Study of
Adecatumumab and Docetaxel

Data indicate target-dependent activity in breast cancer patients with high
expression of EpCAM

ORLANDO, Fla., June 1 /PRNewswire-FirstCall/ -- Micromet, Inc. (Nasdaq: MITI),
a biopharmaceutical company developing novel, proprietary antibodies for the
treatment of cancer, inflammation and autoimmune diseases, presented data from
a clinical trial investigating its anti-EpCAM human antibody adecatumumab
(MT201) in combination with the chemotherapeutic docetaxel in patients with
metastatic breast cancer (MBC) at the annual meeting of the American Society
of Clinical Oncology (ASCO) held in Orlando, Florida, USA(1).

The phase 1b clinical trial presented at ASCO investigates the safety and
tolerability of increasing doses of adecatumumab given every 3 weeks in
combination with standard chemotherapy docetaxel (Taxotere(R)) in relapsed MBC
patients who had a median of three prior chemotherapy regimens (n=22
assessable for safety and n=19 evaluable for efficacy). Adecatumumab is an
antibody that targets EpCAM, a tumor antigen known to be associated with poor
prognosis for breast cancer patients. Combining adecatumumab with docetaxel
was feasible with clinically manageable diarrhea being the main toxicity at
higher doses. Other frequently observed adverse events included nausea,
vomiting, stomatitis, constipation, fatigue, fever and chills. Laboratory
abnormalities included reduction in various blood cells such as lymphocytes
and neutrophils comparable to what is typically observed with docetaxel
monotherapy. 

The overall response rate according to RECIST [version 1.0] was 38% in
patients with high expression of EpCAM (n=8), the target of adecatumumab,
compared to 9% in patients with low EpCAM expression (n=11). Patients treated
with higher doses of adecatumumab also appeared to have a longer time to
progression when compared to patients treated at lower doses (167 days versus
83 days). These observations are in line with data from a previous phase 2
trial investigating adecatumumab as a single agent in MBC patients that also
suggested that treatment with adecatumumab was associated with better outcome
in patients with high EpCAM expression compared to patients with low EpCAM
expression(2). Micromet is currently also conducting a randomized phase 2
clinical trial with adecatumumab in patients with colorectal cancer after
complete resection of liver metastases.

"These data indicate that adding adecatumumab to standard chemotherapy is
feasible," said Carsten Reinhardt, M.D., Ph.D., senior vice president and
chief medical officer of Micromet. "The combination of adecatumumab with
taxanes could be a valuable development option for MBC patients with high
EpCAM expression on their tumors, and would offer an antibody-based therapy to
those patients who express EpCAM but not Her-2 and thus do not qualify for
Her-2-targeting antibody therapy."

(1) Sebastian, M. et al. (2009). Safety and anti-tumor activity of 3-weekly
anti-EpCAM antibody adecatumumab (MT201) in combination with docetaxel for
patients with metastatic breast cancer: Results of a multicenter phase Ib
trial. ASCO meeting abstract no. 1009. 

(2) Schmidt, M. et al. (2009). An open-label, randomized phase II study of
adecatumumab, a fully human anti-EpCAM antibody, as monotherapy in patients
with metastatic breast cancer. Annals of Oncology, in press.

About Micromet, Inc.

Micromet, Inc. is a biopharmaceutical company developing novel, proprietary
antibodies for the treatment of cancer, inflammation and autoimmune diseases.
Its product development pipeline includes novel antibodies generated with its
proprietary BiTE(R) antibody platform, as well as conventional monoclonal
antibodies. BiTE antibodies represent a new class of antibodies that activate
the T cells of a patient's immune system to eliminate cancer cells. Four of
Micromet's antibodies are currently in clinical trials. Its BiTE antibody
blinatumomab (MT103) is in a phase 2 clinical trial for the treatment of
patients with acute lymphoblastic leukemia (ALL), and in a phase 1 clinical
trial for the treatment of patients with non-Hodgkin's lymphoma (NHL). A
second BiTE antibody, MT110, is in a phase 1 clinical trial for the treatment
of patients with solid tumors. MT110 binds to the epithelial cell adhesion
molecule, or EpCAM, which is overexpressed in many solid tumors. Micromet's
human monoclonal antibody adecatumumab (MT201) also binds to EpCAM and is
being developed under a collaboration with Merck Serono, a division of Merck
KGaA of Darmstadt, Germany. Adecatumumab is in a phase 2 clinical trial in
colorectal carcinoma patients after complete resection of liver metastases,
and a phase 1b clinical trial evaluating adecatumumab in combination with
docetaxel for the treatment of patients with metastatic breast cancer.
Micromet's monoclonal antibody MT293, also known as TRC093, is licensed to
TRACON Pharmaceuticals, Inc., and is in a phase 1 clinical trial for the
treatment of patients with cancer.

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. Nycomed has filed a clinical trial application and is expected to
commence a phase 1 clinical trial of MT203 in the first half of 2009.
Micromet's licensee Morphotek, a wholly-owned subsidiary of Eisai, is also
expected to initiate a first phase 1 clinical trial with Micromet's
glycolipid-binding human antibody MT228 for the treatment of melanoma.
Micromet also has entered into an option, collaboration and license agreement
with Bayer Schering Pharma AG under which Bayer Schering Pharma was granted an
exclusive option to license a specified BiTE antibody against an undisclosed
solid tumor target.
Micromet's preclinical product pipeline includes several novel BiTE antibodies
generated with its proprietary BiTE antibody platform technology. BiTE
antibodies targeting CEA, MSCP, CD33, HER2, EGFR and other targets are in
various stages of preclinical development.

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. These forward-looking statements include
statements regarding the efficacy, safety and intended utilization of
adecatumumab and other product candidates, the conduct, timing and results of
future clinical trials, and expectations of the future expansion of our
product pipeline and collaborations. You are urged to consider statements that
include the words "ongoing," "may," "will," "believes," "potential,"
"expects," "plans," "anticipates," "intends," or the negative of those words
or other similar words to be uncertain and forward-looking. 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. These factors and others are more fully discussed in
Micromet's Quarterly Report on Form 10-Q for the fiscal quarter ended March
31, 2009, filed with the SEC on May 11, 2009, as well as other filings by the
company with the SEC.

SOURCE  Micromet, Inc.

US Media: Andrea tenBroek or Chris Stamm, +1-781-684-0770,
micromet@schwartz-pr.com; or for European Media: Ludger Wess,
+49-(40)-8816-5964, ludger@akampion.com; or for US Investors: Susan Noonan,
+1-212-966-3650, susan@sanoonan.com; or for European Investors: Ines-Regina
Buth, +49-(30)-2363-2768, ines@akampion.com, all for Micromet, Inc.
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