TRACON
Pharmaceuticals, Inc. (TRACON), a biopharmaceutical company focused on the
development of products for oncology and ophthalmology treatment, and
Micromet, Inc., (Nasdaq: MITI), a biopharmaceutical company focused on the
development of novel, proprietary antibody-based products for cancer,
inflammatory and autoimmune diseases, announced today that TRACON has
started the treatment of the first cancer patient in a Phase 1 clinical
trial with TRC093.
TRC093 is a first-in-class humanized monoclonal antibody that inhibits
angiogenesis and tumor cell growth by binding cleaved collagen, a component
of the extracellular matrix of tumors that serves as the scaffold for new
blood vessel and tumor growth. TRC093 has shown activity, as monotherapy or
when combined with chemotherapy, in pre-clinical studies of melanoma,
breast and pancreatic cancer.
TRC093 is currently being developed by TRACON in oncology and
Age-Related Macular Degeneration (AMD), following execution of a license
agreement with Micromet, Inc. in March 2007, granting TRACON worldwide
rights to develop and commercialize D93 (now TRC093). TRC093 (D93) was
generated and developed by Micromet up to the filing and acceptance of the
IND.
“TRACON’s management team is cohesive and focused on execution. These
qualities, combined with our excellent working relationship with Micromet
and top-notch Phase 1 sites, have allowed us to initiate dosing within four
months of execution of the license agreement,” said Charles Theuer, M.D.,
Ph.D., President and Chief Executive Officer of TRACON Pharmaceuticals,
Inc. “Moving a humanized antibody into the clinic, that has the potential
to treat multiple solid tumors in combination with chemotherapy and
targeted agents, is a major milestone for TRACON in what will be a busy
year for the company. We anticipate dosing two additional first-in-class
cancer treatments later this year.”
The Phase 1 trial is designed to assess the safety, tolerability and
pharmacokinetics, as well as preliminary anti-tumor activity, of TRC093 in
patients with advanced cancer.
“We are very pleased to see that TRACON has initiated a broad
development program very shortly after receiving the license from us in
March of this year. The initiation of the Phase 1 study is an important
milestone for the product and we are looking forward to the expansion of
the program into age- related macular degeneration,” said Jens Hennecke,
Vice President Business Development of Micromet.
About TRACON Pharmaceuticals
TRACON Pharmaceuticals (traconpharma) is a privately held
biopharmaceutical company focused on the development of products for
oncology and ophthalmology treatment, including agents that inhibit
angiogenesis. TRACON addresses unmet needs in these areas with
first-in-class product candidates that will complement existing therapies.
TRC093 is a monoclonal antibody that binds to cleaved collagen to inhibit
angiogenesis and tumor growth. TRC105 is a monoclonal antibody that binds
CD105 to inhibit angiogenesis (IND expected in 2007). TRC102 is a small
molecule that reverses resistance to chemotherapeutics that is currently
being evaluated in a Phase 1 trial and TRC101 is a nanoliposome embedded
with ceramide used to improve the activity and delivery of
chemotherapeutics. TRACON Pharmaceuticals was founded by Paramount
BioSciences, LLC.
About Paramount BioSciences
Paramount BioSciences, LLC is a global drug development and healthcare
investment firm that conceives, nurtures, and supports new biotechnology
and life-sciences companies. For additional information about Paramount
BioSciences, visit paramountbio.
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. Three 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-Hodgkin’s lymphoma. The BiTE product development platform
is based on a unique, antibody-based format that leverages the cytotoxic
potential of T cells, widely recognized as 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, which has
shown activity in patients with high EpCAM expression, 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). Our third clinical stage product candidate is D93,
also known as TRC093, a first-in- class humanized monoclonal antibody that
inhibits angiogenesis and tumor cell growth by binding cleaved collagen, is
being developed by TRACON Pharmaceuticals, Inc. in oncology and Age-Related
Macular Degeneration (AMD) pursuant to a license agreement under which we
have granted TRACON worldwide rights to develop and commercialize
D93/TRC093. In addition, Micromet has established a collaboration with
Nycomed for the development and commercialization of MT203, Micromet’s
human antibody neutralizing the activity of GM-CSF, which may be important
in the treatment of inflammatory diseases, such as rheumatoid arthritis.
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. Such forward-looking statements
include statements regarding the observation of activity of D93/TRC093 in
preclinical studies, and the company’s and TRACON Pharmaceutical Inc.’s
current and planned clinical development activities. 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 collaboration partners 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 collaboration partners, including MedImmune, Merck Serono
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.
Micromet, Inc.
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