Monday March 7, 2005
Panacea Pharmaceuticals, Inc. and Massachusetts Institute of Technology
Achieve Major Milestone in HAAH Oncology Therapeutic Collaboration
Company Exercises Worldwide, Exclusive License Option Covering Developments
March 7, 2005 - Gaithersburg, Maryland - Panacea Pharmaceuticals,
Inc. (the Company) announced today the achievement of major developmental
milestones in the production of engineered fully-human antibodies
for its HAAH Oncology Program under a collaboration with the
Massachusetts Institute of Technology (MIT), as well as the exercising
of a license option with MIT that provides Panacea exclusive,
worldwide commercialization rights covering these developments.
The milestones pertain to the development of an engineered,
all-human, single-chain antibody fragment against HAAH via a
proprietary yeast display technology. Identified fragments were
then back-engineered into full-sized and fully human IgG antibodies
that demonstrated affinities at least ten times higher than previously
identified murine monoclonal antibodies. Testing of these new
molecules revealed that they bind specifically to cancer cells
as determined by FACS analysis and immunohistochemistry, as well
as stain cancer tissue but not normal adjacent tissue. Significantly,
strong evidence supports that these new molecules upon binding
to HAAH on the cellular surface internalize into the cancer cell.
Further functional and biochemical analyses are being performed
by the Company.
"The newly delivered antibodies represent a novel breakthrough
and a major developmental achievement against a compelling cancer
target," stated K. Dane Wittrup, PhD, the Joseph R. Mares
Professor of Chemical Engineering & Bioengineering at MIT
and Principal Investigator under the collaboration. "We
look forward to continuing our collaboration with Panacea in
the exploration of these antibodies as potentially potent anticancer
molecules."
"The availability of fully-human antibodies directed-against
HAAH has propelled our therapeutic program forward toward clinical
development," stated Hossein A. Ghanbari, PhD, CEO and Chief
Scientific Officer of the Company. "We're further excited
by the outstanding characteristics of these molecules, such as
increased affinity, which has the potential to yield even stronger
efficacies in vivo than we have seen with their murine counterparts."
The Company has funded research at MIT since February 2001.
Under the agreement, Panacea retained an option for exclusive
worldwide commercialization rights to antibodies resulting from
the collaboration, which it has now exercised. The relevant intellectual
property is fully protected under a clearly defined patent application.
Background on Yeast Display Technology
The technology uses a yeast surface display method for engineering
antibody fragments of extremely high affinity. The technology
was first described in the September 2000 issue of Proceedings
of the National Academy of Sciences (vol. 97, no. 20, pp. 10701-10705)
entitled, "Directed evolution of antibody fragments with
monovalent femtomolar antigen-binding affinity." This paper
reported the development of single-chain antibody mutants that
possess the highest monovalent ligand-binding affinity yet reported
for an engineered protein by over two orders of magnitude.
Background on HAAH Oncology Program
The Company's HAAH Oncology Program is based on the enzyme human
aspartyl (asparaginyl) Beta-hydroxylase (HAAH). HAAH over-expression
has been detected in primary tumor tissue of more than twenty
tumor types tested to date, including cancers of the pancreas,
breast, ovary, liver, colon, prostate, lung, brain, and bile
duct. HAAH over-expression has been detected in 99% of tumor
specimens (greater than 1000) tested to date and has not been
detected in normal or adjacent non-affected tissue.
Preclinical studies have indicated that over-expression of HAAH
is sufficient to induce cellular transformation, to increase
cell motility and invasiveness, and to establish tumor formation
in animals. HAAH is over-expressed on the surface of cancer cells
facilitating an antibody-based treatment approach. In in vitro
studies, anti-HAAH antibodies have been shown to have a beneficial
effect on tumor cells, causing them to revert to a more normal
phenotype as measured by the inhibition of growth, motility,
and invasiveness. Recent studies have investigated the efficacy
of anti-HAAH antibodies in vivo and have indicated that the murine
forms of these antibodies are capable of inhibiting tumor formation
and growth in a xenograft model of primary human liver cancer.
Furthermore these antibodies significantly reduced the number
and size of metastases in a model of human colon cancer metastasis
to the liver.
The Company is actively pursuing the development of anti-HAAH
antibodies as novel agents for the treatment of cancer, with
liver cancer as its first intended indication. The Company is
exploring the utility of naked anti-HAAH antibodies, as well
as antibody conjugates with various chemotherapeutic agents as
lead candidates in this regard. In addition, the Company maintains
an active diagnostic development program also based on anti-HAAH
antibodies. The confluence of these two programs presents a fully
integrated approach to cancer treatment and management.
About Panacea Pharmaceuticals, Inc.
Panacea Pharmaceuticals, Inc. is an emerging biopharmaceutical
company focused on using functional genomics and proteomics to
develop therapeutics and diagnostics for diseases with substantial
unmet clinical need. The Company's product development focus
is on novel proteins and biochemical pathways related to cellular
regulation and cell cycle abnormalities in oncology as well as
both acute and chronic neurodegenerative conditions such as hypoxia-induced
cognitive impairment, Parkinson's disease, and Alzheimer's disease.
More information about the Company is available at http://www.PanaceaPharma.com.
Except for historical information presented in this press release,
matters discussed herein may constitute "forward-looking
statements" within the meaning of the Private Securities
Litigation Reform Act of 1995. Forward-looking statements are
based on the opinions and estimates of management only as of
the date of this release and are subject to certain risks and
uncertainties that could cause actual results to differ materially
from any future results, performance, or achievements expressed
or implied by such statements. Factors that might cause such
a difference include, but are not limited to, uncertainties related
to our access to capital, the progress, costs, and results of
any clinical trials undertaken by us, progress of our research
and development projects, and uncertainties related to whether
our product candidates would ultimately achieve commercial success.
We do not undertake any obligation to update publicly any forward-looking
statement, whether as a result of new information, future events,
or otherwise unless required by law.
Contact:
Panacea Pharmaceuticals, Inc.
Kasra Ghanbari
Phone 240-243-8000 x108; FAX 240-465-0450
Kasra@PanaceaPharma.com
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