Expanded Range of HER1, HER2 and HER3 Assays to Provide Unique Insights and
Facilitate Development of Personalized Cancer Therapies
SOUTH SAN FRANCISCO, May 1 /PRNewswire-FirstCall/ -- Monogram
Biosciences, Inc. (Nasdaq: MGRM) today announced that the company's HER1
and HER3 Quantitative Protein Assays are now available for clinical
development use. Built on Monogram's VeraTag(TM) platform, the HER1 and
HER3 assays provide unique, quantitative measurements of protein expression
and activity in formalin fixed paraffin embedded (FFPE) tumor samples.
These assays supplement HERmark(TM), Monogram's HER2 and HER2:HER2
Homodimer Breast Cancer Assay, and expands the potential clinical reach of
Monogram's VeraTag assays to lung, colorectal and other cancers.
"We are excited to make the HER1 and HER3 assays available for clinical
development use," said William Young, president and CEO of Monogram
Biosciences. "Our first VeraTag product, HERmark, is already available for
use in clinical development programs through our CLIA-approved laboratory
and provides quantitative and accurate measurements of the expression of
HER2 and HER2:HER2 homodimers. The addition of the HER1 and HER3 assays
expands the reach of our VeraTag technology and we look forward to forging
collaborations with biopharmaceutical companies to advance the use of our
diagnostics and enable the development of new treatment options for those
living with cancer."
"Oncologists have long known about the role that HER2 plays in breast
cancer and, although far from perfect, have had some tools available to
measure it," said Michael Bates, M.D., Monogram vice president of clinical
research. "Accurate, quantitative measurements for EGFR (HER1) and HER3
have never before been available and are badly needed to help unravel the
complex biology of cancer and enable the development and clinical use of
targeted cancer therapies."
"Our HER1 and HER3 assays provide accurate, precise and highly
reproducible measurements of these key analytes with sensitivity more than
five times that of routinely performed IHC testing," said Gordon Parry,
Ph.D., Monogram vice president of research & development, oncology. "Making
these measurements in FFPE tissue is particularly important as this is the
standard fixation and storage method in most pathology laboratories."
Monogram has a growing portfolio of VeraTag assays that measure
proteins, protein complexes and post-translational modifications such as
phosphorylation, in FFPE tumor samples and can aide cancer drug development
and clinical evaluation. The HERmark Assay is validated according to
CAP/CLIA regulations for routine testing in our CLIA-approved clinical
reference laboratory and provides measurements of HER2 and HER2:HER2
homodimers. In addition to the HER1 and HER3 assays that are now available
for clinical development use, Monogram has assays in advanced development
for the measurement of heterodimers of HER1 and HER2 (HER1:HER2), for the
measurement of heterodimers of HER2 and HER3 (HER2:HER3), and for the
measurement of a truncated form of HER2, known as p95. These activated
proteins are believed to mediate resistance to Herceptin(R) in patients
with breast cancer and are targets of other cancer drugs in development.
This extended range of assays will expand the clinical reach of Monogram's
assays to lung, colorectal and other cancers. Understanding these protein
markers is expected to inform the rational design of combination therapies,
such as those for patients with resistance to Herceptin.
About HERmark
HERmark is a proprietary diagnostic that accurately quantifies HER2
expression and HER2:HER2 dimerization in patients with breast cancer.
Preliminary data from three cohorts of Herceptin-treated patients with
metastatic breast cancer who were identified as "HER2 positive" by
conventional assays suggest that HERmark can identify patients who are
likely to respond to Herceptin with greater precision than currently
available tests, permitting stratification of patients according to their
degree of clinical benefit from the drug. Additional studies of HERmark for
breast cancer in both the metastatic and adjuvant settings are in progress.
About VeraTag
VeraTag is a proximity-based assay technology platform that accurately
quantifies proteins and functional protein complexes. This platform
provides a researcher or clinician a more thorough understanding of
protein-protein interactions or signaling pathway activity allowing for
disease characterization at the molecular level. VeraTag is designed to run
on standard formalin-fixed paraffin embedded (FFPE) patient samples.
About Monogram
Monogram is advancing individualized medicine by discovering,
developing and marketing innovative products to guide and improve treatment
of serious infectious diseases and cancer. The Company's products are
designed to help doctors optimize treatment regimens for their patients
that lead to better outcomes and reduced costs. The Company's technology is
also being used by numerous biopharmaceutical companies to develop new and
improved anti-viral therapeutics and vaccines as well as targeted cancer
therapeutics. More information about the Company and its technology can be
found on its web site at http://www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking. These
forward-looking statements include references to, the ability of VeraTag
technology to significantly improve the information available to
physicians, results of studies intended to demonstrate clinical utility of
our VeraTag technology and products and anticipated clinical and laboratory
validation of VeraTag in a CLIA setting, future commercialization of the
HERmark assay based on the VeraTag technology, expected protection provided
by patents, and possible regulation of our products by the FDA. These
forward-looking statements are subject to risks and uncertainties and other
factors, which may cause actual results to differ materially from the
anticipated results or other expectations expressed in such forward-looking
statements. These risks and uncertainties include, but are not limited to:
risks and uncertainties relating to the performance of our products; the
growth in revenues; the risk that our VeraTag assays may not predict
response to particular therapeutic agents; the risk that we may not be able
to obtain additional cohorts of patient samples for additional VeraTag
studies, our ability to successfully conduct clinical studies and the
results obtained from those studies; whether larger confirmatory clinical
studies will confirm the results of initial studies; our ability to
establish reliable, high-volume operations at commercially reasonable
costs; actual market acceptance of our products and adoption of our
technological approach and products by pharmaceutical and biotechnology
companies; our estimate of the size of our markets; our estimates of the
levels of demand for our products; the impact of competition; the timing
and ultimate size of pharmaceutical company clinical trials; whether payers
will authorize reimbursement for our products and services and the amount
of such reimbursement that may be allowed; whether the FDA or any other
agency will decide to further regulate our products or services; whether
the draft guidance on Multivariate Index Assays issued by FDA will be
subsequently determined to apply to our current or planned products;
whether we will encounter problems or delays in automating our processes;
the ultimate validity and enforceability of our patent applications and
patents; the possible infringement of the intellectual property of others;
whether licenses to third party technology will be available; whether we
are able to build brand loyalty and expand revenues; restrictions on the
conduct of our business imposed by the Pfizer, Merrill Lynch and other debt
agreements; the impact of additional dilution if our convertible debt is
converted to equity; and whether we will be able to raise sufficient
capital in the future, if required. For a discussion of other factors that
may cause actual events to differ from those projected, please refer to our
most recent annual report on Form 10-K and quarterly reports on Form 10-Q,
as well as other subsequent filings with the Securities and Exchange
Commission. We do not undertake, and specifically disclaim any obligation,
to revise any forward-looking statements to reflect the occurrence of
anticipated or unanticipated events or circumstances after the date of such
statements.
VeraTag and HERmark are trademarks of Monogram Biosciences, Inc.
Herceptin is a registered trademark of Genentech, Inc.
contacts: Alfred G. Merriweather Jeremiah Hall
Chief Financial Officer Feinstein Kean Healthcare
Tel: 650 624-4576 Tel: 415 677-2700
amerriweather@ jeremiah.hall@
monogrambio.com fkhealth.com
SOURCE Monogram Biosciences, Inc.
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Related links:
http://www.monogrambio.com
CONTACT:
Alfred G. Merriweather, Chief Financial
Officer of Monogram Biosciences, Inc., +1-650-624-4576,
amerriweather@monogrambio.com; or Jeremiah Hall of Feinstein Kean
Healthcare for Monogram Biosciences, Inc., +1-415-677-2700,
jeremiah.hall@fkhealth.com
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