SOUTH SAN FRANCISCO, Oct. 22 /PRNewswire-FirstCall/ -- Monogram Biosciences, Inc. today announced that Monogram scientists have made presentations related to its expanding set of VeraTag assays at the 20th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Geneva, Switzerland.
The first presentation, entitled "Development of proximity-based immunoassays for activated HER1, HER2, and HER1:2 heterodimers in formalin-fixed, paraffin-embedded cells", outlines the development of sensitive and specific assays in fixed tumor cell lines. The second presentation, entitled "Development of highly quantitative, sensitive and reproducible assays for the detection of HER1 and HER3 in formalin-fixed, paraffin-embedded tumor tissue", describes the validation of these assays as providing quantitative and accurate measurements in human tumor tissue.
"EGFR/HER receptors are known to be significant to the proliferation of many different cancers," said William Young, Monogram chief executive officer. "HERmark(TM), our recently launched breast cancer assay, is bringing new options to breast cancer patients with quantitative measurements of HER2 total protein and HER2:HER2 homodimer. This week's presentations in Geneva evidence Monogram's expanding portfolio of assays and the growing reach of the VeraTag(TM) technology."
"With our VeraTag platform, we can make precise and quantitative measurements of protein complexes that have not previously been possible," said Gordon Parry, Ph.D., Monogram vice president of research & development, oncology. "The data presented this week, on the HER1 and HER3 total protein assays, the HER1:HER1 homodimer assay and the activated HER1:HER2 heterodimer assay, provide support for the use of these assays in drug development programs not only in breast cancer, our current focus, but also in other cancer types."
In addition to the assays featured in this week's presentations, Monogram has assays in advanced development for quantifying HER2:HER3 heterodimers, HER3:PI3K complex, a key downstream signaling complex in the Akt pathway, and p95, a truncated form of HER2, for use in formalin-fixed, paraffin embedded tumors. Measurements of these proteins or protein complexes in a patient's tumor may provide valuable information on the key signaling pathways driving tumor growth as well as potential mechanisms of drug resistance. "This information is expected to inform the rational design of combination therapies in a very wide range of cancers," added Parry. "In breast cancer for example, expression of certain of these protein markers may predict resistance to Herceptin(R) and indicate the potential need for additional drugs that act by different mechanisms in these patients."
Several additional presentations related to Monogram's VeraTag assays will be made in 2008. Data on the HER2:HER3 heterodimer assay and the HER3:PI3K complex assay will be presented at the AACR "Targeting the PI3-Kinase Pathway in Cancer" meeting in Cambridge, MA in November. Clinical data on HERmark, Monogram's commercially available HER2 and HER2:HER2 homodimer assay, will be presented at the Chemotherapy Foundation Symposium in New York in November and at the San Antonio Breast Cancer Symposium in December.
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 www.monogrambio.com.
Forward Looking Statements
Certain statements in this press release are forward-looking, including statements regarding the demand for and performance of our products, including our HERmark and VeraTag assays, the potential for enhancements to our HERmark assay, the development of additional assays based on the VeraTag platform, the results and timing of clinical studies on our products and the presentation or publication of data from such studies. 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 and acceptance of our products; the risk that our VeraTag assays, including HERmark, 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, the risk that our VeraTag technology may not accurately measure other proteins or protein complexes, 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; expected reliance on a few customers for the majority of our revenues; 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, including HERmark; whether the draft guidance on Multivariate Index Assays issued by the 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, G.E. and other debt agreements; potential Nasdaq proceedings to delist our common stock, our ability to regain compliance with Nasdaq listing requirements, the impact of a possible reverse split of the shares of our common stock, 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.
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, +1-415-677-2700,
jeremiah.hall@fkhealth.com
Web site: http://www.monogrambio.com/
