Monogram Announces Presentation Of Clinical Data For The HERmark™ Breast Cancer Assay At The CTRC-AACR San Antonio Breast Cancer Symposium

Main Category: Breast Cancer
Also Included In: Cancer / Oncology
Article Date: 15 Dec 2008 - 4:00 PST

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Monogram Biosciences, Inc. (Nasdaq:MGRM) announced that new results from a study of the predictive power of its HERmark™ Breast Cancer Assay were presented at the CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas. An oral presentation, entitled "HER2 Protein expression and homodimer levels predict response to trastuzumab in centrally tested FISH-positive metastatic breast cancer patients", was made by Allan Lipton M.D., Professor of Medicine & Oncology at Hershey Medical Center/Penn State University.

The study assessed HERmark, Monogram's novel oncology assay, as a means to measure HER2 total protein and homodimer levels and to predict the response to treatment with Herceptin® (trastuzumab) in patients with metastatic breast cancer. Data presented today indicated that, regardless of whether they tested positively or negatively with FISH, those patients that had low HER-2 total protein expression responded to a trastuzumab-containing regimen similarly, and significantly worse than patients who had FISH-positive tumors with high HER-2 total expression. "These findings suggest that precise measurements of HER2 at the protein level add clarity to clinical decision making and represent a positive result for the HERmark assay." said Michael Bates, M.D., Monogram Vice President of Clinical Research.

Preliminary results from this study, that were previously presented at the 44th ASCO Annual Meeting in Chicago, Illinois, in June 2008, indicated that Monogram's HERmark Breast Cancer Assay was a better predictor of response to trastuzumab than FISH testing, even when conducted in a central laboratory. The preliminary results also indicated discordance between the assessments of HER2 status as measured by HERmark and FISH, such that 14% of FISH-negative patients were determined to be HER2 high expressors by HERmark and 13% of FISH-positive patients were determined to be HER2 low expressors by HERmark.

"Current testing methods for determination of the likelihood of benefit from Herceptin are not adequate," said Allan Lipton M.D., Professor of Medicine & Oncology at Hershey Medical Center/Penn State University. "Earlier this year, we presented data that showed that higher HER2 total protein and HER2 homodimer levels, as measured by HERmark, predict which patients have the best chance of responding to Herceptin, even within a population that has already been determined to be FISH+ on central laboratory testing. With the additional analyses reported today, we can further see that in the specific patients where there is discordance between the two assessments of HER2 status, the HERmark result is the one that is aligned with clinical outcome."

The study used Monogram's proprietary HERmark assay to analyze tissue samples from patients with metastatic breast cancer who were treated with Herceptin. Patients had been previously selected for Herceptin therapy by IHC or FISH testing, with most having been selected by IHC performed in a central laboratory. Subsequently, all patient samples were retested using FISH performed at a central laboratory. Using HERmark to measure HER2 total protein and HER2 homodimer levels, the results were compared with the patients' response to treatment with Herceptin.

In a separate poster presentation made earlier this week in San Antonio (Poster #1074), Monogram scientists described correlations identified (in the Penn State cohort described above) between HER2 homodimer levels, quantified by HERmark, and time to first recurrence in HER2-positive breast cancer patients who did not receive trastuzumab in the adjuvant setting.

In an additional poster presentation also made this week in San Antonio (Poster #2071), a collaborator, Heikki Joensuu, M.D., Professor of Oncology at Helsinki University Central Hospital, Helsinki, Finland described comparisons of HER2 and HER2 homodimer levels, quantified with HERmark, and HER2 status as assessed by immunohistochemistry (IHC)and chromogenic in situ hybridization (CISH) in the FinHer study. This study was a previously conducted clinical evaluation of trastuzumab in the adjuvant setting and in which HERmark is being evaluated in an ongoing study using previously stored tissue samples. "HERmark's ability to make accurate quantitative measurements of HER2 and HER2 homodimer levels provides unique new insights to the biology of breast cancer," said Heikki Joensuu, M.D. "We are excited about using this important tool to increase our knowledge of breast cancer therapy, including the important adjuvant setting."

"HERmark is the first diagnostic built upon our VeraTag technology," said Monogram CEO Bill Young. "With this week's presentations at San Antonio, we have seen further clinical analysis that supports the utility of HERmark. We have also reported data on three of our new assays - those for HER3, for the HER2:HER3 heterodimer and for the HER3:PI3K complex. These assays, along with our assay in advanced development for p95, have the potential to add further insights to breast cancer treatment and our goal is to enhance HERmark with such an additional measurement in late 2009."

About HERmark

HERmark is a proprietary diagnostic that accurately quantifies HER2 total protein expression and HER2 homodimerization 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. Assays based on the VeraTag technology platform are 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, including statements regarding the performance, potential use of and demand for 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 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.

Monogram Biosciences, Inc.