Monogram Biosciences Announces HER2:HER3 Heterodimer and HER3/PI3K VeraTag Assays Are Now Available for Use in Development of Cancer Therapeutics

Assays for HER2, HER3 and Related Protein Complexes May Provide Unique Insights to Guide Combination Therapy in Breast and Other Cancers

SOUTH SAN FRANCISCO, Calif.--()--Monogram Biosciences, Inc. (Nasdaq:MGRM) today announced that additional EGFR/HER assays have been successfully tested in sets of fixed human tumors and are now available for use in drug development programs. These assays provide quantitative measurements of the HER2:HER3 heterodimer, and its associated downstream HER3:PI3K complex. An assay for p95, a truncated form of HER2, is in advanced development. These assays provide a measure of the activation state of key signaling pathways in tumors and may help predict patients responses to novel cancer therapeutics in development as well as potentially predict resistance to currently available drugs.

HERmark, Monograms HER2 and HER2:HER2 Homodimer Breast Cancer Assay, is available through Monograms CAP-certified clinical reference laboratory and provides accurate, quantitative measurements of a patients HER2 status, which is believed to be an indicator of the likelihood of response to Herceptin.

We are excited to make the HER2:HER3 heterodimer and HER3:PI3K assays available for clinical trial use, complementing the HER1 and HER3 total protein assays that are already available, said William Young, president and CEO of Monogram Biosciences. These additional assays will not only expand the range of Monograms assays applicable to breast cancer, but also provide assays for key signaling pathways driving additional tumor types. Understanding these protein markers is expected to inform the rational design of combination therapies, such as those for breast cancer patients with resistance to Herceptin.

There is a significant amount of in vitro data suggesting that resistance to targeted inhibition of HER2 may be mediated by activation of the PI3K pathway, said Michael Bates, M.D., Monograms vice president of clinical research. However, it has been difficult to assess the PI3K pathway in vivo until now. Accurate, quantitative measurements of proteins and protein complexes such as HER3 expression, HER2:HER3 heterodimers, and the HER3:PI3K protein complex represent significant opportunities to interrogate and hopefully unravel the complex biology underlying breast cancer and other cancers that rely on signaling through the PI3K pathway. Monogram will be using these new assays in current and planned patient cohorts to compare the levels of these protein complexes with drug response.

These assays enable us to make accurate and quantitative measurements of protein complexes in patients tumors in a way that has not previously been possible. We anticipate that they will be extremely valuable in drug development programs focused on novel drugs targeting HER pathways, said Gordon Parry, Ph.D., Monogram vice president of research & development, oncology. Data on the HER3:PI3K assay will be presented this week at the AACR Targeting the PI3-Kinase Pathway in Cancer meeting in Cambridge, MA and data on the HER2:HER3 heterodimer assay will be presented 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; 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

Monogram Biosciences, Inc.
Alfred G. Merriweather, 650-624-4576
Chief Financial Officer
amerriweather@monogrambio.com
or
Feinstein Kean Healthcare
Jeremiah Hall, 415-677-2700
jeremiah.hall@fkhealth.com

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Contacts

Monogram Biosciences, Inc.
Alfred G. Merriweather, 650-624-4576
Chief Financial Officer
amerriweather@monogrambio.com
or
Feinstein Kean Healthcare
Jeremiah Hall, 415-677-2700
jeremiah.hall@fkhealth.com