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MabVax Therapeutics, Inc. Receives $1,750,000 Small Business Innovation Research Contract Award From National Cancer Institute to Support Development of Novel Pancreatic Cancer Diagnostic Imaging Agent


9/24/2013 9:51:59 AM

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SAN DIEGO, Sept. 24, 2013 /PRNewswire/ -- MabVax Therapeutics, Inc., a privately held clinical stage biotechnology company focused on the development of innovative vaccine and antibody based therapies to treat cancer, announces that it has received Contract No. HHSN261201300060C from the National Cancer Institute, National Institutes of Health, under the Small Business Innovation Research Technology Program (SBIR). The award is in the amount of $1,750,000 over the next three years subject to satisfactory progress and continued availability of funds in the SBIR program. The grant will support development of a novel positron emission tomography (PET) imaging product for the diagnosis, staging, and treatment assessment of pancreatic cancer. The product, an antibody fragment linked to a radioactive tracer, is based on the company's discovery of a human antibody designated 5B1 that binds to a cancer antigen expressed on pancreatic cancer.

Pancreatic ductal adenocarcinoma (PDAC or pancreatic cancer) is a leading cause of cancer-related mortality worldwide primarily due in part to late stage diagnosis stemming from the lack of an early diagnostic screening tool. It is the fourth most common cause of cancer-related death in the United States with 36,800 deaths reported in 2010. Five-year relative survival rates have changed very little in the last 40 years.

The carbohydrate antigen sialyl-Lewisa (sLea) is expressed on pancreatic colon and stomach cancers cells at high levels where it is used as a tumor marker and presents an attractive molecular target. sLea facilitates tumor adhesion and extravasation that are key events for tumor metastasis, and thus presents a marker for the very cells that cause cancer recurrence. Increased sLea expression on tumors is correlated with poor clinical outcome. MabVax Therapeutics has generated fully human monoclonal antibodies against sLea with unusual high affinity for this carbohydrate ligand. MabVax discovered the 5B1 anti-sLea antibody from a patient who was vaccinated with a sLea anti-cancer vaccine.

While the intact 5B1 antibody shows promise as a PET imaging agent in an animal model, the use of antibody fragments (5B1 diabodies) is expected to provide additional benefits over intact 5B1. The 5B1 diabody is expected to show increased clearance from negative tissues and increased tumor retention thereby increasing the signal-to-noise ratio and tumor specificity. A shorter half-life (i.e. days vs. weeks) also allows clearance of tracers within 1-2 weeks and facilitates unobstructed repeat imaging with the same agent.

There is a clear need for new diagnostic tools that allow earlier detection and for improved therapy regiments. The radiolabeled 5B1 diabody represents the only human derived agent in development specifically aimed at improving imaging in pancreatic cancer. Since the antigen targeted by the 5B1 diabody is significantly and preferentially over expressed on metastatic pancreatic cancer, this development effort represents a potentially important step forward in the diagnosis, staging, and assessment of the majority of pancreatic cancer patients. The company believes that the market opportunity for a 5B1 diabody-based radiopharmaceutical is significant. The ability of physicians to accurately diagnose, stage, and assess treatment outcomes in pancreatic cancer would be very important. Additionally, accurate determinations on extent of disease and resectability are essential to improve outcomes in this cancer. Patients diagnosed with pancreatic cancer could benefit from scans conducting with this new product because of the improvement in the sensitivity and specificity of this key diagnostic tool resulting in a significant impact on clinical outcome.

About MabVax Therapeutics, Inc.
MabVax Therapeutics, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies to address unmet medical needs in the treatment of cancer. MabVax is creating a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers. The company is based in San Diego, CA. MabVax recently closed its third round of Series B venture financing in July of this year.

Forward Looking Statements

This press release contains "forward-looking statements" regarding matters that are not historical facts, including statements associated with MabVax's expectations regarding the results of this imaging research and the imaging product's potential commercial viability. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as "anticipates," "plans," "expects," "intends," "will," "potential" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon MabVax's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties.

SOURCE MabVax Therapeutics, Inc.



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