SAN DIEGO, July 18, 2016 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, announces the initiation of patient enrollment at Memorial Sloan Kettering Cancer Center (MSK) in a Phase I clinical trial evaluating its new generation diagnostic PET imaging agent, MVT-2163 for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. This study follows another investigational Phase I trial recently initiated at MSK utilizing the Company's HuMab-5B1 antibody MVT-5873 as a therapeutic product for the treatment of Pancreatic cancer.
The diagnostic imaging study will administer MVT-2163 as a PET imaging agent for patients with pancreatic cancer. 89Zr-HuMab-5B1 combines a well-established PET imaging radiolabel, Zirconium [Zr-89], with the targeting specificity of the Company's HuMab-5B1 antibody. This clinical trial will evaluate the safety, pharmacokinetics and biodistribution of MVT-2163 in patients with pancreatic cancer. The trial will also determine the ideal dose and timing for an optimal PET scan image. Preclinical xenograft animal models demonstrated high image resolution of tumors, making MVT-2163 attractive as a potential companion diagnostic agent for use with the MVT-5873 therapeutic product. Some of the preclinical data supporting the development of this new agent was funded by the National Cancer Institute contract (HHSN261201300060C) and previously published in the Journal of Nuclear Medicine, Bioconjugate Chemistry, and the Proceedings of the National Academy of Sciences. This study is under the direction of Dr. Christian Lohrmann as lead investigator who has received a grant from a non-profit foundation to help support this clinical trial.
"We are very excited to begin patient enrollment for this Phase I trial at MSK," said David Hansen, MabVax President and CEO. "We expect to see in the next few weeks the first PET images from this study establishing the level of targeting specificity of the HuMab-5B1 antibody. The results of our study are intended to provide investigators with a better understanding of the cancers afflicting these patients. If the product produces the desired images, it could help improve diagnosis and physician decision making on treatment options for pancreatic cancer and other CA19-9 positive malignancies. We look forward to announcing interim results from this trial during the third quarter of 2016."
MabVax's HuMab-5B1 antibody is fully human and was discovered from the immune response of cancer patients vaccinated with an antigen-specific vaccine during a Phase I trial at Memorial Sloan Kettering Cancer Center. In preclinical research, the 5B1 antibody has demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers. The antigen the antibody targets is expressed on more than 90% of pancreatic cancers making the antibody potentially broadly applicable to most patients suffering from this type of cancer. MabVax's two lead antibody clinical programs utilize HuMab-5B1 as a naked antibody (MVT-5873) and as an immuno-PET imaging agent (MVT-2163).
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of antibody-based products to address unmet medical needs in the treatment of cancer. MabVax has discovered a pipeline of human monoclonal antibody products based on the protective immune responses generated by patients who have been immunized against targeted cancers with the Company's proprietary vaccines. MabVax also has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax also has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials. Additional information is available at www.mabvax.com.
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This press release contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to the Company's clinical trials and product development pipeline. We have no assurance that all of the product development pipeline will be fully developed by the Company. 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," "hope" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon current expectations of the Company 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. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release relating to the Company may be found in the Company's periodic filings with the Securities and Exchange Commission, including the factors described in the section entitled "Risk Factors" in its annual report on Form 10-K for the fiscal year ended December 31, 2015, as amended and supplemented from time to time and the Company's Quarter Reports on Form 10-Q and other filings submitted by the Company to the SEC, copies of which may be obtained from the SEC's website at www.sec.gov. The parties do not undertake any obligation to update forward-looking statements contained in this press release.
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