SAN DIEGO, June 7, 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 the Phase I clinical trial evaluating its leading clinical development product MVT-5873 (HuMab-5B1) as a therapeutic treatment for patients with locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) or other CA19-9 positive malignancies. This is the second investigational site in the Phase I trial with patient recruitment currently underway at the Sarah Cannon Research Institute in Nashville, TN. MabVax previously announced receipt of authorization to proceed on the Investigational New Drug (IND) application filed from U.S. Food and Drug Administration (FDA).
The open-label, dose-escalation Phase I therapeutic trial is evaluating the safety, tolerability and pharmacokinetics of MVT-5873. The first group of patients are being enrolled to assess safety and determine the recommended phase II dose of the antibody. A second patient group will establish the safety and dose of the antibody when administered with a standard-of-care chemotherapy. Eileen O'Reilly, MD, Associate Director for Clinical Research at MSK's David M. Rubenstein Center for Pancreatic Cancer Research, is serving as the lead investigator at the investigational site.
"We are very fortunate to have an established and productive relationship with MSK," said David Hansen, MabVax President and CEO. "With the addition of this investigational site, we are now recruiting patients in our Phase I therapeutics trial at two highly respected institutions. We continue on track to announce interim results from this trial in 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 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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