On June 7, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, reported 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 (Press release, MabVax, JUN 7, 2016, View Source [SID:1234513112]). 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).
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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."
About HuMab-5B1:
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).