On January 9, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, reported the filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody radioimmunotherapy (RIT) (Press release, MabVax, JAN 9, 2017, View Source [SID1234517341]). Subject to receiving FDA authorization to proceed, MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies early in 2017. This is the third IND filed by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

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The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

In November 2016, MabVax reported positive interim results from two phase I trials. The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating 16 patients at three clinical sites. Patients continue to be recruited to establish the recommended phase II dose (RP2D). The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution in the initial two cohorts of patients: the first cohort was administered MVT-2163 alone; and the second cohort was given MVT-2163 following administration of MVT-5873. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.

David Hansen, MabVax’s President and Chief Executive Officer, said, "Following the positive interim data readout from our two ongoing phase I trials, we are excited to take this next step forward in our development strategy. Subject to receiving FDA authorization to proceed, we plan on expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent. We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers."