On May 16, 2016 MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, reported that its lead cancer therapeutic HuMab-5B1 (MVT-5873) was featured in a poster presentation on May 13th at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer: Advances in Science and Clinical Care, held in Orlando, Florida (Press release, MabVax, MAY 16, 2016, View Source [SID:1234512427]). MVT-5873 is currently being evaluated in an open-label, multicenter, dose-escalation Phase I clinical trial as a single agent and in combination with gemcitabine/nab-paclitaxel in patients with metastatic pancreatic cancer.
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"The poster presentation provides compelling data as to the potential benefits of combining MVT-5873 with the standard of care chemotherapeutic regimen gemcitabine/nab-paclitaxel (Abraxane) for patients with advanced pancreatic cancer," said David Hansen, CEO of MabVax. "In this study, MVT-5873 administered as a single agent demonstrated antitumor activity in a xenograft mouse model of human pancreatic cancer. Moreover, when combined with gemcitabine/nab-paclitaxel, MVT-5873 potentiated the anti-tumor activity of the chemotherapy. Importantly, MVT-5873 activity in these models was demonstrated at doses clinically relevant to our ongoing Phase I trial in patients with metastatic pancreatic cancer."
The poster "Antitumor activity of MVT-5873, a monoclonal antibody targeting sialyl Lewisa, alone and in combination with gemcitabine/nab-paclitaxel in a BxPC3 human pancreatic cancer xenograft model," (Ragupahti, et al.) was presented by Paul Maffuid, Ph.D., Executive Vice President of Research and Development of MabVax. The study data showed that in a BxPC3 human pancreatic cancer model, MVT-5873 potentiates the activity of a standard of care regimen for patients. The results of the investigation include a comparison of pharmacokinetics and pharmacodynamics and provide evidence for tumor absorption. These data are substantiated by IHC studies that indicate specific binding of MVT-5873 to BxPC3 tumor tissues, with uptake intensified relative to dose administration.
"It is exciting to further accumulate data validating our fully human antibody approach to cancer therapeutics and to present these data at the AACR (Free AACR Whitepaper) Special Meeting on Pancreatic Cancer," added Mr. Hansen. "We expect to begin a second Phase I trial later this month, with this trial evaluating MVT-2163, also based on our HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. We anticipate reporting preliminary data from both Phase I trials during the third quarter of this year. In addition we are planning to enroll patients in the second half of this year."