On November 28, 2016 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical stage immuno-oncology drug development company, reported that the first patients have been treated with MVT-5873, the company’s therapeutic antibody, in combination with a standard of care chemotherapy in a previously untreated pancreatic cancer patient population (Press release, MabVax, NOV 28, 2016, View Source [SID1234516816]). The company recently reported that it had established sufficient safety and tolerability utilizing MVT-5873 as a monotherapy in relapsed or refractory locally advanced or metastatic pancreatic cancer patents to initiate the expansion into first line treatment. Schedule your 30 min Free 1stOncology Demo! On November 14th of this year the company reported that the safety of MVT-5873 has been established during administration as monotherapy at three incremental dose levels in relapsed or refractory locally advanced or metastatic pancreatic cancer patents. As specified in the protocol, once safety and tolerability have been established, the second part of the phase I trial investigating MVT-5873 in combination with a standard of care chemotherapy using nab-paclitaxel plus gemcitabine could be initiated. Patients are now being enrolled in the first of successive incremental dose levels to access safety and tolerability when used in combination with chemotherapy and to ultimately establish a recommended phase II dose (RP2D) when used in combination.
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In addition patients continue to be recruited into the monotherapy portion of the trial to establish the RP2D in monotherapy in relapsed or refractory locally advanced or metastatic pancreatic cancer patents. Since the announcement in mid-November, three monotherapy patients have been treated with the next incremental dose.
"From the outset we have been working toward expanding our clinical program into treatment of newly diagnosed patients in combination with a standard of care chemotherapy," stated President and CEO J. David Hansen. He added, "Pancreatic cancer is an extraordinarily difficult disease to treat and our evaluation of MVT-5873 in combination with a front line chemotherapy provides a potential new opportunity for treatment of the disease. We designed our preclinical studies to assess the synergistic effect of adding MVT-5873 to a standard chemotherapy treatment regimen. We reported positive results from those studies and demonstrated a dose dependent positive response. We are looking forward to presenting the results from both the dose expansion portions of the monotherapy and combination with chemotherapy trials mid-year 2017."