Sufficient safety established in monotherapy portion of phase I trial to initiate the evaluation of MVT-5873 as a front-line therapy in combination with a standard of care chemotherapy
SAN DIEGO, Nov. 28, 2016 /PRNewswire/ -- 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. 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.
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.
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."
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 vaccinated against targeted cancers with the Company's proprietary vaccines. 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. 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. Additional information is available at www.mabvax.com.
Forward Looking Statements
This press release contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to the company's progress in its two phase I clinical trials of MVT-5873 and MVT-2163, and plans for 2017. 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, and the Company's Quarterly Reports on Form 10-Q, as such filings may be amended and supplemented from time to time, and other filings and reports by the Company with 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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SOURCE MabVax Therapeutics Holdings, Inc.
Released November 28, 2016