SAN DIEGO, May 19, 2016 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage immuno-oncology drug development company, announces that Paul Maffuid, PhD, Executive Vice President of Research and Development, will discuss MabVax's unique approach to the discovery of fully human antibodies to cancer antigens and the resulting lead HuMab-5B1 clinical projects in a presentation at America's Antibody Congress in San Diego on May 19-20, 2016.
Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company's lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers 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. MVT-2163 (89Zr-DFO-HuMab-5B) is the company's lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company's radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.
The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.
Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.
The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.
MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.
About MabVax: 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 immunized against targeted cancers with the Company's proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax is currently engaged in two Phase I clinical trials of fully human monoclonal antibody HuMab 5B1, both as a therapeutic agent (MVT-5873) and later this quarter as a next-generation PET imaging agent (MVT-2163). MabVax also has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials. 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 presentations at the AACR Annual Meeting. 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, as amended and supplemented from time to time and the Company's Quarter Reports on Form 10-Q and other filings submitted by the Company to 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.
Investor Contact:Jody Cain, Senior Vice President LHA310-691-7100 [email protected]
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Dr. Maffuid will outline the unique approach that MabVax has taken to the discovery of novel fully human antibodies from cancer patients vaccinated against their cancers. The discovery platform surveys the immune response of many patients by interrogating single B-cells from these patients who are producing antibodies against the intended target. These antibodies are then cloned, retaining the natively paired heavy and light chains of the antibody, and produced recombinantly. To date, MabVax has identified multiple antibodies with the selectivity, affinity, and cytotoxicity necessary to make them clinical development candidates. MVT-5873 is the company's lead clinical development product and currently in a Phase I clinical trial in patients with metastatic pancreatic cancer. MVT-5873 (HuMab-5B1) is currently being evaluated at three centers 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. MVT-2163 (89Zr-DFO-HuMab-5B) is the company's lead immuno-PET imaging agent that utilizes the targeting specificity of MVT-5873. MVT-2163 will open as an open-label, multicenter, dose-escalation Phase I clinical trial early in June. MVT-1075 (177Lu-DTPA-HuMab-5B) is the company's radioimmunotherapy agent and third clinical program from this platform. The radioimmunotherapy product is planned for introduction into the clinic early in 2017.
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The MVT-5873 Phase I trial is designed to evaluate the safety, tolerability and pharmacokinetics of MVT-5873 as a single agent or in combination with the current standard of care chemotherapy regimen in subjects with metastatic pancreatic cancer. The first cohort of patients is being enrolled in a traditional dose escalation regimen to assess safety and determine the optimal dose of the antibody. A second patient cohort will establish the safety and optimized dose of the antibody when administered with standard of care chemotherapy and a third patient cohort will be administered the optimized dose of antibody as a single agent for the treatment of patients with advanced cancer.
Dr. Maffuid will also present information regarding a second Phase I trial scheduled to begin in the next few weeks. This trial will evaluate MVT-2163, also based on HuMab-5B1 antibody, as a next-generation PET imaging agent for the diagnosis and management of patients with pancreatic cancer. When the antibody is combined with a radio-label as a novel PET imaging agent, the 89Zr-HuMab-5B1 product has demonstrated high-image resolution of tumors in established xenograft animal models, making it attractive diagnostic agent for detection of metastatic pancreatic cancer and for use in combination with the HuMab-5B1 therapeutic product.
The company is currently completing preclinical development activities to support filing an Investigative New Drug Application (IND) for MVT-1075 with the FDA later this year. A summary of preclinical data will be presented which demonstrated effectiveness in established xenograft animal models demonstrating potential as an therapeutic agent.
MabVax anticipates discussing preliminary results from both Phase I trials during the third quarter of this year.
About MabVax: 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 immunized against targeted cancers with the Company's proprietary vaccines. MabVax has the exclusive license to the therapeutic vaccines from Memorial Sloan Kettering Cancer Center. MabVax is currently engaged in two Phase I clinical trials of fully human monoclonal antibody HuMab 5B1, both as a therapeutic agent (MVT-5873) and later this quarter as a next-generation PET imaging agent (MVT-2163). MabVax also has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof-of-concept Phase II multicenter clinical trials. 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 presentations at the AACR Annual Meeting. 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, as amended and supplemented from time to time and the Company's Quarter Reports on Form 10-Q and other filings submitted by the Company to 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.
Investor Contact:Jody Cain, Senior Vice President LHA310-691-7100 [email protected]
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