SAN DIEGO, Oct. 21, 2014 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) a clinical stage oncology drug development company, announced today that it has formally nominated its HuMab 5B1 antibody as a clinical candidate for the diagnosis and treatment of pancreatic and colon cancer. The fully human antibody, recovered from patients undergoing cancer vaccine treatment at Memorial Sloan-Kettering Cancer Center, has entered GMP manufacturing to produce clinical trial supplies for a planned Phase 1 program to begin in the second half of 2015. The development plan calls for dual Phase 1 clinical trials to take place simultaneously. One program will be aimed at demonstrating the utility of the radio-labeled antibody as a novel PET imaging agent for the diagnosis and management of pancreatic cancer. The second program will determine the safety and potential utility of the full-length antibody as a treatment for the same cancer.
About HuMab 5B1
The HuMab 5B1 has demonstrated high specificity, affinity, and lack of cross-reactivity with similar antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon, and small cell lung cancer. Early toxicology results continue to produce an acceptable profile in acute and repeat dose toxicology models. The antibody, when combined with a radio-label as a novel PET imaging agent, has demonstrated high image resolution of tumors in established animal models. The company believes that the HuMab 5B1 antibody met all of the Company's criteria for moving the product forward as a clinical development candidate.
About MabVax Antibody Discovery Technology
MabVax has developed an antibody discovery technology that surveys the protective immune response from many patients by examining blood samples to identify the ideal monoclonal antibody candidate against a specific target. We believe our approach to antibody discovery identifies antibody candidates with superior performance characteristics while minimizing many of the toxicity and drawbacks of other discovery technologies. The company's highly experienced researchers have utilized this technology to discover fully-human antibodies to a wide range of targets including antigens on cancer cells, bacteria, viruses, and toxins. While the company's technology is suitable to discover fully-human antibodies to highly infectious agents such as the Ebola virus, in response to recent inquiries, it does not have the specialized laboratory infrastructure to allow such an effort.
MabVax Therapeutics Holdings, Inc. is a clinical stage biotechnology company focused on the development of vaccine and antibody based therapies 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 has two cancer vaccines targeting recurrent sarcoma and ovarian cancer in proof of concept Phase II multi-center clinical trials, and a vaccine targeting neuroblastoma ready for Phase II clinical development.
Additional information about the Company 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 development pipeline and stock symbol. 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, 2013 and in the Proxy Statement dated July 25, 2014, as amended and supplemented from time to time and in our quarterly report on Form 10-Q for June 30, 2014. 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.