SAN DIEGO, Nov. 3, 2015 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, announces it has completed manufacturing of the bulk clinical-quality drug substance of HuMab 5B1 in preparation for the planned initiation of two Phase I clinical trials with this antibody in early 2016. The bulk clinical material was manufactured under Good Manufacturing Practices (GMP), has cleared all testing and has been released to be packaged into finished product.
Paul Maffuid, Ph.D., Vice President of Development and Operations of MabVax, said, "We are pleased to have completed the manufacture of the first lot of GMP bulk drug substance which is a tribute to our staff and collaborators who aided in this effort. Production of finished drug product and the information generated during this campaign are essential components of our two Investigation New Drug (IND) submissions planned for later this year."
The first Phase I trial will evaluate the safety and utility of HuMab 5B1 as a therapeutic in subjects with metastatic pancreatic cancer as a single agent or in combination with the current standard-of-care chemotherapy regimen. The second Phase I trial will be aimed at demonstrating the utility of 89Zr-HuMab 5B1, a radiolabeled HuMab 5B1 antibody, as a next-generation PET imaging agent for the identification, imaging and monitoring of pancreatic cancer.
"We believe the safety and targeting specificity data generated in the early portions of these two Phase I trials will validate the utility of the HuMab 5B1 antibody in this devastating disease," said MabVax's President and Chief Executive Officer David Hansen. "We are excited about the potential applicability of our dual-product development approach in other cancers with HuMab 5B1, as well as with follow-on antibodies under development at MabVax."
About HuMab 5B:
In preclinical research MabVax's HuMab 5B1 antibody has demonstrated high specificity, affinity and lack of cross-reactivity with closely related antigens. The antibody has also shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancer. When combined with a radio-label as a novel PET imaging agent, 89Zr-HuMab 5B1 has demonstrated high image resolution of tumors in established xenograft animal models, making it attractive as a companion diagnostic for the therapeutic product.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company focused on the development of vaccine and antibody-based products and vaccines 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 also 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 multicenter clinical trials, and a vaccine targeting neuroblastoma that will be ready for a Phase II clinical trial in 2016. 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 development pipeline. 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, 2014, 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.
SOURCE MabVax Therapeutics Holdings, Inc.