MabVax Therapeutics Files IND for a Phase I Clinical Trial with 89Zr-HuMab-5B1

Enrollment in Trial with New PET Imaging Agent Expected to Begin in Early 2016

Jan 06, 2016, 08:00 ET from MabVax Therapeutics Holdings, Inc.

SAN DIEGO, Jan. 6, 2016 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug development company, announces the filing of an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for 89Zr-HuMab-5B1, the Company's fully human antibody product, as a new generation PET scan cancer imaging agent.  Subject to FDA authorization to proceed, MabVax plans to initiate the Phase I clinical trial in patients with pancreatic cancer in early 2016.  

The 89Zr-HuMab-5B1 imaging agent has demonstrated high-resolution images of tumors in xenograft animal models, potentially making it an important new tool to aid in the diagnosis, monitoring and assessment of pancreatic cancer patients and an attractive companion diagnostic for the HuMab-5B1 therapeutic product.  In December 2015, MabVax received the FDA's authorization to proceed with HuMab-5B1 in a Phase I trial as a therapeutic treatment for patients with pancreatic cancer.

This second planned Phase I trial will evaluate the safety, pharmacokinetics and biodistribution of 89Zr-HuMab-5B1 in cancer patients.  The trial will also determine the ideal dose and conditions for an optimal PET scan image using the new imaging agent.  

David Hansen, MabVax's President and Chief Executive Officer, said, "With the submission of this second IND in late December, we have achieved our objective of filing both INDs for our HuMab-5B1 based products during 2015.  We are making preparations to begin the Phase I trial with HuMab-5B1 as a therapeutic agent and, subject to FDA authorization to proceed with this second clinical trial, will begin dosing our first patients in the 89Zr-HuMab-5B1 Phase I trial soon thereafter."

"We anticipate that the Phase I trial with 89Zr-HuMab-5B1 will produce an initial set of images by mid-year 2016.  This will be an important interim milestone in our continued development of this diagnostic product and could have a positive impact on our future commercial and corporate development activities.  We expect to complete patient enrollment in this trial before the end of 2016," added Mr. 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-5B1:
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.  In preclinical research, the HuMab-5B1 antibody demonstrated high specificity and affinity, and has shown potent cancer cell killing capacity and efficacy in animal models of pancreatic, colon and small cell lung cancers.  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. 

About MabVax:
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 filing on an IND and product 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.

 

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SOURCE MabVax Therapeutics Holdings, Inc.



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