MabVax Therapeutics Receives FDA Authorization for Phase I Clinical Trial with 89Zr-HuMab-5B1 as PET Imaging Agent for Pancreatic Cancer

SAN DIEGO, Feb. 1, 2016 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX), a clinical-stage oncology drug-development company, announces receipt of notice from the U.S. Food and Drug Administration (FDA) authorizing initiation of a Phase I clinical trial with ⁸⁹Zr-HuMab-5B1 as a new generation PET scan cancer imaging agent in patients with pancreatic cancer.  The Company filed an Investigational New Drug (IND) application for this trial with the FDA on December 29, 2015.  MabVax previously announced receipt of FDA authorization for a Phase I trial with HuMab-5B1 as a therapeutic treatment for patients with pancreatic cancer, and patient enrollment in both Phase I trials is expected to commence in the first quarter of 2016.

The Phase I clinical trial with ⁸⁹Zr-HuMab-5B1 is designed to enroll up to 28 patients previously diagnosed with pancreatic cancer, who will be administered ⁸⁹Zr-HuMab-5B1. Patients will return for additional visits on days 2, 4 and 7 for imaging and safety assessments. The trial will evaluate the safety, pharmacokinetics and biodistribution of ⁸⁹Zr-HuMab-5B1, as well as determine the ideal dose and conditions for an optimal PET scan image.  MabVax expects to report the initial set of images from this trial by mid-year 2016 and anticipates that patient enrollment will be completed before the end of 2016. 

The ⁸⁹Zr-HuMab-5B1 imaging agent is MabVax's HuMab-5B1 fully human antibody conjugated to a radioactive label.  It is being developed to take advantage of the antibody's ability to target pancreatic cancer cells and attach to pancreatic tumors to improve their detection.  ⁸⁹Zr-HuMab-5B1 has demonstrated high-resolution images of tumors in xenograft animal models and results of advanced preclinical study were published in the peer-reviewed Journal of Nuclear Medicine on September 12, 2013.  Additionally, MabVax has received $1.75 million from the National Institutes of Health (NIH) for the development of ⁸⁹Zr-HuMab-5B1 as an imaging agent for pancreatic cancer.  ⁸⁹Zr-HuMab-5B1 also has the potential as a companion diagnostic for MabVax's HuMab-5B1 therapeutic product.   

"Our HuMab-5B1 products represent a novel approach to harnessing the immune system to diagnose and treat cancer, and we are delighted with the FDA's expeditious response to our IND filings," said David Hansen, MabVax's President and Chief Executive Officer.  "We expect to report interim data from both Phase I trials by the middle of this year, which could have a positive impact on our future commercial and corporate development activities.  We also plan to pursue additional programs with HuMab-5B1 as well as follow-on antibodies under development at MabVax that have the potential for dual-product applications for additional types of cancer."

About HuMab-5B1

MabVax's 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 has 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.

Investor Contact:

Jody Cain
Senior Vice President
LHA
310-691-7100
[email protected]

SOURCE MabVax Therapeutics Holdings, Inc.

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