MabVax receives FDA authorization to initiate 89Zr-HuMab-5B1 Phase I trial in pancreatic cancer patients

Feb 1 2016

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."