Tuesday, February 02, 2016 12:52:35 AM
Phase I Trials with HuMab-5B1 as Imaging Agent and Therapeutic Treatment Expected to Begin in the First Quarter of 2016
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
jcain@LHAI.com
SOURCE MabVax Therapeutics Holdings, Inc.
Recent OPK News
- Labcorp Announces Acquisition of Select Assets of BioReference Health's Diagnostics Business • PR Newswire (US) • 03/28/2024 12:00:00 PM
- Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome • GlobeNewswire Inc. • 03/20/2024 12:00:00 PM
- Form ARS - Annual Report to Security Holders • Edgar (US Regulatory) • 03/07/2024 09:02:37 PM
- AIDS Clinical Trial Group Presents Results from Phase 1 Study of ModeX Trispecific Antibody for the Treatment and Prevention of HIV • GlobeNewswire Inc. • 03/05/2024 01:52:22 PM
- Form NT 10-K - Notification of inability to timely file Form 10-K 405, 10-K, 10-KSB 405, 10-KSB, 10-KT, or 10-KT405 • Edgar (US Regulatory) • 03/01/2024 09:05:23 PM
- NextPlat Opens OPKO Health-Branded Storefront on Alibaba's Tmall Global Platform in China on March 1st • PR Newswire (US) • 02/28/2024 02:31:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/27/2024 09:07:54 PM
- OPKO Health Reports Fourth Quarter 2023 Business Highlights and Financial Results • GlobeNewswire Inc. • 02/27/2024 09:05:00 PM
- OPKO Health to Report Fourth Quarter 2023 Financial Results on February 27, 2024 • GlobeNewswire Inc. • 02/22/2024 09:05:00 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 02/16/2024 09:53:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/09/2024 09:07:24 PM
- NextPlat Receives Initial Approvals to Launch OPKO Health-Branded Storefront on Alibaba's Tmall Global Platform in China • PR Newswire (US) • 02/05/2024 01:09:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/29/2024 08:30:14 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 01/24/2024 09:15:49 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/24/2024 09:00:39 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/17/2024 10:09:48 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/10/2024 10:56:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/09/2024 10:09:07 PM
- OPKO Health Announces Closing of Private Offering of $230 Million Convertible Senior Notes Due 2029 including Full Exercise of Initial Purchaser’s Option to Purchase Additional Notes • GlobeNewswire Inc. • 01/09/2024 09:05:28 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/08/2024 02:10:34 PM
- OPKO Health to Present at the 42nd Annual J.P. Morgan Healthcare Conference • GlobeNewswire Inc. • 01/08/2024 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2024 10:26:26 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2024 09:00:01 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2024 06:39:36 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 01/05/2024 05:42:55 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM