MabVax Therapeutics to Present Positive Development Study Results Enabling Manufacturing of Two Radionuclide Products for Phase 1 Clinical Trials at the 2017 AAPS Annual Meeting
SAN DIEGO, Nov. 13, 2017 /PRNewswire/ -- MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer, announced today the results from the manufacturing process development and characterization of the Company's immunoPET imaging agent (MVT-2163) and radioimmunotherapy agent (MVT-1075) which are being evaluated in advanced pancreatic cancer and other CA19-9 positive cancers. The results will be presented in a poster presentation at the American Association of Pharmaceutical Scientists to be held in San Diego, CA, November 12 - 15, 2017.
Paul W. Maffuid, PhD, Executive Vice President of Research and Development at MabVax, will present the development and characterization studies that were performed to establish a reproducible process for the manufacture of the Company's immunoPet imaging agent and radioimmunotherapy drug product.
Title of Presentation: Characterization of the HuMab-5B1 antibody conjugated with bi-functional agents clinically demonstrated as radioisotope chelators.
Poster Number: M5094
Location: Manufacturing Process / Scale-up and Optimization
Session Date: Monday, November 13
Time: 1:00 PM to 2:00 PM (Pacific Time)
"These studies were critical to establish a well-defined manufacturing process for the reproducible delivery of a well characterized investigational drug product to our clinical sites," remarked David Hansen, CEO of MabVax. He added, "These results demonstrate that our HuMab-5B1 antibody is readily conjugated without diminishing its target specificity. Earlier this year the Company reported results from our Phase 1a clinical trial with our immunoPet imaging agent MVT-2163 where radiotracer uptake above background was observed in primary tumors and metastases from day 2 and continuously increased through day 7 of the study. The data from our imaging trial has provided significant insight into our development strategy for the MVT-1075 program."
The MVT-1075 Phase 1 first-in human clinical trial is an open-label, multi-center study evaluating the safety and efficacy in up to 22 patients for patients with locally advanced or metastatic adenocarcinoma of the pancreas ("PDAC") or other CA19-9 positive malignancies including colon and lung cancers. The primary objective is to determine the maximum tolerated dose and safety profile in late stage patients with recurring disease who have failed prior therapies. Secondary objectives include evaluating tumor response rate and duration of response by RECIST 1.1, and determining dosimetry and pharmacokinetics. This dose-escalation study utilizes a traditional 3+3 design. The study is currently enrolling subjects at Memorial Sloan Kettering and HonorHealth.
About MabVax Therapeutics Holdings, Inc.
MabVax Therapeutics Holdings, Inc. is a clinical-stage biotechnology company with a fully human antibody discovery platform focused on the rapid translation into clinical development of products to address unmet medical needs in the treatment of cancer. Our antibody MVT-5873, is a fully human IgG1 monoclonal antibody (mAb) that targets sialyl Lewis A (sLe(a)), an epitope on CA19-9, and is currently in Phase 1 clinical trials as a therapeutic agent for patients with pancreatic cancer and other CA19-9 positive tumors. CA19-9 is expressed in over 90% of pancreatic cancers and in other diseases including small cell lung and GI cancers. CA19-9 plays an important role in tumor adhesion and metastasis, and is a marker of an aggressive cancer phenotype. CA19-9 serum levels are considered a valuable adjunct in the diagnosis, prognosis and treatment monitoring of pancreatic cancer. With our collaborators including Memorial Sloan Kettering Cancer Center, Rockefeller University, Sarah Cannon Research Institute, HonorHealth and Imaging Endpoints, we have treated over 50 patients with either our therapeutic antibody designated as MVT-5873 or our PET imaging diagnostic product designated as MVT-2163 in Phase 1 clinical studies, and demonstrated early safety, specificity for the target and a potential efficacy signal. Patient dosing has commenced for our lead development program in Phase 1 clinical study of the Company's radioimmunotherapy product MVT-1075. For additional information, please visit the Company's website, www.mabvax.com.
Forward Looking Statements:
This press release on announcing the business outlook for the Company contains "forward-looking statements" regarding matters that are not historical facts, including statements relating to the Company's clinical trials and product development pipeline. We have no assurance that 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, 2016, 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:
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: jtc@jenenethomascommunications.com
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SOURCE MabVax Therapeutics Holdings, Inc.
