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 (sLea), 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.