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8-K - CURRENT REPORT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_feb122018.htm |
Exhibit 99.1
MabVax Therapeutics Announces Positive Interim Data from Expanded
Cohort in Phase 1 Trial Evaluating MVT-5873 in Combination with
First-Line Chemotherapy in Pancreatic Cancer
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All treated patients had measurable tumor reductions
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Promising early results merit additional enrollment
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Company aiming to establish the potential of combination of
MVT-5873 with first line therapy in pancreatic cancer
SAN DIEGO, February 12, 2018 – MabVax Therapeutics
Holdings, Inc. (Nasdaq: MBVX),
a clinical-stage biotechnology company focused on the development
of antibody-based products to address unmet medical needs in the
treatment of cancer, announced today positive interim results from
the Company’s ongoing Phase 1 trial evaluating
MVT-5873
in combination with standard of care
chemotherapy in patients newly diagnosed with pancreatic and other
CA19-9 positive malignancies. At the dose tested, all six patients
in the cohort had meaningful reductions in tumor volume by
RECIST.
In the Phase 1 study, MabVax’s MVT-5873, a fully human
antibody, was given in combination with nab-paclitaxel and
gemcitabine to patients newly diagnosed with CA19-9 positive
pancreatic cancer. MVT-5873 at a dose of 0.125 mg/kg when added to
first-line chemotherapy was generally well tolerated by all
subjects. The Company reported that all six patients had measurable
tumor reductions, with four patients meeting the criteria for
partial response (PR) and two patients meeting the criteria for
stable disease (SD). These results help confirm results reported
from a group of patients treated earlier. Patient CA19-9 levels,
which are a prognostic indicator of the disease state, were
markedly reduced in all subjects with this combination therapy. The
Company plans to enroll additional patients at this dose to further
explore safety and potential response.
“We are highly encouraged by the continued positive response
across all of the initial patients at this dose of MVT-5873. We are
enrolling additional patients at this dose level to confirm our
early clinical results with a goal to determine if these clinically
meaningful initial results can continue to be replicated in a
larger patient population. With additional confirmatory data, we
could establish the potential of combining MVT-5873 with first line
therapy in very difficult to treat cancer patients,”
commented David Hansen, MabVax's
President and Chief Executive Officer.
This Phase 1 clinical trial is an open-label, multi-center
nonrandomized study evaluating the safety and recommended Phase 2
dose of MVT-5873 in combination with a standard of care
chemotherapy in subjects with pancreatic and other CA19-9 positive
malignancies. Secondary objectives include evaluating tumor
response rate by RECIST 1.1, duration of response, and to determine
pharmacokinetics. This study utilizes a conventional 3+3 design to
identify the recommended Phase 2 dose. Dr. Eileen O'Reilly,
Associate Director of the David M. Rubenstein Center for Pancreatic
Cancer Research, attending physician, member at Memorial Sloan
Kettering Cancer Center and Professor of Medicine at Weill Cornell
Medical College is the lead investigator in the MVT-5873 Phase 1
clinical trial.
For additional information about the Phase 1 MVT-5873 clinical
trial, please visit clinicaltrials.gov,
and reference Identifier NCT 02672917.
About MabVax:
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, Sarah Cannon Research Institute, Honor Health 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 and specificity for the
target. 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 positive interim data from an expanded
cohort in a phase 1 trial evaluating MVT-5873 in combination with
first-line chemotherapy in pancreatic cancer patients 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 these results can continue to be replicated in a
larger patient population. 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
Media Contact:
Travis Kruse, Ph.D.
Russo Partners LLC
Phone: 212-845-4272
Email: travis.kruse@russopartnersllc.com