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8-K - CURRENT REPORT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_dec202017.htm |
Exhibit 99.1
MabVax Therapeutics Announces Completion of Enrollment and Initial
Patient Dosing in an Expanded Cohort of the Phase 1 Trial
Evaluating MVT-5873 in Combination with First-Line
Chemotherapy
– Company plans to announce interim safety and RECIST data Q1
2018 –
SAN DIEGO, December 20, 2017 – 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 the completion of enrollment and initial patient
dosing in an expanded cohort of the Company’s Phase 1 trial
evaluating MVT-5873 in combination with standard of care
chemotherapy in newly diagnosed patients with pancreatic and other
CA19-9 positive malignancies.
In
October, the Company provided an update at the AACR-NCI-EORTC
International Conference highlighting encouraging preliminary tumor
response data when MVT-5873 was given in combination with
nab-paclitaxel and gemcitabine in newly diagnosed patients with
CA19-9 positive pancreatic cancer. At this meeting the Company
reported that this dose was generally well tolerated in all
subjects and that two of three subjects receiving 0.125 mg/kg
MVT-5873 in combination with gemcitabine plus nab-paclitaxel had a
partial response (“PR”). The Company expanded this
cohort to further explore safety and potential response and is now
reporting that it has completed enrollment in the 0.125 mg/kg
expansion cohort.
This
portion of the Company’s Phase 1 clinical trial is an
open-label, multi-center nonrandomized dose escalation study
evaluating the safety and maximum tolerated dose
(“MTD”) 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. 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.
“We
are pleased to have completed patient enrollment of the 0.125 mg/kg
expansion cohort of our clinical development program evaluating
MVT-5873 as a first line therapy with standard of care gemcitabine
plus nab-paclitaxel. We plan to report interim safety and RECIST
results from this study in the first quarter of 2018,”
commented David Hansen, MabVax's President and Chief Executive
Officer.
For
additional information about the Phase 1 MVT-5873 clinical trial,
please visit clinicaltrials.gov, and reference Identifier
NCT02672917.
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 the completion of enrollment and
initial dosing of the last patient in the expansion cohort of the
Phase 1 clinical trial evaluating MVT-5873 for the treatment of
pancreatic and other CA19-9 positive malignancies 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 all 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:
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