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8-K - CURRENT REPORT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_dec122017.htm |
Exhibit
99.1
MabVax
Therapeutics Announces Completion of Enrollment and Dosing in
Initial Cohort of MVT-1075 Radioimmunotherapy Phase 1 Trial for the
Treatment of Pancreatic, Colon and Lung Cancers
– Company plans on announcing
interim data in Q1 2018 –
SAN
DIEGO, December 13, 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 dosing of all patients in the initial cohort of the Phase 1
clinical trial evaluating the Company’s new human
antibody-based radioimmunotherapy (“RIT”) product
MVT-1075 for the treatment of pancreatic, colon and lung
cancer.
This Phase 1 first-in-human clinical trial is an open-label,
multi-center study evaluating the safety and efficacy of MVT-1075
in approximately 22 patients with CA19-9 positive malignancies in
the U.S. The primary objective is to determine the maximum
tolerated dose and safety profile in patients with recurring
disease who have failed prior therapies. Secondary endpoints are to
evaluate tumor response rate and duration of response by RECIST
1.1, and to determine dosimetry and pharmacokinetics. This
dose-escalation study utilizes a traditional 3+3 design. The
investigative sites include Honor Health in Scottsdale, Arizona and
Memorial Sloan Kettering Cancer Center in New York City. The
Company plans to report interim results from this study early in
the first quarter of 2018 and continue the dose escalation phase of
the program.
In April, the Company reported preclinical
results for MVT-1075 at the American Association of Clinical
Research (AACR) Annual Meeting,
demonstrating marked suppression, and in some instances, regression
of tumor growth in xenograft animal models of pancreatic cancer,
potentially making this product an important new therapeutic agent
in the treatment of pancreatic, colon and lung cancers. Supporting
the MVT-1075 RIT clinical investigation are the Company's
successful Phase 1a safety and target specificity data which were
reported earlier this year at the annual meetings of the American
Society for Clinical Oncology (ASCO) and the Society for Nuclear
Medicine and Molecular Imaging (SNMMI), including the clinical
results for the Company's MVT-5873
single agent therapeutic antibody
and MVT-2163,
an immuno-PET imaging agent. The combined results from 50 patients
in the Phase 1a MVT-5873 and MVT-2163 studies, established safety
and provided significant insight into drug biodistribution and an
optimal dosing strategy, which the Company has incorporated into
the MVT-1075 program.
MVT-1075 combines the clinically demonstrated tumor targeting
characteristics of the Company’s fully human HuMab-5B1
antibody and the commercially validated radionuclide, 177Lutetium,
for the purpose of delivering a lethal dose of radiation to the
targeted cancer cells.
For additional information about the Phase 1 MVT-1075 clinical
trial, please visit clinicaltrials.gov,
and reference Identifier NCT03118349.
About MVT-1075
MVT-1075 is a radioimmunotherapy product that combines established
efficacy of radiation therapy with tumor specific targeting. It has
the potential to deliver a more potent HuMab-5B1 based product.
MVT-1075 uses small doses of the Company's MVT-5873 antibody,
coupled to a radioisotope to target pancreatic cancer cells and
kill them.
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 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 dosing of the last patient in the
initial cohort of the Phase 1 clinical trial evaluating the
Company’s new human antibody-based radioimmunotherapy
(“RIT”) product MVT-1075 for the treatment of
pancreatic, colon and lung cancer 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:
+1 (908) 938-1475
Email: jtc@jenenethomascommunications.com