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| 8-K - CURRENT REPORT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_feb282018.htm |
Exhibit
99.1
MabVax Therapeutics Reports Positive Safety Results from Initial
Cohort of MVT-1075 Radioimmunotherapy Phase 1 Trial for the
Treatment of Pancreatic, Colon and Lung Cancers
– Safety results in first cohort enable patient enrollment in
second cohort at increased dose –
– Tumor target specificity and accumulation of radiolabeled
antibody demonstrated in first cohort of treated patients
–
SAN DIEGO, February 28, 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 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.
Results from the first three patients dosed in the initial cohort
of this dose escalation Phase 1 safety trial demonstrated that
MVT-1075 is reasonably well tolerated and accumulates on tumor as
evidenced by dosimetry measurements performed after the first dose.
At this initial dose, two subjects met the criteria for stable
disease (SD) and one met the criteria of progressive disease (PD)
as measured using RECIST 1.1 criteria. Hematologic toxicities were
manageable, and the Company is enrolling the first patient in the second
cohort.
“We achieved our primary objectives in this early-stage
clinical trial of our novel radioimmunotherapy product MVT-1075. We
were able to establish safety at the first dose and generated our
first clinical data with this product confirming targeting
specificity and accumulation of the radiolabeled antibody on target
lesions over time. The toxicities that emerged were expected and
manageable. Having established safety at this first low dose level,
we are now enrolling patients at the next planned dose and are
optimistic that we will see impacts on tumor as we continue this
study,” commented David Hansen, MabVax's
President and Chief Executive Officer.
This Phase 1 first-in-human clinical trial is an open-label,
multi-center study evaluating the safety and efficacy of MVT-1075
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 were 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.
“We continue to believe that combining the
clinically-demonstrated tumor targeting characteristics of our
fully human HuMab-5B1 antibody and the commercially validated
radionuclide, 177Lutetium,
we can deliver a lethal dose of radiation to the targeted cancer
cells,” added Mr. Hansen.
The Company previously reported preclinical results for MVT-1075 at
the 2017 Annual Meeting of the American Association of Clinical
Research (AACR), 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 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.
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 results
from the enrollment and dosing of 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 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: MBVX@jtcir.com
Media Contact:
Travis Kruse, Ph.D.
Russo Partners LLC
Phone: 212-845-4272
Email: travis.kruse@russopartnersllc.com