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8-K - FORM 8-K - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k.htm |
Exhibit 99.1
MabVax Therapeutics Commences Patient Dosing in MVT-1075
Radioimmunotherapy Phase 1 Clinical Trial for the Treatment of
Pancreatic, Colon and Lung Cancers
Company expects to report interim results by the end of
2017
SAN DIEGO (June 27, 2017) – MabVax Therapeutics Holdings, Inc.
(Nasdaq: MBVX), a clinical-stage oncology drug development 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, today announced that the
first patient has been dosed in the Phase 1 clinical trial
evaluating MVT-1075, the Company’s fully human antibody
radioimmunotherapy (RIT), for the treatment of CA19-9 positive
malignancies including pancreatic, colon and lung
cancers.
This Phase 1 first-in-human clinical trial is an open-label,
multi-center study evaluating the safety and efficacy of MVT-1075
in up to 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
will include Honor Health in Scottsdale, Arizona and Memorial Sloan
Kettering Cancer Center in New York City.
“MabVax
is pleased to announce that we have advanced into the clinic with
the dosing of the first patient in our MVT-1075 RIT lead
development program. This significant milestone is a tribute to the
integrated collaboration of our research and development staff with
our clinical collaborators to bring this potentially life-changing
therapy to patients with pancreatic, colon and small cell lung
cancers,” said David Hansen, MabVax's President and
Chief Executive Officer. “This is the third
HuMab-5B1 based clinical trial that the Company has initiated in
the last sixteen months. We believe that the development of this
product candidate expands our pipeline to include a more potent
therapy combining the clinically demonstrated tumor targeting
characteristics of our fully human HuMab-5B1 antibody and
commercially validated 177Lutetium, to
deliver a dose of radiation to the targeted cancer cells. We look
forward to continuing enrollment, and expect to report interim
trial results by the end of 2017.”
Supporting
the MVT-1075 RIT clinical investigation are the Company’s
successful Phase 1a safety and target specificity data reported at
the annual meetings of the American Society for Clinical
Oncology (ASCO) and the Society for Nuclear Medicine and
Molecular Imaging (SNMMI) earlier this month, including the
clinical results for the Company’s HuMab-5B1 products,
MVT-5873, a single
agent therapeutic antibody and MVT-2163, an immuno-PET imaging
agent. The combined results from 50 patients in the Phase 1
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. 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.
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 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 (PDAC) and
other CA19-9 positive tumors. CA19-9 is expressed in over 90% of
PDAC and in other diseases including small cell lung and GI
cancers. CA19-9 plays a 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 PDAC. With our collaborators including
Memorial Sloan Kettering Cancer Center, Rockefeller University,
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, 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 contains "forward-looking statements" regarding
matters that are not historical facts, including statements
relating to the Company's clinical trials of MVT-1075, MVT-5873,
and MVT-2163. 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 because 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