Attached files
file | filename |
---|---|
8-K - PRIMARY DOCUMENT - MABVAX THERAPEUTICS HOLDINGS, INC. | mdvx8k_nov142016.htm |
Exhibit
99.1
MabVax Therapeutics Reports Interim Safety and Imaging Results from
Phase I Clinical Trials in HuMab-5B1 Antibody Development
Programs
Sufficient safety established to initiate the evaluation of
MVT-5873 as a front-line therapy in combination with a standard of
care chemotherapy
Safety and proof of concept demonstrated for tumor visualization
with MVT-2163. Advancing to optimize image in pancreatic cancer
patients.
SAN
DIEGO, CA – November 14, 2016 – MabVax Therapeutics
Holdings, Inc. (NASDAQ: MBVX), a
clinical stage immuno-oncology drug development
company, reported on progress from its two HuMab-5B1 antibody phase I programs
evaluating the use of MVT-5873 as a therapeutic antibody and
MVT-2163 as an immuno-PET imaging agent in patients with locally
advanced and metastatic pancreatic cancer or other CA19-9 positive
malignancies.
MVT-5873
Interim Phase I Data in Pancreatic Cancer
The
MVT-5873 phase I clinical trial initiated in February 2016 is
designed to establish safety and determine the recommended phase II
dose (RP2D) for MVT-5873 as both as monotherapy (Part 1 of the
trial), and in combination with standard of care chemotherapy (Part
2) using nab-paclitaxel plus gemcitabine. Initiation of Part 2
requires establishing three safe dose levels for MVT-5873 as
monotherapy in patients with relapsed or refractory locally
advanced or metastatic pancreatic cancer. The Company reports that
the safety of MVT-5873 has been established at three incremental
dose levels by treating 16 patients at three clinical sites. While
patients continue to be recruited to establish the RP2D, the
Company also reports that Part 2 of the clinical trial is now open
and will include patients with previously untreated pancreatic
cancer receiving a standard of care chemotherapy as defined in the
protocol.
To
date, the study has consented 28 subjects with 3 in screening, 9
screen failures, and 16 subjects treated. Of the 16 patients
treated, six continue to receive treatment. Patients can remain on
therapy based on dose tolerability and investigator assessment of
continued benefit including assessment of disease status using
RECIST 1.1 criteria to evaluate tumor response rate and duration of
response. Stable disease was noted for seven patients lasting from
three months to eight months. The dosage safety levels established
in Part 1 of the trial also support the dosage levels of MVT-5873
to be used in conjunction with the company’s MVT-2163
immuno-PET imaging agent and the MVT-1075 radioimmunotherapy
product which is planned to begin phase I clinical evaluation early
in 2017.
MVT-2163
Interim Phase I Data in Pancreatic Cancer
The
MVT-2163 phase I trial was initiated in June of this year to
evaluate the company’s next
generation diagnostic PET imaging agent in patients with
locally advanced or metastatic adenocarcinoma of the pancreas
(PDAC) or other CA19-9 positive malignancies. MVT-2163
(89Zr-HuMab-5B1)
combines the well-established PET imaging radiolabel Zirconium
[89Zr]
with the targeting specificity of MVT-5873. This trial is designed
to establish safety, pharmacokinetics, biodistribution, and the
amount of MVT-5873 to be used in co-administration to obtain
optimized PET scan images. The company has demonstrated interim
safety, pharmacokinetics, and biodistribution by completing the
initial two cohorts of patients: the first cohort administered
MVT-2163 alone and the second cohort administered MVT-2163
following a blocking dose of MVT-5873. The company reports
that the initial PET images demonstrated target specificity by
correlation with lesions identified by conventional computerized
tomography (CT) scans. The biodistribution data obtained in the
first two cohorts demonstrates improvement in PET images by
pre-administration of MVT-5873, as has been observed with other
antibody based PET agents. The company is actively recruiting
patients and expects to establish the optimal co-administration
dose of MVT-5873 early in 2017.
“Our strategy
at the outset was to initiate these two clinical trials
concurrently to address the key questions of safety and targeting
specificity for the HuMab-5B1 antibody. We are highly encouraged by
these promising early results from the MVT-5873 and MVT-2163
clinical trials,” stated President and CEO J. David Hansen.
He added, “We are moving ahead with the planned combination
of MVT-5873 with a standard of care chemotherapy in a
chemotherapy-naïve pancreatic cancer patient population and
are looking forward to presenting these results next year. We are
continuing to accrue patients in order to establish the RP2D for
MVT-5873 as a monotherapy. In the MVT-2163 trial, dose escalation
continues to confirm optimal dose and
timing for the best PET scan image. Finally, the company
remains on track for submitting the Investigational New Drug
Application (IND) for MVT-1075 to the Food And Drug Administration
(FDA) later this year, and plans to initiate the phase I trial of
MVT-1075 in the first half of 2017 after receiving FDA
authorization to proceed.”
About
MabVax
MabVax
Therapeutics Holdings, Inc. is a clinical-stage biotechnology
company focused on the development of antibody-based products to
address unmet medical needs in the treatment of cancer.
MabVax has discovered a pipeline of human monoclonal antibody
products based on the protective immune responses generated by
patients who have been vaccinated against targeted cancers with the
Company's proprietary vaccines. MabVax's HuMab-5B1 antibody
is fully human and was discovered from the immune response of
cancer patients vaccinated with an antigen-specific vaccine during
a Phase I trial at Memorial Sloan Kettering Cancer
Center. The antigen the antibody targets is expressed
on more than 90% of pancreatic cancers, making the antibody
potentially broadly applicable to most patients suffering from this
type of cancer. Additional information is available at
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 progress in its two
phase I clinical trials of MVT-5873 and MVT-2163, and plans for
2017. We have no assurance that all of 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,
2015, and the Company's Quarterly Reports on Form 10-Q, as
such filings may be amended and supplemented from time to time, and
other filings and reports by the Company with 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:
Robert
Haag
Managing
Director
IRTH
Communications
MBVX@irthcommunications.com
1-866-976-4784