SAN DIEGO, Oct. 17, 2017 /PRNewswire/ -- 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,
today provided a corporate overview and business outlook for the
remainder of 2017.
David Hansen, MabVax's President and Chief Executive Officer,
commented, "We have made significant steps forward over the course
of 2017 prioritizing our pipeline development candidates and
continuing to secure additional capital to advance our clinical
development strategy. Our technology platform continues to be
validated through our growing body of data along with our
collaborative efforts with leading institutions."
"Our focus as we move forward is to continue in two major
clinical development areas: (1) to advance the development of our
lead program, our radioimmunotherapy product MVT-1075, and (2) to
enroll additional patients in our HuMab MVT-5873 study in
combination with gemcitabine and nab-paclitaxel in first-line
therapy. We remain on track to report interim data for both studies
near the end of the year. We continue to implement strategies that
will drive value for the Company and provide the additional capital
resources necessary for continuing the development of our
potentially transformative treatment therapies for unmet needs in
cancer," Mr. Hansen added.
Clinical Programs Overview -- Making Great Strides in
Advancing Pipeline
MVT-1075 Radioimmunotherapy – In
October 2017, MabVax announced the
initiation of patient enrollment at Memorial Sloan Kettering Cancer
Center ("MSK") in New York,
representing a second site for its Phase 1 clinical trial
evaluating the Company's new human antibody-based
radioimmunotherapy ("RIT") product MVT-1075. Earlier in
June 2017 MabVax announced the
commencement of patient dosing in the Phase 1 clinical trial of
MVT-1075 at the first site, Honor Health in Scottsdale, Arizona.
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 for patients with locally advanced or
metastatic adenocarcinoma of the pancreas ("PDAC") or other CA19-9
positive malignancies including colon and lung cancers. The primary
objective is to determine the maximum tolerated dose and safety
profile in late stage patients with recurring disease who have
failed prior therapies. Secondary objectives include evaluating
tumor response rate and duration of response by RECIST 1.1, and
determining dosimetry and pharmacokinetics. This dose-escalation
study utilizes a traditional 3+3 design.
The Company intends to enroll additional patients in the Phase 1
trial to continue to assess the safety and potential efficacy of
this treatment. MabVax expects to report interim data near
year-end.
MVT-5873 Combination with Chemotherapy – Based
upon observations from the first two cohorts of patients treated,
the Company is continuing clinical development of MVT-5873 in
combination with gemcitabine and nab-paclitaxal as a first line
therapy for the treatment of patients newly diagnosed with
pancreatic cancer. MabVax has treated six patients as of
October 12, 2017 and is actively
enrolling additional patients with the objective of obtaining
additional safety and tumor response (RECIST 1.1) data.
Results From Completed Phase 1a Clinical Trials Announced
Earlier This Year
MVT-5873 as Monotherapy in Late Stage Patients - Earlier
this year the Company reported Phase 1a clinical trial results for
32 patients with advanced pancreatic cancer and other CA19-9
positive cancers treated with the therapeutic
antibody MVT-5873, and evaluated for safety and tolerability
in patients, in a poster presentation at the American Society of
Clinical Oncology ("ASCO") Annual Meeting on June 3, 2017. The Company highlighted that the
single agent MVT-5837 appears safe and well tolerated in patients
at biologically active doses and that the maximum tolerated dose
had been achieved. Furthermore, 32 patients were evaluated by
RECIST 1.1 for tumor response and 11 patients achieved stable
disease in this dose escalation safety trial.
The Company also reported results from the Phase 1a clinical
trial of MVT-2163, a PET imaging agent based on combining the
MVT-5873 antibody with 89Zr, a clinically validated
radionuclide for PET imaging, at the annual meeting of
the Society for Nuclear Medicine and Molecular Imaging
("SNMMI"). Twelve patients have been treated in this first-in-human
trial evaluating the safety and feasibility of MVT-2163 to image
pancreatic tumors and other CA19-9 positive malignancies. Uptake of
MVT-2163 was observed in primary tumors and metastases as early as
day 2 and continuously through day 7. Standard Uptake Values
("SUV"), a measurement of activity in PET imaging, were considered
very significant. The investigators reported that the high SUV are
amongst the highest lesion uptake measurements they have seen for a
radiolabeled antibody. Bone and soft tissue disease were readily
visualized and lesion uptake of the radiotracer was higher than
typically seen with PET imaging agents. The reported correlation
with Computerized Tomography ("CT") scans was also high.
The combined results from a total of 50 patients treated 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.
Corporate Development – Strategic Initiative Designed to
Unlock Significant Value
As previously announced, MabVax has engaged Greenhill & Co.
(NYSE: GHL) to serve as a financial advisor to assist the Company
in exploring and evaluating strategic options with the goal of
maximizing shareholder value. Greenhill will be assisting the
Company in evaluating transaction options currently being
considered as well as identifying new opportunities which could
include the acquisition of MabVax by another company, the sale or
divestiture of specific assets coupled with a reverse merger,
merging with another company, or licensing of selected
technologies. MabVax does not have a defined timeline for the
exploration of strategic alternatives and is not confirming that
the evaluation will result in any strategic alternative being
announced or consummated. The Company does not intend to
discuss or disclose further developments during this process unless
and until its Board of Directors has approved a specific action or
otherwise determined that further disclosure is appropriate.
Strengthened Balance Sheet – Recent Financings
Enable Continued Advancement of Lead Programs
MabVax has raised $5.2 million of
new capital over the past three months. The additional capital has
been raised in several tranches at progressively increasing share
prices as the stock of the Company has strengthened over the last
quarter. The Company plans to use this capital to fund the
enrollment of additional patients in the MVT-1075 and MVT-5873
clinical trials and maintain company operations.
"We are pleased to be able to leverage the expertise of
Greenhill in our continued efforts to identify ways to drive value
for the Company. The successful completion of our recent financings
not only demonstrates the continued support of our loyal investors,
but importantly extends our cash runway, ensures the continued
advancement of our clinical programs and enables Greenhill to
continue to implement and advance their strategic process designed
to unlock value for our shareholders," stated Gregory Hanson, Chief
Financial Officer of MabVax.
End of Year Significant Milestones
- Report interim data from the Phase 1 study evaluating MVT-1075
for the treatment of CA19-9 positive malignancies including
pancreatic, colon and lung cancers;
- Present additional data from the MVT-5873 Phase 1 program
including interim results from the administration of MVT-5873 in
combination with gemcitabine and nab-paclitaxel in first-line
therapy;
- Present new preclinical data demonstrating the use of CA19-9 as
a translational biomarker for both MVT-5873 and MVT-1075 clinical
products and the MVT-2163 immunoPET imaging agent;
- Present the initial data from the Company's HuMab-Tn antibody
preclinical program summarizing optimization of a lead candidate
for a follow-on fully human antibody development program.
Mr. Hansen concluded, "We are more encouraged than ever with the
potential of our pipeline and the promise these clinical programs
hold to provide solutions to physicians, patients and their
families battling cancer every day. We believe 2017 will continue
to be an important year of building solid clinical, regulatory,
financial and corporate foundations for our company, which should
help position MabVax for a transformational 2018."
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, 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 and 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 clinical development program, the Company's Phase 1 study of
our radioimmunotherapy product MVT-1075, with open enrollment now
at two centers. For additional information, please visit the
Company's website, www.mabvax.com.
Forward Looking Statements:
This press release on announcing the business outlook for the
Company 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
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SOURCE MabVax Therapeutics Holdings, Inc.