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| 8-K - FORM 8-K - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_apr22018.htm |
Exhibit 99.1
MabVax Therapeutics Reports 2017 Operational and Financial Results
and 2018 Milestones
– 2017 marked by clinical advancement of treatments for
various cancers -
– Management on track to execute value-driving corporate and
clinical milestones in the first half of 2018 –
– Company expects to complete one or more strategic
transactions with third parties that are intended to unlock
significant value in 2018 –
SAN DIEGO, CA (April 2, 2018) – MabVax Therapeutics
Holdings, Inc. (NASDAQ: MBVX),
a clinical-stage oncology drug
development company, announced today its financial results for the
year ended December 31, 2017.
The Company also provided an update on its corporate progress,
clinical status and anticipated milestones for Phase 1 clinical
programs including the MVT-5873 clinical trial in combination with
a standard of care chemotherapy as a first line therapy for
patients newly diagnosed with pancreatic cancer, and the MVT-1075
radioimmunotherapy clinical trial for the treatment of pancreatic,
colon and lung cancers.
Recent Highlights
●
Announced positive interim results from the
Company's ongoing Phase 1 trial evaluating MVT-5873 in
combination with standard of care chemotherapy in patients newly
diagnosed with pancreatic and other CA19-9 positive malignancies.
At the dose tested, all six patients in the cohort had meaningful
reductions in tumor volume by RECIST;
●
Reported
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 cancers;
●
Presented
preclinical data for its HuMab-Tn research program describing a new
series of fully-human antibodies targeting ovarian and breast
cancer at the AACR-NCI-EORTC International Conference on Molecular
Targets and Cancer Therapeutics;
●
Closed
$2.75 million private financing with existing shareholders;
and
●
Presented
positive research and development study results enabling
manufacturing of two radionuclide products for Phase 1 clinical
trials at the 2017 AAPS Annual Meeting.
David Hansen, MabVax's President and Chief Executive
Officer,
commented, “We are pleased with the progress we made over the
course of 2017 and we remain focused on advancing our corporate,
clinical and research strategies in 2018. We have made notable
progress with our MVT-5873 and MVT-1075 clinical programs and are
very encouraged with the positive data we have seen to date. We
look forward to continuing enrollment in each program and
participating in key scientific conferences over the course of
2018, including our upcoming presentation of new data at
AACR.”
Clinical Program Update
Clinical development of
MVT-5873 – The Company's
therapeutic product MVT-5873 is being evaluated in a Phase 1
clinical study in combination with gemcitabine and nab-paclitaxel
in first line therapy for the treatment of newly diagnosed patients
with pancreatic cancer. MabVax has treated a total of nine patients
in two cohorts since September 2017. Based on early results from
patients treated at a dose of 0.125 mg/kg in combination with
chemotherapy, the Company expanded enrollment by three additional
patients at this dose and completed enrollment and initial patient
dosing in December 2017. In February 2018, the Company reported
that all six patients treated at a dose of 0.125 mg/kg in
combination with chemotherapy had measurable tumor reductions, with
four patients meeting the criteria for partial response (PR) and
two patients meeting the criteria for stable disease (SD). Patient
CA19-9 levels, which are a prognostic indicator of the disease
state, were markedly reduced in all subjects with this combination
therapy. MVT-5873 was generally well tolerated by all subjects. The
Company is currently enrolling additional patients at this dose to
add to the statistical significance of the results seen to date and
further explore safety and potential response. For additional information about the Phase 1
MVT-5873 clinical trial, please visit clinicaltrials.gov,
and reference Identifier NCT02672917.
Clinical development of
MVT-1075 – The
Company’s development of a human antibody-based
radioimmunotherapy ("RIT") product is currently being evaluated in
a Phase 1 clinical trial for the treatment of pancreatic, colon and
lung cancer. In February 2018, MabVax announced positive interim
results from the initial cohort of the Phase 1 clinical trial
evaluating 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 has enrolled the first patient in
the second cohort at the planned 50% increase in dose. For
additional information about the Phase 1 MVT-1075 clinical trial,
please visit clinicaltrials.gov,
and reference Identifier NCT03118349.
“In addition to the advancements we have made with our
clinical programs, we continue to make progress with our efforts to
explore and evaluate strategic options through the assistance of
Greenhill & Co. As we have previously stated, we are currently
in discussions with several third parties regarding potential
partnering of certain assets for defined fields of use and expect
to close one or more strategic transactions by mid-year. At the end
of this process, we expect to retain rights to key aspects of our
antibody development program to unlock significant value for our
shareholders by advancing some of these valuable programs on our
own. We are optimistic that we will successfully conclude this
process,” added Mr. Hansen.
Expected Near-Term Milestones
●
Complete one or
more strategic transactions by mid-year with third parties
regarding potential partnering/licensing of our technologies
to unlock significant shareholder
value;
●
Complete
enrollment of additional patients and report results in the ongoing
Phase 1 trial evaluating MVT-5873 in combination with standard of
care chemotherapy in patients newly diagnosed with pancreatic and
other CA19-9 positive malignancies;
●
Report
interim progress for the second cohort in the Phase 1 clinical
trial of MVT-1075 for the treatment of pancreatic, and other CA19-9
positive malignancies; and
●
Present
three scientific posters at the American Association for Cancer
Research (AACR) Annual Meeting being held April 14-18, 2018 in
Chicago, Illinois.
Summary of Financial Results for 2017
●
Research
and development expenses for the year ended December 31, 2017 was
$7.5 million, compared to $7.8 million for the year ended December
31, 2016.
●
General
and administrative expenses for the year ended December 31, 2017
were $10.5 million, compared to $9.0 million for the year ended
December 31, 2016.
●
Net
loss for the year ended December 31, 2017 was $19.0 million,
compared to $17.7 million for the year ended December 31,
2016.
●
Cash
and cash equivalents totaled approximately $885,710 as of December
31, 2017, compared with $4.0 million as of December 31, 2016.
Management expects that current cash and cash equivalents, together
with the receipt of the $2.7 million in private placements, net of
cost of financing, in February 2018, and without any other
additional funding or receipt of payments from potential licensing
agreements, will be sufficient to fund operations through April
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, 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 is underway for our lead development program in Phase 1
clinical study of the Company's radioimmunotherapy product
MVT-1075. Our human antibody targeting Tn and sTn is in preclinical
development. For additional information, please visit the Company's
website, www.mabvax.com.
Forward Looking Statements:
This
press release on announcing the 2017 operational and financial
results contains "forward-looking statements" regarding matters
that are not historical facts, including statements relating to the
Company's ability to complete one or more strategic transactions by
mid-year with third parties regarding potential
partnering/licensing of our technologies, achievement of our
milestones in connection our clinical development programs for
MVT-5873, MVT-1075 and the immunoPET imaging agent MVT-2163, and
continuing development of the Company’s human antibody
targeting Tn and sTn in preclinical development. We have no
assurance that the near-term milestones, such as completing one or
more strategic transactions and milestones related to our product
development pipeline, will be fully achieved 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 Quarterly 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
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