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8-K - CURRENT REPORT - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_jan162018.htm |
Exhibit 99.1
MabVax Therapeutics Holdings, Inc. Provides Business Strategy
Update
– Company makes solid progress in advancing discussions with
multiple third parties in the evaluation of strategic options that
are expected to unlock significant value –
– Management on track to execute value-driving corporate and
clinical milestones in the first half of 2018 –
SAN DIEGO, January 16, 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, today provided an update on its business
strategy initiatives.
In
September 2017, MabVax announced its engagement with Greenhill
& Co. (NYSE: GHL) to serve as an advisor to assist the Company
in exploring and evaluating strategic options with the goal of
maximizing stockholder value. With the assistance of Greenhill,
MabVax is currently in advanced discussions with a variety of
interested parties for potential multiple transaction proposals as
well as continuing to identify new opportunities.
In
parallel with the strategic initiatives efforts led by Greenhill
& Co., MabVax continues to advance its Phase 1 clinical
programs including the MVT-1075
radioimmunotherapy clinical trial for the treatment of pancreatic,
colon and lung cancers, and 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. In addition, the Company’s lead research
program, HuMab-Tn, has generated significant interest and continues
as part of its discussions with external parties.
David Hansen, MabVax's President and Chief Executive
Officer, commented, “Over the course of 2017, our
management team has been highly focused on advancing our corporate,
clinical and research strategies, and I am pleased to report that
we have made great strides on all fronts. Our engagement with
Greenhill, whose sole mandate has been to provide MabVax with
opportunities in exploring and evaluating strategic options, is
progressing extremely well. We are now in advanced discussions with
several third parties regarding potential partnering of certain
antibody assets for defined fields of use. At the end of this
process, MabVax expects to retain rights to key aspects of our
antibody development program to build value for our shareholders by
advancing on our own some of these assets. We are very optimistic
that we will successfully conclude this process early this
year.”
“Further, following our pipeline review and prioritization
process last year, we identified our lead development programs and
have focused all of our resources on advancing MVT-1075 and
MVT-5873 in a meaningful way throughout the year. We are on track
to report interim data from both Phase 1 studies before the end of
the first quarter of this year. Our goal has been to propel MabVax
to its next stage of growth and unlock significant value for our
shareholders. I believe we are well prepared to achieve this and
have positioned MabVax for a transformational year,” added
Mr. Hansen.
The Company’s lead product candidate, MVT-1075, 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 December 2017,
the Company announced completion of
enrollment and dosing of all patients in the initial cohort of the
Phase 1 trial. MabVax plans to
continue its clinical development of MVT-1075 by completing
additional cohorts of patients in a dose escalation safety trial to
continue to assess the safety and response data for this treatment,
and remains on track to report results in the first quarter of
2018.
Clinical
development of MVT-5873, the Company’s therapeutic product
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,
remains ongoing. MabVax has treated a total of nine patients in two
cohorts since September. The Company initiated an additional
expanded cohort of the Phase 1 trial evaluating MVT-5873 in
combination with standard of care chemotherapy and announced the completion of
enrollment and initial patient dosing in that expanded
cohort in December 2017. The Company remains on track to announce interim
safety and response data in the first quarter of
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 over 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. Our HuMab-Tn program is our
most advanced research program and expands the potential to provide
treatment for unmet therapeutic need for the treatment of ovarian
and triple negative breast cancers. 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 and research programs including our HuMab-Tn program.
We have no assurance that all the research and 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
Media Contact
Travis
Kruse, Ph.D.
Russo
Partners LLC
Phone:
212-845-4272
Email:
travis.kruse@russopartnersllc.com