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8-K - FORM 8-K - MABVAX THERAPEUTICS HOLDINGS, INC. | mbvx8k_june52017.htm |
Exhibit
99.1
MabVax Therapeutics Phase I Trial Results of Antibody Therapy
MVT-5873 for the Treatment of Advanced Pancreatic Cancer Presented
at the
2017 ASCO Annual Meeting
– Single Agent MVT-5873 Appears Safe and Tolerable at
Biologically Active Doses –
– One-Third of Patients with Advanced Pancreatic Cancer
Achieve Stable Disease with a Complete Response Reported
–
SAN DIEGO, California, June 5, 2017 – MabVax Therapeutics
Holdings, Inc. (Nasdaq: MBVX), 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. The Company reported results from its Phase I
clinical trial of MabVax’s therapeutic antibody MVT-5873, being
evaluated to treat patients with advanced pancreatic cancer and
other CA19-9 positive cancers 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. Further, all patients were evaluated by RECIST 1.1 for tumor
response, and the Company reported one patient achieved a complete
response and 11 more patients achieved stable disease in this dose
escalation safety trial of 32 patients.
“The
results of our Phase Ia trial with MVT-5873 indicate that we have a
fully-human antibody targeting CA19-9 cancers that can be
administered at doses with acceptable safety and with a potentially
positive impact on disease. CA19-9 is broadly expressed in various
cancers including pancreatic, colon, and small cell lung cancer
making this antibody potentially useful for a larger patient
population. The early efficacy signals from an identifiable subset
of subjects has enabled us to understand those patients most likely
to respond to MVT-5873 based therapy. At the maximum tolerated dose
(MTD) we have established in this trial, we have demonstrated an
acceptable safety margin and have cleared the way for MVT-5873 in
combination with our immunoPET imaging agent (MVT-2163) and
Radioimmunotherapy (MVT-1075) which are currently in phase I
clinical trials,” said David Hansen, President and CEO of
MabVax.
The
recently completed Phase Ia trial was an open-label,
dose-escalation study evaluating the safety, tolerability and
pharmacokinetics of MVT-5873 as a single-agent in patients with
locally advanced or metastatic pancreatic or colon cancer who had
failed all prior therapies and regressed into progressive disease.
Secondary endpoints included evaluation of tumor response by RECIST
1.1 and duration of response. A second arm of the Company’s
MVT-5873 Phase Ia trial is actively evaluating MVT-5873 in
combination with gemcitabine plus nab-paclitaxel in newly diagnosed
pancreatic cancer patients. Dr. Eileen O’Reilly, Associate
Director of the David M. Rubenstein Center for Pancreatic Cancer
Research, attending physician, member at Memorial Sloan Kettering
Cancer Center and Professor of Medicine at Weill Cornell Medical
College is the lead investigator in the MVT-5873 Phase I clinical
trial.
Safe and Tolerable Dose Established
MVT-5873
was administered in both weekly and every other week dosing
schedules. A maximum tolerated dose (MTD) was determined at 1 mg/kg
with both dosing schedules. Dose limiting toxicities (DLTs) with
single-agent MVT-5873 were reversible increases in liver function
tests, that occurred early in Cycle 1 of therapy and typically
resolved within a week. Most patients experiencing DLT events were
able to continue therapy at a reduced dose. Infusion reactions were
mitigated with the use of premedication and extended infusion
times. To date, there has been no evidence that MVT-5873 induces
antibody-drug-antibodies (ADA) in treated patients.
Potential Efficacy Signal Observed in Patients
The
levels of serum tumor marker CA19-9 are considered a valuable
adjunct in the diagnosis, prognosis and monitoring of treatment of
pancreatic cancer. Treatment with MVT-5873 normally results in a
decrease in the serum tumor marker CA19-9 levels immediately
following administration. After completing the first treatment
Cycle, lasting 28 days, forty percent of patients had a sustained
decrease in CA19-9 levels of greater than or equal to 50%. Patients
with a greater than or equal to 50% reduction in CA19-9 levels
continued treatment for a median of four cycles (range 2 to 9.75+),
compared to one cycle (range 0.25 to 3) for patients with less than
50% decrease. Twelve of thirty-two patients achieved a stable
disease (SD) response as determined by RECIST 1.1 measurements made
every second cycle of therapy. One patient achieved a complete
response (CR) by the first RECIST 1.1 time point at the end of the
second cycle.
“Combining
the results from our MVT-5873 single agent trial and our MVT-2163
immunoPET trial, whose Phase 1a results will be announced at the
Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual
meeting held June 10-14, 2017, gives us an opportunity to enrich
patient selection for our upcoming clinical trials. We think there
is a place for MVT-5873 in the treatment of CA19-9 expressing
cancers including in combination with a standard of care
chemotherapy for newly diagnosed treatment naïve patients.
MVT-5873 is being evaluated in combination with gemcitabine and
nab-paclitaxel in a second arm of this Phase I trial and we
anticipate results to be available later this year. We continue to
be focused on bringing more potent MVT-5873-based products into the
clinic. The first of these more potent products is our
radioimmunotherapy agent MVT-1075 for which we plan to initiate the
Phase I trial this month,” continued Mr. Hansen.
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 lead
antibody is directed at an antigen target expressed on more than
90% of pancreatic cancers and a significant amount of other GI and
lung cancers, making the antibody potentially broadly applicable to
a wide variety of patients suffering from difficult to treat
cancers. With our collaborators including Memorial Sloan Kettering
Cancer Center, Rockefeller University, Sarah Cannon, 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 I clinical
studies, and demonstrated early safety, specificity for the target
and an early efficacy signal. Results of these trials should be
published by mid-year 2017. Additionally, our Phase I clinical
study of our radioimmunotherapy product designated as MVT-1075 has
commenced with patient enrollment. 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 presentations at the ASCO Annual Meeting. 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
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: +1 (908) 938-1475
Email: jtc@jenenethomascommunications.com