PLYMOUTH MEETING, Pa.,
Jan. 24, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) today announced
that a second patient with HPV-related head and neck cancer treated
with INO-3112 (now called MEDI0457) in a Phase 1 trial achieved a
sustained complete response (full remission) after subsequent
treatment with a PD-1 checkpoint inhibitor. This marks the second
patient with metastatic cancer observed in full remission
(complete response) after treatment with synthetic DNA vaccine
followed by a PD-1 checkpoint inhibitor.
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Dr. J. Joseph Kim, Inovio's
President and CEO, said, "Achieving sustained complete responses
with immunotherapy in metastatic cancer patients is what you hope
for with novel cancer treatments. The fact that the treatment with
our synthetic DNA vaccine followed with two different PD-1
inhibitors in this HPV-related cancer patient population showed a
complete response in 2 out of 4 progressors is very encouraging as
the best complete response rate by PD-1 inhibitors as a monotherapy
in metastatic head and neck cancer is approximately 4%. While
additional data from Phase 2 clinical studies will provide more
insights to the power of synthetic DNA vaccine, this newly reported
data provides additional validation for Inovio's overall cancer
combination strategy using a T cell activator combined with a
checkpoint inhibitor against an array of cancers with big pharma
partners providing various checkpoint inhibitors. In addition to
our partnership around HPV-related cancers, Inovio is also
collaborating with F. Hoffman-La Roche Ltd./Genentech and Regeneron
in efficacy trials coupling Inovio's INO-5401 with their checkpoint
inhibitors designed to increase response rates in metastatic
bladder and GBM, respectively, with interim efficacy data expected
later this year."
Both patients who achieved full cancer remission were treated
with four doses of synthetic DNA vaccine as part of a Phase 1
monotherapy trial of 22 patients with HPV-related head and neck
squamous cell carcinoma in which 91% of patients (20/22) showed T
cell activity in the blood or tissue. This demonstrates that
synthetic DNA vaccine generated robust HPV16/18 specific CD8+ T
cell responses in peripheral blood and increased CD8+ T cell
infiltration in resected tumor tissue samples.
Of the four patients who developed progressive disease and were
subsequently administered a PD-1 checkpoint inhibitor, two patients
rapidly exhibited a complete response. The most recent patient for
which data was presented yesterday received pembrolizumab
(KEYTRUDA®); while the previously reported complete
responder was treated with nivolumab (OPDIVO®). The
patients moved from metastatic head and neck cancer to no evidence
of disease and they remain alive two years after treatment.
Detailed results of the first patient with head and neck cancer who
received nivolumab were published in the October issue of
Clinical Cancer Research.
These results were presented on January
23 at the Keystone Symposia Conference/Cancer Vaccines being
held in Vancouver, Canada by Dr.
David B. Weiner, Executive Vice
President of The Wistar Institute, Director of its Vaccine Center,
and the W. W. Smith Charitable Trust Endowed Professorship in
Cancer Research.
KEYTRUDA® is a registered trademark of Merck & Co. (MRK);
OPDIVO® is a registered trademark of Bristol-Myers Squibb Company
(BMY).
About HPV-Related Head & Neck Cancer
Human papillomavirus (HPV) is the most common sexually
transmitted disease in the United
States, currently infecting about 79 million Americans. HPV
is known to play a major role in the development of head and neck
cancers, which include cancers of the oral cavity, oropharynx,
nose/nasal passages and larynx. In 2019 an estimated 53,000 persons
will get oral cavity or oropharyngeal cancer in the U.S. New cases
of head and neck cancer occur nearly three times more often in men
as in women. Incidence rates of head and neck cancers have been on
the rise, especially HPV-related oropharyngeal cancer in men, and
are expected to continue growing.
About Inovio Pharmaceuticals, Inc.
Inovio is a late-stage biotechnology company focused on the
discovery, development, and commercialization of DNA
immunotherapies that transform the treatment of cancer and
infectious diseases. Inovio's proprietary platform technology
applies next-generation antigen sequencing and DNA delivery to
activate potent immune responses to targeted diseases. The
technology functions exclusively in vivo, and has been demonstrated
to consistently activate robust and fully functional T cell and
antibody responses against targeted cancers and pathogens. Inovio
is the only immunotherapy company that has reported generating T
cells whose killing capacity correlates with relevant clinical
outcomes. Inovio's most advanced clinical program, VGX-3100, is in
Phase 3 for the treatment of HPV-related cervical pre-cancer. Also
in development are Phase 2 immuno-oncology programs targeting head
and neck cancer, bladder cancer, and glioblastoma, as well as
platform development programs in hepatitis B, Zika, Ebola, MERS,
and HIV. Partners and collaborators include MedImmune, Regeneron,
Roche/Genentech, ApolloBio Corporation, The Bill and Melinda Gates
Foundation, The Wistar Institute, the University of Pennsylvania, Parker Institute for
Cancer Immunotherapy, CEPI, DARPA, GeneOne Life Science, Plumbline
Life Sciences, Drexel University, NIH,
HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval
University. For more information, visit www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
electroporation-based drug and gene delivery technologies and DNA
vaccines, our expectations regarding our research and development
programs, including the planned initiation and conduct of clinical
trials and the availability and timing of data from those
trials. Actual events or results may differ from the
expectations set forth herein as a result of a number of factors,
including uncertainties inherent in pre-clinical studies, clinical
trials and product development programs, the availability of
funding to support continuing research and studies in an effort to
prove safety and efficacy of electroporation technology as a
delivery mechanism or develop viable DNA vaccines, our ability to
support our pipeline of SynCon® active immunotherapy and vaccine
products, the ability of our collaborators to attain development
and commercial milestones for products we license and product sales
that will enable us to receive future payments and royalties, the
adequacy of our capital resources, the availability or potential
availability of alternative therapies or treatments for the
conditions targeted by us or our collaborators, including
alternatives that may be more efficacious or cost effective than
any therapy or treatment that we and our collaborators hope to
develop, issues involving product liability, issues involving
patents and whether they or licenses to them will provide us with
meaningful protection from others using the covered technologies,
whether such proprietary rights are enforceable or defensible or
infringe or allegedly infringe on rights of others or can withstand
claims of invalidity and whether we can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
our technology by potential corporate or other partners or
collaborators, capital market conditions, the impact of government
healthcare proposals and other factors set forth in our Annual
Report on Form 10-K for the year ended December 31, 2017, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2018 and other regulatory filings we make from time to
time. There can be no assurance that any product candidate in
our pipeline will be successfully developed, manufactured or
commercialized, that final results of clinical trials will be
supportive of regulatory approvals required to market licensed
products, or that any of the forward-looking information provided
herein will be proven accurate. Forward-looking statements
speak only as of the date of this release, and we undertake no
obligation to update or revise these statements, except as may be
required by law.
CONTACTS:
Investors:
Ben Matone, Inovio, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson,
Inovio, 267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.