PLYMOUTH MEETING, Pa.,
Jan. 6, 2020 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NASDAQ:INO) announced that Inovio's
President & CEO, Dr. J. Joseph
Kim will present a corporate update of the company's
clinical program goals for 2020 at the Biotech Showcase 2020
Conference in San Francisco,
CA.
Biotech Showcase
2020 Conference Presentation Details:
|
|
Date:
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Tuesday, January 14,
2020
|
Time:
|
10:30am
(PST)
|
Track:
|
Yosemite A (Ballroom
Level)
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Venue:
|
Hilton San Francisco
Union Square Hotel, 333 O'Farrell Street, San Francisco,
CA
|
The presentation will be webcast live and may be accessed by
visiting Inovio's website at
http://ir.inovio.com/investors/events/default.aspx. Archived
versions of the presentations will be made available through the
Inovio Investor Relations Events
page.
Inovio anticipates for 2020 to be a transformative year for the
company. At the Biotech Showcase 2020 presentation, Dr. Kim will
highlight multiple value-driving catalysts, clinical development,
and program readouts which are all expected this year.
VGX-3100/INO-3107: HPV-Related Diseases
- VGX-3100. Inovio expects to report VGX-3100 REVEAL 1 top-line
efficacy data in the fourth quarter of 2020. Through extensive work
on amending the clinical readout timing a year earlier than
originally designed, these early top-line data will be made
available without compromising the integrity of both REVEAL 1 and
REVEAL 2 trials. If positive, Phase 3 top-line data could provide
further regulatory validation for this first-in-class DNA Medicine
for treating cervical dysplasia.
- INO-3107. Inovio continues to expand its DNA Medicine franchise
to treat HPV-related diseases by advancing INO-3107 to treat RRP,
an orphan disease indication with a potential accelerated
regulatory pathway.
- In the first half of this year, Inovio plans to initiate a
Phase 2 clinical trial of INO-3107 for RRP, which impacts both
pediatric and adult patients. RRP is caused by HPV 6 and 11
infections, which form non-cancerous tumors in the airways of
patients who suffer from this disease. Currently, the disease is
incurable and can only be treated by frequent surgeries to remove
the tumors, which temporarily restores the airway before renewed
tumor growth.
- In a previous pilot study, two adult patients with RRP had
required surgery approximately every six months to clear tumor
growth from their throats. Since their last dose of Inovio's HPV
product candidate, both patients have been able to avoid or
significantly delay surgery. One patient has not needed surgery for
almost three years as of the last follow-up. The other patient did
not require surgical intervention for approximately one and a half
years, a significant delay in surgery intervals prior to the trial
enrollment.
- Inovio believes INO-3107 could provide a novel treatment option
for patients and a significant commercial opportunity for Inovio.
Inovio is fully committed to bringing this product candidate to the
market as soon as possible using all of the regulatory and
development pathways available for rare, orphan diseases.
Dr. J. Joseph Kim, Inovio's
President & CEO said, "In July, Inovio management took the
difficult but necessary step to streamline expenses and prioritize
our pipeline candidates. We have also accelerated important REVEAL
1 top-line data readout to the fourth quarter of 2020, allowing the
market and potential global partners to see this data sooner than
expected and moved to rapidly advance INO-3107, an orphan eligible
and fast-to-market product candidate.
"Looking ahead, the coming year sets up to be a transformational
period for Inovio, with top-line efficacy data from our REVEAL 1
Phase 3 trial, in addition to INO-5401 Glioblastoma overall
survival data at months 12 and 18 and expected MEDI0457 head and
neck cancer results from AstraZeneca. These upcoming trial results
in 2020 will be important drivers for the achievement of Inovio's
long-term strategy and maximizing the commercial potential of our
DNA Medicine pipeline."
INO-5401/Glioblastoma Multiforme (GBM) Phase 2 Trial
- INO-5401. Inovio will report 12- and 18-month overall survival
data in 2020. Last year, Inovio reported promising progression-free
survival at six months from its ongoing Phase 2 trial of newly
diagnosed glioblastoma multiforme (GBM), which combines Inovio's
product candidates INO-5401, a T cell-activating immunotherapy
encoding for three tumor-specific antigens (hTERT, WT1, and PSMA),
and INO-9012, an immune activator, in combination with
Libtayo®, a PD-1 blocking antibody produced by Regeneron
Pharmaceuticals in collaboration with Sanofi.
Key interim data from the
52-patient clinical trial showed that 80% (16 of 20) of MGMT gene
promoter methylated patients and 75% (24 of 32) of unmethylated
patients were progression-free at six months measured from the time
of their first dose, significantly exceeding historical
standard-of-care data. The majority of patients tested had a T cell
immune response to one or more tumor-associated antigens encoded by
INO-5401. Immune responses to all three tumor-associated antigens
were demonstrated in this trial. The interim data were presented at
the Society for Immunotherapy of Cancer (SITC) 2019 Annual
Meeting.
INO-5151/Prostate Cancer Combination Trial
- INO-5151. Parker Institute-funded cancer combination trial
using INO-5151 in metastatic castration-resistant prostate cancer
patients is currently enrolling. INO-5151 is a formulation that
combines INO-5150 (with antigens encoding for PSA and PSMA) with
INO-9012 (a T-cell activator). INO-5151 is being tested in one arm
(Cohort C) of this immunotherapy combination study along with
nivolumab, a PD-1 inhibitor (Bristol-Myers Squibb), and CDX-301
(Celldex Therapeutics).
Infectious Diseases/New Product Development
Candidates
- INO-4500. In 2020, Inovio will present Phase 1, first-in-human
clinical trial evaluating INO-4500, its candidate vaccine to
prevent infection from the Lassa virus. This Inovio trial conducted
in the U. S. represents the first Lassa candidate vaccine to enter
the clinic. This Inovio-sponsored trial, as well as its INO-4500
program, is fully funded through a global partnership with CEPI –
the Coalition for Epidemic Preparedness Innovations. Inovio is also
planning to advance INO-4500 to a Phase 1b trial in Africa in 2020.
- INO-4700. In 2020, Inovio expects to advance INO-4700, its
candidate vaccine against MERS (Middle East Respiratory Syndrome),
into a Phase 2 field study in the Middle
East and Africa where
outbreaks have been observed, with full funding from CEPI. This is
the most advanced vaccine candidate for MERS.
- INO-A002. Inovio expects to report results in 2020 from its
first-in-human trial of dMAb candidate INO-A002 (for preventing or
treating Zika virus infection) from a Phase 1 dose-escalation trial
to assess safety and tolerability and expression of dMAb-produced
antibodies with full funding from the Bill & Melinda Gates
Foundation. Using direct local delivery into the body, the
synthetic genetic codes provided by the dMAb plasmids instruct the
body's cells to become a customized patient-specific factory that
manufactures its own therapeutic monoclonal antibodies, enabling a
major leap in antibody technology. With its plasmid design and
in-patient production, dMAb products represent a disruptive and
innovative entrant to this important class of pharmaceuticals.
About Inovio
Inovio is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat, cure and/or
protect people from diseases associated with HPV, cancer, and
infectious diseases. Inovio is the first and only company to have
clinically demonstrated that a DNA medicine can be delivered
directly into cells in the body via a proprietary smart device to
safely produce a robust immune response to destroy and clear
high-risk HPV 16 and 18, which are responsible for 70% of cervical
cancer, 90% of anal cancer and 69% of vulvar cancer. In addition to
HPV, Inovio's optimized plasmid design and delivery technology has
been demonstrated to consistently activate robust and fully
functional T cell and antibody responses against targeted cancers
and pathogens. Inovio's most advanced clinical program, VGX-3100,
is in Phase 3 development for the treatment of HPV-related cervical
pre-cancer. Also in development are Phase 2 immuno-oncology
programs targeting HPV-related cancers and GBM, as well as
externally funded platform development programs in Zika, MERS,
Lassa, and HIV. Partners and collaborators include ApolloBio
Corporation, AstraZeneca, The Bill & Melinda Gates Foundation,
Coalition for Epidemic Preparedness Innovations (CEPI), Defense
Advanced Research Projects Agency, GeneOne Life Science, HIV
Vaccines Trial Network, Medical CBRN Defense Consortium (MCDC),
National Cancer Institute, National Institutes of Health, National
Institute of Allergy and Infectious Diseases, Regeneron,
Roche/Genentech, University of
Pennsylvania, Walter Reed Army Institute of Research, and
The Wistar Institute. For more information, visit
www.inovio.com.
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
DNA medicines, our expectations regarding our research and
development programs, as well as commercialization activities,
including the planned initiation and conduct of clinical trials,
the availability and timing of data from those trials and our
commercialization strategy and tactics. 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, product development programs and
commercialization activities and outcomes, 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, 2018, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2019, and other filings we make from time to time with the
Securities and Exchange Commission. 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 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, 484-362-0076,
ben.matone@inovio.com
Media:
Jeff Richardson, 267-440-4211,
jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.