Country for PR: United States
Contributor: PR Newswire New York
Tuesday, January 07 2020 - 00:00
AsiaNet
Inovio Provides Update on Clinical Program Plans for 2020
PLYMOUTH MEETING, Pennsylvania., Jan. 6, 2020 /PRNewswire-AsiaNet/ --

  -- Inovio to present 2020 program plans at Biotech Showcase 2020 Conference 

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: 	Tuesday, January 14, 2020
  Time: 	10:30am (PST)
  Track: 	Yosemite A (Ballroom Level)
  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

SOURCE: Inovio Pharmaceuticals, Inc.
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