PLYMOUTH MEETING, Pa.,
July 16, 2019 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
that it has sharpened its corporate strategy to focus on the
commercial development of its late-stage HPV assets and reallocate
capital to develop fast-to-market product candidates. The company
has cut selected early-stage R&D programs and discontinued
further development of its Phase 1/2 study in advanced bladder
cancer, while reducing its annual burn rate by 25% and its
workforce by 28%.
Dr. J. Joseph Kim, Inovio's
President & CEO, said, "From a position of strength with a
healthy balance sheet and a 200-person team, Inovio sharpened its
focus to create a more efficient organization with greater
financial flexibility and a longer runway. With a refined strategy,
Inovio will continue to advance our later-stage HPV programs while
devoting more resources to develop fast-to-market product
candidates such as GBM, RRP and dBTEs. We continue to expect
near-term value drivers in the second half of this year that
include interim data from Phase 2 studies targeting HPV-related
vulvar and anal dysplasia and from our Phase 2 GBM study. We also
anticipate the potential for significant new partnerships as our
technology continues to attract attention from U.S. and
international markets."
Realignment enables Inovio to focus on:
- First, commercializing the lead asset VGX-3100, a novel
DNA-based immunotherapy to treat cervical dysplasia caused by human
papillomavirus (HPV), a virus that accounts for almost 200,000 new
cases of high-grade cervical dysplasia each year in the U.S. alone.
The company recently completed enrollment of its pivotal Phase 3
registration trial, REVEAL 1, and commenced enrollment for REVEAL
2.
- Second, re-deploying resources to rapidly advance INO-3107
(previously called INO-3106) to treat RRP (recurrent respiratory
papillomatosis). RRP is a rare, orphan disease caused by HPV 6 and
11 infections, for which the company recently demonstrated clinical
efficacy in a pilot study. Inovio plans to initiate the next
clinical trial of INO-3107 within 12 months.
- Third, partnership with AstraZeneca to advance MEDI0457 in
combination with AstraZeneca's checkpoint inhibitor in HPV-related
cancers, including the ongoing Phase 2 study for treatment of head
and neck cancer. AstraZeneca estimates completion of the head
and neck cancer study by next August.
- Fourth, INO-5401 development efforts on treating GBM
(glioblastoma multiforme), while discontinuing its Phase 1/2 study
of INO-5401 in advanced bladder cancer. Although the bladder trial
has yet to provide evaluable data, the decision to discontinue the
study was made because of the recognition that several new
therapeutic alternatives have been approved, or are likely to be
approved, for study patients since the trial's design and
inception, and because of the high expense of the trial. In
contrast, Inovio completed enrollment of the INO-5401 GBM study
three months ahead of schedule earlier this year, clearly
indicating unmet medical need and market potential. Inovio
continues to expect interim progression-free survival and safety
data for GBM before year-end 2019 and overall survival data in
2020. If positive clinical benefits are observed at these time
points, INO-5401 for GBM treatment could represent a fast-to-market
candidate.
- Finally, accelerating the clinical development of its
transformative dBTE (DNA-encoded bi-specific T cell engagers) which
generated potent cancer-killing activities in a preclinical study
and which build on recent advances of its innovative and high-value
dMAb™ (DNA-encoded monoclonal antibody) technology.
Inovio's important partner-funded programs are unaffected by the
realignment including: MEDI0457 in HPV-related cancers with
AstraZeneca; our Lassa and MERS vaccine programs with CEPI; the
Bill & Melinda Gates Foundation-funded Zika dMAb clinical
development program; and Inovio's commercial intra-dermal 3PSP
delivery device development funded by Medical CBRN Defense
Consortium (MCDC).
Conference Call / Webcast Information
Inovio's management will host a live conference call and webcast
on July 17th at 8:00 a.m. Eastern Time to discuss the corporate
update. The live webcast and a replay may be accessed by visiting
the Company's website at
http://ir.inovio.com/investors/events/default.aspx. Telephone
replay will be available approximately one hour after the call at
877-344-7529 (US toll free) or 412-317-0088 (international toll)
using replay access code 10133434.
About Inovio Pharmaceuticals Inc.
Inovio is an innovative clinical stage biotechnology company
focused on the discovery, development, and commercialization of its
synthetic DNA technology targeted against cancers and infectious
diseases. Inovio's proprietary technology platform applies antigen
sequencing and delivery to enable in vivo protein expression, which
can activate potent immune responses to targeted diseases. The
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
glioblastoma, as well as externally funded platform development
programs in Zika, MERS, Lassa and HIV. Partners and collaborators
include AstraZeneca, Regeneron, Roche/Genentech, ApolloBio
Corporation, GeneOne Life Science, The Bill & Melinda Gates
Foundation, Coalition for Epidemic Preparedness Innovations (CEPI),
Defense Advanced Research Projects Agency, National Institutes of
Health, National Institute of Allergy and Infectious Diseases,
National Cancer Institute, HIV Vaccines Trial Network, Walter Reed
Army Institute of Research, Medical CBRN Defense Consortium (MCDC),
The Wistar Institute, and the University of
Pennsylvania. 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-based immunotherapies, 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 immunotherapies, 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 March 31,
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:
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Investors:
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Ben Matone,
484-362-0076, ben.matone@inovio.com
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Media:
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Jeff Richardson,
267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.