PLYMOUTH MEETING, Pa.,
Dec. 9, 2020 /PRNewswire/
-- INOVIO (NASDAQ:INO), a biotechnology company focused on
bringing to market precisely designed DNA medicines to treat and
protect people from infectious diseases, cancer and diseases
associated with HPV, today announced positive Phase 2 efficacy
results demonstrating that DNA medicine VGX-3100, the company's
lead immunotherapy asset, showed resolution of HPV-16/18-associated
precancerous anal lesions (HSIL) in 50% (11 of 22) of subjects six
months following the start of treatment. The open label, single arm
trial also showed VGX-3100 to be safe and well-tolerated in
treating men and women with HPV-16-/18-associated anal dysplasia.
INOVIO plans to pursue a registrational Phase 3 clinical trial for
HPV-16-/18-associated anal dysplasia as well as to apply for rare
and orphan disease designation for this indication in 2021.
Dr. Céline Bouchard, Gynecologist and Anoscopist at Centre
Médical Santé Femme in Québec City, Canada and Coordinating Principal Investigator
for the Phase 2 trial, said, "Results of this trial are very
promising and may offer a safe and efficacious new therapeutic
option for patients suffering from this debilitating
condition."
VGX-3100 Phase 2 Anal Dysplasia Trial Highlights
- Enrolled 23 men and women 18 years of age or older. One subject
discontinuation occurred due to an event related to a pre-existing
condition of depression.
- Trial participants were men and women between 29 and 76 years
of age at entry and other than having high grade anal squamous
intraepithelial lesions were otherwise healthy.
- The relative proportion of anal dysplasia severity at baseline
was skewed toward the more severe condition of AIN-3 disease (78%
[18/23] of subjects). Subjects had a median of 4 lesions (range
2-7).
- Results are based on the demonstration of having no evidence of
dysplasia from anal biopsy samples as assessed by two independent
pathologists and non-detectability of HPV-16 or HPV-18 from lesion
tissue using PCR-based testing, at six months following VGX-3100
administration.
- Efficacy endpoints were measured six months post-treatment.
Safety will continue to be assessed for 18 months following the
last dose.
- The most observed adverse event was injection site pain, the
majority of which were mild to moderate.
- No discontinuations occurred due to treatment-related adverse
events
- No treatment-emergent serious adverse events have been
observed.
- No cases of anal cancer have been observed in the trial.
For more information about the Phase 2 trial, please visit
www.clinicaltrials.gov (search identifier NCT03499795).
Prakash Bhuyan, M.D., Ph.D.,
Senior Vice President and Head of HPV Therapeutic Clinical
Development at INOVIO, said, "Anal dysplasia is a rare disease that
is typically treated via surgical excision, electro-cautery or
laser therapy, with up to 50% of patients experiencing disease
recurrence within one year of surgical treatment. We are encouraged
by these positive results from our Phase 2 trial and look forward
to continuing our work in Phase 3 trials to develop a systemic
DNA-based immunotherapy that leverages our DNA medicines platform
in order to improve the current standard of care."
INOVIO also has an ongoing partnership with the AIDS
Malignancy Consortium (AMC) to evaluate VGX-3100 in HIV-positive
adult men and women. This ongoing open-label, multi-center Phase 2
study is designed to evaluate the safety and efficacy of VGX-3100
administered by intramuscular (IM) injection with CELLECTRA®
delivery system in adult men and women who are HIV-positive with
anal HSIL associated with HPV-16 and/or HPV-18. For additional
information about the AMC-partnered study, please visit
www.clinicaltrials.gov (search identifier NCT03603808).
About Anal Dysplasia
Anal dysplasia is a rare disease that affects men and women in
both immunocompetent and immunocompromised populations. Fewer than
1 in 5 people with HPV-16- or HPV-18-associated precancerous
dysplasia exhibit spontaneous resolution at one year. Without
adequate treatment, anal dysplasia can progress to anal cancer.
HPV-16/18 cause more than 90% of all anal cancer, which is now
considered one the most rapidly rising causes of cancer incidence
and mortality. According to the American Cancer Society, anal
cancer will claim the lives of more than 1,300 people in the U.S.
and 8,590 news cases (5,900 in women and 2,690 in men) will be
diagnosed in 2020. According to a study published November 2019 in the Journal of the National
Cancer Institute, from 2001 to 2015 the overall incidence of anal
cancer increased by 2.7% per year and mortality jumped by 3.1% each
year.
About VGX-3100
VGX-3100 is a DNA medicine in clinical trials for the treatment
of three HPV-16/18 related disease states – anal dysplasia, vulvar
dysplasia and cervical dysplasia. The cervical dysplasia program is
in late Phase 3 clinical trials (REVEAL1 and REVEAL2). VGX-3100 is
designed to utilize the patient's own immune system to clear
HPV-16/18-associated high-grade precancerous lesions with the aim
of reducing the risk of cancer.
About INOVIO's HPV-Associated DNA Medicines Clinical
Programs
This Phase 2 clinical trial builds on significant clinical
benefits demonstrated with INOVIO's HPV-associated DNA medicines in
multiple clinical trials. Specifically, VGX-3100 in a Phase 2
proof-of-concept trial for cervical dysplasia demonstrated a
complete response in 43 out of 107 patients in regression of
high-grade cervical lesions and elimination of the underlying HPV
infection. Additionally, two out of four metastatic HPV-associated
head and neck cancer patients treated with MEDI0457 and a PD-1
check point inhibitor in a Phase 1 trial experienced a long-term
complete response for more two years and counting. Lastly, a pilot
study of INOVIO's DNA medicine INO-3107 in HPV-caused recurrent
respiratory papillomatosis (RRP) resulted in two out of two
patients delaying surgery due to lack of tumor recurrence.
About INOVIO's DNA Medicines Platform
INOVIO has 15 DNA medicine clinical programs currently in
development focused on HPV-associated diseases, cancer, and
infectious diseases, including coronaviruses associated with MERS
and COVID-19 diseases being developed under grants from the
Coalition for Epidemic Preparedness Innovations (CEPI) and the U.S.
Department of Defense. DNA medicines are composed of optimized DNA
plasmids, which are small circles of double-stranded DNA that are
synthesized or reorganized by a computer sequencing technology and
designed to produce a specific immune response in the body.
INOVIO's DNA medicines deliver optimized plasmids directly into
cells intramuscularly or intradermally using INOVIO's proprietary
hand-held smart device called CELLECTRA®. The CELLECTRA device uses
a brief electrical pulse to reversibly open small pores in the cell
to allow the plasmids to enter, overcoming a key limitation of
other DNA and other nucleic acid approaches, such as mRNA. Once
inside the cell, the DNA plasmids enable the cell to produce the
targeted antigen. The antigen is processed naturally in the cell
and triggers the desired T cell and antibody-mediated immune
responses. Administration with the CELLECTRA device ensures that
the DNA medicine is efficiently delivered directly into the body's
cells, where it can go to work to drive an immune response.
INOVIO's DNA medicines do not interfere with or change in any way
an individual's own DNA. The advantages of INOVIO's DNA medicine
platform are how fast DNA medicines can be designed and
manufactured; the stability of the products, which do not require
freezing in storage and transport; and the robust immune response,
safety profile, and tolerability that have been observed in
clinical trials.
With more than 2,000 patients receiving INOVIO investigational
DNA medicines in more than 7,000 applications across a range of
clinical trials, INOVIO has a strong track record of rapidly
generating DNA medicine candidates with potential to meet urgent
global health needs.
About INOVIO
INOVIO is a biotechnology company focused on rapidly bringing to
market precisely designed DNA medicines to treat and protect people
from infectious diseases, cancer, and diseases associated with HPV.
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 produce a
robust and tolerable immune response. Specifically, INOVIO's lead
candidate VGX-3100, currently in Phase 3 trials for precancerous
cervical dysplasia, destroyed and cleared high-risk HPV 16 and 18
in a Phase 2b clinical trial.
High-risk HPV is responsible for 70% of cervical cancer, 91% of
anal cancer, and 69% of vulvar cancer. Also in development are
programs targeting HPV-related cancers and a rare HPV-related
disease, recurrent respiratory papillomatosis (RRP);
non-HPV-related cancers glioblastoma multiforme (GBM) and prostate
cancer; as well as externally funded infectious disease DNA vaccine
development programs in Zika, Lassa fever, Ebola, HIV, and
coronaviruses associated with MERS and COVID-19 diseases. Partners
and collaborators include Advaccine, ApolloBio Corporation,
AstraZeneca, The Bill & Melinda Gates Foundation, Coalition for
Epidemic Preparedness Innovations (CEPI), Defense Advanced Research
Projects Agency (DARPA)/Joint Program Executive Office for
Chemical, Biological, Radiological and Nuclear Defense
(JPEO-CBRND)/Department of Defense (DOD), HIV Vaccines Trial
Network, International Vaccine Institute (IVI), Kaneka Eurogentec,
Medical CBRN Defense Consortium (MCDC), National Cancer Institute,
National Institutes of Health, National Institute of Allergy and
Infectious Diseases, Ology Bioservices, the Parker Institute for
Cancer Immunotherapy, Plumbline Life Sciences, Regeneron,
Richter-Helm BioLogics, Thermo Fisher Scientific, University of Pennsylvania, Walter Reed Army
Institute of Research, and The Wistar Institute. INOVIO also is a
proud recipient of 2020 Women on Boards "W" designation recognizing
companies with more than 20% women on their board of directors. For
more information, visit www.inovio.com.
CONTACTS:
Media: Jeff
Richardson, 267-440-4211, jrichardson@inovio.com
Investors: Ben Matone, 484-362-0076,
ben.matone@inovio.com
This press release contains certain forward-looking
statements relating to our business, including our plans to develop
and manufacture DNA medicines, our expectations regarding our
research and development programs, and our ability to successfully
manufacture and produce large quantities of our product candidates
if they receive regulatory approval. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in preclinical
studies, clinical trials, product development programs and
commercialization activities and outcomes, our ability to secure
sufficient manufacturing capacity to mass produce our product
candidates, 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 medicines, our ability to support our pipeline of DNA
medicine 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, 2019, our Quarterly Report on Form
10-Q for the quarter ended September 30,
2020 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.
View original
content:http://www.prnewswire.com/news-releases/inovios-vgx-3100-demonstrates-positive-phase-2-efficacy-in-treatment-of-precancerous-anal-dysplasia-caused-by-hpv-1618-301189067.html
SOURCE INOVIO Pharmaceuticals, Inc.