Inovio Pharmaceuticals, Inc. (NASDAQ:INO) announced today it has
appointed Prakash Bhuyan, M.D, Ph.D., as Vice President, Clinical
Development. Dr. Bhuyan will lead the clinical development of
Inovio’s programs to treat HPV-related pre-cancers (dysplasia).
Inovio will take VGX-3100, its treatment for cervical dysplasia
caused by the human papillomavirus (HPV), into a phase 3
registration study this year. He will report to Dr. Mark Bagarazzi,
Chief Medical Officer.
Prior to joining Inovio, Dr. Bhuyan was Senior
Director, Pfizer Vaccine Research, where he led the pivotal
clinical study that helped achieve FDA approval in 2014 of the
first meningococcal B vaccine to be licensed in the U.S.
Prior to Pfizer, Dr. Bhuyan directed the
development and execution of multiple vaccine clinical trials for 4
licensed vaccines at Merck and successfully led an investigational
hexavalent pediatric vaccine from phase 2 into phase 3 trials. He
earned his M.D. and his Ph.D. in Immunology from the University of
Texas Southwestern Medical Center. He completed his fellowship in
Infectious Diseases at the University of Pennsylvania, where he
currently serves as adjunct assistant professor.
Dr. Mark Bagarazzi, Chief Medical Officer, said,
"Dr. Prakash Bhuyan has demonstrated leadership in advancing
vaccines to licensure and we are pleased to bring him to Inovio
where he will focus on advancing the development of VGX-3100. He
will be instrumental in guiding VGX-3100, our immunotherapy for
cervical pre-cancer, into phase 3 later this year.”
Inovio’s phase 2b trial showed that
histopathological regression of high grade cervical neoplasia
(CIN2/3) to low grade neoplasia (CIN1) or no disease occurred in a
significantly higher percentage of VGX-3100 recipients compared
with placebo recipients. Furthermore, concomitant histopathological
regression and clearance of HPV occurred in a significantly higher
percentage of VGX-3100 recipients compared with placebo recipients.
HPV-specific CD8+ "killer T cells" were also generated in the blood
as well as a substantial infiltration of CD8+ cells in the cervical
tissue of VGX-3100 recipients, underscoring the role played by
Inovio's best-in-class T-cell responses. VGX-3100 was safe and
generally well-tolerated.
In VGX-3100-treated women whose high grade
dysplasia regressed, most (43 out of 53) completely cleared their
lesions to normal (complete response). Moreover, eighty percent of
VGX-3100-treated women whose dysplasia regressed also eradicated
the infecting HPV genotype (i.e. 16 or 18) from the cervix. This is
an important outcome as persistence of the virus is associated with
recurrence of the disease.
In 2015, The Lancet reported on results of
Inovio’s phase 2b trial in an article entitled, "Safety, efficacy,
and immunogenicity of VGX-3100, a therapeutic synthetic DNA vaccine
targeting human papillomavirus 16 and 18 E6 and E7 proteins for
cervical intraepithelial neoplasia 2/3: a randomized, double-blind,
placebo-controlled phase 2b trial," by C. Trimble, et al.
About VGX-3100
Inovio's VGX-3100 is an immunotherapy containing
two DNA plasmids targeting the E6 and E7 oncogenes of HPV types 16
and 18. These oncogenes are responsible for transforming
HPV-infected cells into pre-cancerous and cancerous cells. The
treatment is administered to patients by injection into muscle
(typically in the arm), followed by electroporation using Inovio's
CELLECTRA® device. VGX-3100 has been shown to induce a robust
immune response against the E6 and E7 oncogenes associated with HPV
types 16 and 18.
About HPV and Cervical
Dysplasia
Human papillomavirus (HPV) is the most common
sexually transmitted disease. At any given time, approximately 11%
percent of the world population is infected with HPV. Roughly 75%
or less of HPV 16/18 infections are cleared by naturally occurring
immune responses in women of all ages.
Persistent HPV infection can lead to dysplasia,
or premalignant changes, in cervical cells. HPV types 16 and 18
cause 70% of cervical dysplasia and cervical cancer cases. Each
year in the United States, 1.4 million women are diagnosed with
CIN1 and 300,000-400,000 women are diagnosed with CIN2/3. All
cervical cancers arise from untreated CIN2/3.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that is generating T cells in vivo in
high quantity that are fully functional and whose killing capacity
correlates with relevant clinical outcomes with a favorable safety
profile. With an expanding portfolio of immune therapies, the
company is advancing a growing preclinical and clinical stage
product pipeline. Partners and collaborators include MedImmune,
Roche, University of Pennsylvania, DARPA, GeneOne Life Science,
Drexel University, NIH, HIV Vaccines Trial Network, National Cancer
Institute, U.S. Military HIV Research Program, and University of
Manitoba. 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 and our capital resources. 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 (including, but not limited to, the fact that
pre-clinical and clinical results referenced in this release may
not be indicative of results achievable in other trials or for
other indications, that the studies or trials may not be successful
or achieve the results desired, including safety and efficacy for
VGX-3100 and INO-3112, that pre-clinical studies and clinical
trials may not commence or be completed in the time periods
anticipated, that results from one study may not necessarily be
reflected or supported by the results of other similar studies and
that results from an animal study may not be indicative of results
achievable in human studies), 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 broad pipeline of SynCon® active immune therapy and vaccine
products, our ability to advance our portfolio of immune-oncology
products independently, 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 the company or its collaborators,
including alternatives that may be more efficacious or
cost-effective than any therapy or treatment that the company and
its collaborators hope to develop, our ability to enter into
partnerships in conjunction with our research and development
programs, evaluation of potential opportunities, issues involving
product liability, issues involving patents and whether they or
licenses to them will provide the company 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 the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's 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, 2014,
our Form 10-Q for the quarter ended September 30, 2015, and other
regulatory filings from time to time. There can be no assurance
that any product in Inovio's pipeline will be successfully
developed or manufactured, that final results of clinical studies
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.
CONTACTS:
Investors: Bernie Hertel, Inovio Pharmaceuticals, 858-410-3101, bhertel@inovio.com
Media: Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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