Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities
October 05 2021 - 9:00AM
Celsion Corporation (NASDAQ:
CLSN), a clinical-stage development company focused on
DNA-based immunotherapy and next-generation vaccines, announces the
strengthening of its management team with a new hire and a
promotion in its vaccine development program, and the hiring of a
veteran clinical trial project manager for its Phase II GEN-1
immunotherapy study in advanced ovarian cancer. These changes all
are effective immediately and are as follows:
- Carlo Iavarone,
Ph.D. joins as Senior Director, Non-Clinical Research
- Subeena Sood,
Ph.D. promoted to Senior Manager, Biology and Preclinical
Studies
- Beth J.
Llewellyn joins as Director of Clinical Operations
Dr. Iavarone will serve as project leader for
the PLACCINE vaccine initiative. He will be based in Huntsville,
Ala. and brings to Celsion more than 15 years of experience
investigating and leading the development of vaccines, including
molecular target identification and characterization of RNA
vaccines. Most recently, from 2019 until 2021 he was a science
advisor for both Guidepoint and Clora, providing input for a viral
target and RNA vaccine delivery system. Dr. Iavarone joined
GlaxoSmithKline in 2015 as a senior scientist studying small
molecules and RNA vaccines in animal and human cell lines. From
2007 until 2015 he held positions of increasing responsibility at
Novartis, including as a principal scientist for a melanoma vaccine
project.
Dr. Iavarone has authored more than 15 papers on
oncology and vaccine research that were published in peer-reviewed
journals. He holds a Ph.D. in Molecular Pathology and
Physiopathology from Federico Il University in Naples, Italy, and
did his post-doctoral work at Novartis in Siena, Italy.
Dr. Sood is responsible for assay development
and in vivo experiments for the PLACCINE DNA vaccine and gene
therapy program, and also is based in Huntsville. She has
experience with several pharmaceutical companies in experiment
design, pharmacological and biochemical assays, manufacturing
process design and development, and optimization and implementation
of Quality by Design. Dr. Sood joined Celsion as manager of animal
research in 2019, where she has designed and conducted all
preclinical research. Prior to Celsion, since 2017 she was a
Formulation Scientist II at Novocol Healthcare. From 2016 to 2017
Dr. Sood was a Research Associate II at Nektar Therapeutics, and
from 2015 to 2016 she was a Quality Control Chemist I at Par
Pharmaceuticals. She also worked in regenerative medicine as a
Research Fellow at Medstar Heart Institute, Washington Hospital
Center in Washington, D.C. from 2010 to 2013.
Dr. Sood has authored more than 25 articles
published in peer-reviewed journals, mainly in the area of
cardiology and oxidative stress. She received her Ph.D. in
Pharmacology from the All India Institute of Medical Sciences in
New Delhi, and was a post-doctoral associate at the Baylor College
of Medicine.
Ms. Llewellyn is responsible for the management
of the ongoing Phase II OVATION 2 Study with GEN-1 in advanced
ovarian cancer and will be based at our corporate office in
Lawrenceville. Previously she was the President of 2L Pharma, a
clinical operations consulting firm she founded in 2014. Her work
included preparing protocols for Investigational New Drug
submissions to the U.S. Food and Drug Administration, clinical
trial site qualification and compliance and functioning as a
liaison between clinical trial sites, contract research
organizations and study sponsors. From 2011 to 2014 she was a
Clinical Operations Management Consultant for Alba Therapeutics
with oversight for all clinical activities related to a Phase IIb
protocol investigating the use of a novel pharmaceutical agent for
celiac disease. From 2010 to 2011 she was a Clinical Research
Associate for Nabi Biopharmaceuticals, where she was responsible
for providing in-house and field study monitoring, operational
guidance and general assistance for multiple protocols
investigating the use of a novel vaccine.
Ms. Llewellyn has been involved in over 30
clinical trials in a variety of therapeutic areas including
oncology and infectious disease. She received a B.A. in psychology
from Ohio University. Her graduate training in experimental
psychology included studies in research design and statistical
analysis.
“As we continue to advance the development of
our PLACCINE DNA-mediated vaccine platform and or Phase II study of
GEN-1, we are delighted to deepen our bench strength with these
talented and experienced professionals,” said Michael H. Tardugno,
Chairman, President and Chief Executive Officer of Celsion. “Dr.
Iavarone brings impressive clinical development experience
particularly in RNA vaccines, which is so important Celsion’s work
to develop a SARS-CoV-2 vaccine utilizing a DNA plasmid that
encodes for multiple viral antigens.”
“Dr. Sood has been instrumental in the
successful development of assays used to evaluate biological
activity of our first generation of vaccines. She has proven
herself to be a capable scientific leader, whose expertise will be
relied upon as we complete our preclinical work to establish proof
of concept using for the PLACCINE platform Covid-19 as a benchmark
vaccine.”
“Lastly, as we advance our Phase 2 study with
GEN-1 in advanced ovarian cancer, we welcome Ms. Llewellyn to
Celsion. She is charged with ensuring that trial enrollment
proceeds as planned, and we are confident she will capably address
any protocol issues that might arise,” Mr. Tardugno continued.
“Overall, we believe that with this strengthened team we are better
able to realize the promise of Celsion’s technologies for the
benefit of patients and our stockholders.”
About Celsion
Corporation
Celsion is a fully integrated, clinical stage
biotechnology company focused on advancing a portfolio of
innovative cancer treatments, including immunotherapies, DNA-based
therapies and directed chemotherapies through clinical trials and
eventual commercialization. The company’s product pipeline includes
GEN-1, a DNA-based immunotherapy for the localized treatment of
ovarian cancer. ThermoDox®, a proprietary heat-activated liposomal
encapsulation of doxorubicin, is under investigator-sponsored
development for several cancer indications. Celsion also has two
feasibility stage platform technologies for the development of
novel nucleic acid-based immunotherapies and other anti-cancer DNA
or RNA therapies. Both are novel synthetic, non-viral vectors with
demonstrated capability in nucleic acid cellular transfection. For
more information on Celsion, visit www.celsion.com.
Forward-looking Statements
Forward-looking statements in this news release
are made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. These statements are
based upon current beliefs, expectation, and assumptions and
include statements regarding the platform having the potential to
provide broad protection against coronavirus disease 2019
(COVID-19), and possible future mutations of SARS-CoV-2 or other
coronaviruses. These statements are subject to a number of risks
and uncertainties, many of which are difficult to predict,
including the ability of the Company’s platform to provide broad
protection against COVID-19, and possible future mutations of
SARS-CoV-2 or other coronaviruses, the issuance of a patent to the
Company for use of its technology platform for treating or
preventing infection with the SARS-CoV-2 virus that causes
COVID-19, unforeseen changes in the course of research and
development activities and in clinical trials; the uncertainties of
and difficulties in analyzing interim clinical data, particularly
in small subgroups that are not statistically significant; FDA and
regulatory uncertainties and risks; the significant expense, time
and risk of failure of conducting clinical trials; the need for
Celsion to evaluate its future development plans; possible
acquisitions or licenses of other technologies, assets or
businesses; possible actions by customers, suppliers, competitors
or regulatory authorities; and other risks detailed from time to
time in the Celsion's periodic filings with the Securities and
Exchange Commission. Celsion assumes no obligation to update or
supplement forward-looking statements that become untrue because of
subsequent events, new information or otherwise.
Celsion Investor ContactJeffrey W.
ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
LHA Investor RelationsKim Sutton
Golodetz212-838-3777kgolodetz@lhai.com
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