Celsion Corporation Adds Key Resources to its Vaccine Development Initiative and Clinical Trial Capabilities

LAWRENCEVILLE, N.J., Oct. 05, 2021 (GLOBE NEWSWIRE) — 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 ResearchSubeena Sood, Ph.D. promoted to Senior Manager, Biology and Preclinical StudiesBeth 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 [email protected] LHA Investor RelationsKim Sutton [email protected] # # #