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LAWRENCEVILLE, NJ and HAINAN, China, September 17, 2021 (GLOBE NEWSWIRE) – Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co. Ltd. (Shenzhen Stock Exchange 300630.SZ), a generic manufacturer dedicated to providing products and services of therapeutic value to patients and customers worldwide, today announced an amendment to its existing contract manufacturing agreement to include development work for Celsion’s experimental DNA-based COVID-19 vaccine. Under the amended agreement, Poly Pharm will manufacture clinical lots and, if approved for use, will also manufacture commercial lots for Celsion’s vaccine based on its TheraPlas technology. TheraPlas is the basis of Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.
Poly Pharm is experienced in chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers move forward new drug development projects. Its sites and pharmaceutical compounds have been approved by the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Medical Products Administration (NMPA) of China and the World Health Organization (WHO ).
Madam Fang, CEO of Hainan Poly Pharm, said, “Poly Pharm is a fully integrated specialty pharmaceutical company with rich experience in CDMO. Poly Pharm and Celsion have a successful cooperation on GEN-1 and have successfully manufactured clinical batches of GEN-1 to support Celsion’s OVATION 2 study in advanced ovarian cancer. GEN-1 Collaboration and DNA-Based COVID-19 Vaccine Program Demonstrate Our Expertise in Highly Cost-Effective Manufacturing of Finished Nucleic Acid Drugs. We are happy that a DNA-based vaccine can be our second cooperative project. Celsion’s DNA Vaccine Technology Platform is a promising platform as it can meet global vaccine storage and distribution needs. We are delighted that Celsion has recognized Poly Pharm’s skill and reliability, especially with hard-to-manufacture products, and we look forward to helping address the global COVID-19 pandemic. “
Commenting on the deal, Michael Tardugno, CEO of Celsion, said: “This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm. Our first collaboration is GEN-1, which incorporates a DNA plasmid encoding IL-12 into a unique nanoparticle delivery system. GEN-1 immunotherapy is being evaluated in the Phase I / II OVATION 2 study in combination with chemotherapy for patients with newly diagnosed advanced ovarian cancer. We have maintained a productive working relationship with Poly Pharm by providing quality products in an efficient manner and are delighted to extend our contract manufacturing agreement with them.
About the PLACCINE platform
PLACCINE is Celsion’s proprietary plasmid and DNA delivery technology and is the subject of a provisional patent application that covers a broad range of next-generation DNA vaccines. An adaptation of the Company’s TheraPlas technology, PLACCINE is a DNA vaccine technology platform characterized by a single plasmid DNA with multiple coding regions. The plasmid vector is designed to express multiple pathogenic antigens as well as a potent immune modifier. It is delivered via a synthetic delivery system and can be easily modified to create vaccines against a multitude of infectious diseases, by addressing:
- Viral mutations: PLACCINE may offer broad spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid vector.
- Improved efficiency: Strong immune modifiers such as cytokines and chemokines can enhance humoral and cellular responses to viral antigens and can be incorporated into the plasmid.
- Sustainable efficiency: PLACCINE provides a plasmid DNA-based antigen that can result in long-lasting antigen exposure and a robust vaccine response to viral antigens.
- Storage and distribution: PLACCINE provides stability compatible with manageable storage and distribution of vaccines.
- Dosage and administration: PLACCINE is a synthetic delivery system that should require a simple injection that does not require viruses or special equipment to deliver its payload.
About Hainan Poly Pharm
Hainan Polypharmacy. Co. Ltd. a Chinese generics manufacturer dedicated to providing products and services of therapeutic value to patients and customers around the world, including R&D, manufacturing and marketing. Poly Pharm is one of the few listed biopharmaceutical companies to meet EU and US cGMP standards in China. Poly Pharm not only has manufacturing capability ranging from API to finished products, but also provides CDMO service to customers in ophthalmic preparation, topical preparation, vaccine and cancer biologic drugs, including including production from clinical lots to commercial lots.
Founded in 1992, Poly has built a product portfolio comprising active pharmaceutical ingredients (APIs) and finished products and has earned a reputation for high quality products. Poly Pharm launched its international registration program in 2005. Since 2012, Poly Pharm has received inspections from various global authorities including FDA, EMA, NMPA and WHO, with positive results validating its compliance cGMP and its quality control.
With the approval of the products for marketing by the EMA and the US FDA, and the distribution of its products in the EU markets, Poly Pharm entered the global market. In 2017, Poly Pharm successfully completed an initial public offering and listed its shares on the Shenzhen Stock Exchange (300630.SZ).
About Celsion Corporation
Celsion is a fully integrated clinical-stage biotechnology company focused on advancing a portfolio of innovative cancer treatments, including immunotherapies and DNA-based therapies; and a platform for the development of nucleic acid vaccines currently focused on SARS-CoV-2. The company’s product portfolio includes GEN-1, a DNA-based immunotherapy for the localized treatment of ovarian cancer. ThermoDox®, a patented liposomal encapsulation of heat-activated doxorubicin, is under researcher-sponsored development for several cancer indications. Celsion also has two technological platforms for the development of new nucleic acid-based immunotherapies and other DNA or RNA-based cancer therapies. Both are novel, synthetic, non-viral vectors with demonstrated ability in cellular nucleic acid transfection. For more information on Celsion, visit www.celsion.com.
The forward-looking statements contained in this press release are made in accordance with the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that these forward-looking statements involve risks and uncertainties, including, without limitation, statements relating to the offer and use of the product thereof, unforeseen changes in the course of research and development activities and in clinical trials; uncertainties and difficulties in analyzing intermediate clinical data, especially 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 assess its future development plans; possible acquisitions or licenses of other technologies, assets or companies; possible actions of customers, suppliers, competitors or regulatory authorities; and other risks detailed from time to time in Celsion’s periodic filings with the Securities and Exchange Commission. Celsion assumes no obligation to update or supplement any forward-looking statements that become false due to subsequent events, new information or otherwise.
Jeffrey W. Church
Executive Vice President and Chief Financial Officer
LHA Investor Relations
Kim Sutton Golodetz
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