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TheraPlas power Celsion's GEN-1 product and PLACCINE vaccination technology platform.
FREMONT, CA: Celsion Corporation, a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm, a generics manufacturer devoted to offering therapeutic-value services and products to customers and patients around the world, recently amended its existing contract manufacturing agreement to take in development work for Celsion's investigational DNA-based COVID-19 vaccine.
Under the conditions of the amended agreement, Poly Pharm will produce clinical batches and, if accepted for use, will also manufacture commercial batches for Celsion's vaccine depending on its TheraPlas technology. TheraPlas power Celsion's GEN-1 product and PLACCINE vaccination technology platform.
Madame Fang, Chief Executive Officer of Hainan Poly Pharm, said, "Poly Pharm is a fully-integrated specialty pharmaceutical company with rich CDMO experience. Poly Pharm and Celsion have flourishing cooperation on GEN-1 and have successfully manufactured clinical batches of GEN-1 to support Celsion's OVATION 2 Study in advanced ovarian cancer. The GEN-1 collaboration and the DNA-based COVID-19 vaccine program demonstrate our expertise in the highly cost-effective manufacturing of nucleic acid-based finished drugs. We are glad that a DNA-based vaccine can be our second cooperative project. Celsion's DNA vaccine technology platform is a promising platform to address global vaccine storage and distribution needs. We are pleased that Celsion has recognized Poly Pharm's skills and dependability, especially with difficult-to-manufacture products, and we are looking forward to helping address the global COVID-19 pandemic."
Poly Pharm has expertise in chemistry, manufacturing, and controls (CMC), process development, good manufacturing practices (cGMP), and process optimization and manufacturing services to assist customers with innovative medication development. The US Food and Drug Administration (FDA), the European Medicines Agency (EMA), China's National Medical Products Administration (NMPA), and the World Health Organization (WHO) have all approved its sites and medicinal substances.
"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 enjoyed a productive working relationship with Poly Pharm delivering quality product efficiently and are delighted to expand our contract manufacturing agreement with them," said Michael Tardugno, Chairman, President, and Chief Executive Officer, Celsion.