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In an amendment to their existing contract manufacturing agreement, Celsian and Poly Pharm expand GEN-1 program collaboration to add clinical and commercial batches of investigational vaccine.
Celsion Corporation, a clinical-stage company with a focus on DNA-based immunotherapy and next-generation vaccines, and Hainan Poly Pharm Co., a generics manufacturer, announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine in a Sept. 17, 2021, press release. Under the terms of the amended agreement, Poly Pharm will manufacture clinical and commercial batches (pending approval for use for the latter) for Celsion’s vaccine based on its TheraPlas technology. TheraPlas underlies Celsion’s GEN-1 product and its PLACCINE vaccine technology platform.
Poly Pharm is experienced with chemistry, manufacturing, controls, process development, and current good manufacturing processes, including process optimization and manufacturing services to help customers advance new drug development projects. FDA, EMA, China’s National Medical Products Administration, and the World Health Organization have approved its sites and compounds, according to the company press release.
Madame Fang, CEO of Hainan Poly Pharm, said in the press release. “Poly Pharm and Celsion have a successful cooperation on GEN-1 and have been successfully manufacturing 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 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 as it may address global vaccine storage and distribution needs.”
“This is the second plasmid DNA-based investigational new drug project with Hainan Poly Pharm,” said Michael Tardugno, chairman, president, and CEO of Celsion in the press release. “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.”