On Sept. 16, 2021, Celsion and Hainan Poly Pharm announced an amendment to their existing contract manufacturing agreement to include development work for Celsion’s investigational DNA-based COVID-19 vaccine. Under the terms of the amended agreement, Poly Pharm will manufacture clinical batches and, if approved for use, will also manufacture commercial batches for Celsionﾒs vaccine based on its TheraPlas technology.

Poly Pharm is experienced with chemistry, manufacturing and controls (CMC), process development and good manufacturing processes (cGMP), including process optimization and manufacturing services to help customers advance new drug development projects. Its sites and pharmaceutical compounds have been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), China’s National Medical Products Administration (NMPA) and the World Health Organization (WHO).

PLACCINE is Celsion’s proprietary plasmid and DNA delivery technology and 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 pathogen antigens along with a potent immune modifier.