Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine
Expands GEN-1 Program Collaboration to Add Clinical and Commercial Batches of Investigational Vaccine
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
Commenting on the agreement,
About the PLACCINE platform
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. It is delivered via a synthetic delivery system and has the potential to be easily modified to create vaccines against a multitude of infectious diseases, addressing:
- Viral Mutations: PLACCINE may offer broad-spectrum and mutational resistance (variants) by targeting multiple antigens on a single plasmid vector.
- Enhanced Efficacy: The potent immune modifiers such as cytokines and chemokines may improve humoral and cellular responses to viral antigens and can be incorporated in the plasmid.
- Durable Efficacy: PLACCINE delivers a DNA plasmid-based antigen that can result in durable antigen exposure and a robust vaccine response to viral antigens.
- Storage & Distribution: PLACCINE allows for stability that is compatible with manageable vaccine storage and distribution.
- Dosing & 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 Poly Pharm. Co. Ltd. a Chinese generics manufacturer dedicated to providing therapeutic-value products and services to patients and customers around the world, including R&D, manufacturing and marketing. Poly Pharm is one of the few listed biopharmaceutical companies which meet the EU and US cGMP standard in
Founded in 1992, Poly has built a product portfolio including active pharmaceutical ingredients (API) and finished products and has earned a reputation for high-quality products. Poly Pharm initiated its international registration program in 2005. Since 2012, Poly Pharm has received inspections from various global authorities including the FDA, EMA, NMPA and
With the approval of products for marketing by the EMA and
Forward-looking statements in this news release are made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, statements relating to the offering and the use of proceeds therefrom, 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
Executive Vice President and CFO
LHA Investor Relations
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Source: Celsion CORP