May 20 2020: CanSino Biologics Inc. (CanSinoBIO, HK6185) and Precision NanoSystems (PNI) today announced a co-development agreement of a mRNA lipid nanoparticle (mRNA-LNP) vaccine against COVID-19. The parties will leverage PNI’s proprietary RNA vaccine platform, comprising of lipid nanoparticle delivery system and the NanoAssemblr® manufacturing technology, to rapidly advance a COVID-19 mRNA-LNP vaccine candidate towards human clinical testing and pursuant to regulatory approvals, commercialization in different regions. PNI will be responsible for development of the mRNA-LNP vaccine and CanSinoBIO will be responsible for pre-clinical testing, human clinical trials, regulatory approval and commercialization. CanSinoBIO has rights to commercialize the vaccine product in Asia (except Japan) with PNI retaining rights for rest of the world. The agreement includes undisclosed payments and royalties.
CanSinoBIO is at the forefront of COVID-19 vaccine development efforts with their Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) candidate (the Ad5-nCoV ) currently in phase II clinical trial in China. CanSinoBIO recently announced a collaboration with the National Research Council of Canada to initiate clinical testing of the Ad5-nCoV vaccine candidate in Canada. In parallel to clinical development of Ad5-nCoV, CanSinoBIO wants to join efforts with PNI to develop and commercialize a mRNA-LNP based vaccine. CanSinoBIO’s co-founder, chairman and CEO Dr. Xuefeng Yu said, “Our team has been dedicated to developing safe and effective vaccines to fight against the COVID-19 pandemic. Since RNA vaccines are a disruptive technology as they do not require cell culture, utilize synthetic delivery and have a smaller manufacturing footprint, our partnership with PNI to advance a mRNA-LNP vaccine candidate will not only help accelerate the process, but will also potentially revolutionize the vaccine industry.”
PNI is a global leader in technologies and solutions for the development and manufacture of nanomedicines. With over 400 NanoAssemblr® systems placed, PNI supports its customers’ drug development and manufacturing efforts in the areas of oncology, infectious diseases, and rare diseases. To offer a complete solution for drug developers, PNI has developed a library of lipid formulations for nucleic acid delivery. Dr. Andrew Geall, CSO at PNI and a scientific leader in the field of non-viral delivery of mRNA vaccines said, “PNI has developed lipid formulations that are specifically designed for vaccine applications and we look forward to working with CanSinoBIO to bring the vaccine to patients.” PNI’s NanoAssemblr® GMP System and manufacturing process, now transferred to several customers, plays a crucial role in scalable, high throughput, reproducible centralized or regional manufacturing of nanomedicines. Dr. James Taylor, co-founder and CEO of PNI said, “We are very excited to partner with CanSinoBIO, an innovative biopharmaceutical company leading the way for COVID-19 vaccine development. We strongly believe PNI’s NxGen microfluidic technology and our expertise will enable the rapid development and manufacturing of an effective mRNA-LNP vaccine for COVID-19, and provides the foundation for future pandemic preparedness.
