The two companies will use PNI’s proprietary RNA vaccine platform to advance a COVID-19 mRNA-LNP vaccine into the clinic based on regulatory approvals and commercialization in various regions. PNI will handle development of the vaccine and CanSinoBIO will take care of preclinical testing, human clinical trials, regulatory submissions and commercialization.
CanSinoBIO will hold the commercialization rights in Asia except Japan, while PNI will hold rights for the rest of the world. No financial details were disclosed.
CanSinoBIO is leading Asian development of a COVID-19 vaccine. The company has a collaboration with a Chinese military medical institute, The Academy of Military Medical Sciences. The virologist leading the program is Chen Wei, a general with the People’s Liberation Army.
On state TV in April, she stated, “In some areas and on some issues, we must have scientific self-confidence. With more than a billion people, we can’t rely on others. We must rely on our own scientific strength to protect our people.”
The Chinese government and biopharma industry are also fast-tracking vaccine development. China was the source of the original outbreak of the virus and has taken some criticism for its early handling of the epidemic as well as questions into whether the virus came from a laboratory instead of evolved in nature.
At WHO’s annual meeting Monday, Chinese President Xi Jinping said the country had acted with “openness, transparency and responsibility” and China supported the idea of a “comprehensive review” of the global response.
CanSinoBIo’s Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) candidate (Ad5-nCoV) is in a Phase II clinical trial in China. The company recently announced a collaboration deal with the National Research Council of Canada to launch clinical testing of the vaccine in Canada in parallel to clinical development of Ad5-nCoV.
“Our team has been dedicated to developing safe and effective vaccines to fight against the COVID-19 pandemic,” said Xuefeng Yu, co-founder, chairman and chief executive officer of CanSinoBIO. “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 leader in nanomedicines. It NanoAssemblr systems are in more than 400 drug development and manufacturing efforts in oncology, infectious diseases and rare diseases. The company also developed a library of lipid formulations for nucleic acid deliver.
“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,” said Andrew Geall, chief scientific officer at PNI.
Gene therapies and some vaccines rely on delivery of genetic material into the body leveraging a virus, typically a harmless version of an adeno-associated virus (AAV). A lipid delivery system bypasses the viral vector and utilizes liposomes, which are essentially a tiny fat droplet, although a more detailed description is a spherical sac of phospholipid molecules that enclose a water droplet.
According to PNI, there were at least 15 liposomal drug formulations as of 2017 on the market for a variety of indications, including cancer, fungal infections, macular degeneration, pain management and vaccines.
mRNA vaccines are a new technology, one being leveraged by other leaders in the COVID-19 vaccine race, including Moderna and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), and Pfizer and Germany’s BioNTech. A messenger RNA vaccine takes a piece of mRNA that codes for a protein on the surface of the virus, in the case of SARS-CoV-2, the virus that causes COVID-19, typically the spike (S) protein. They then insert it into a virus or a liposome, which is then injected into the body. The mRNA integrates into cells, using their own DNA machinery to manufacture the protein, which the immune system reacts to, learning to identify and attack the virus if the person is infected.