CanSino Biologics to Embrace mRNA-based COVID-19 Vaccine Development—Some Considerations

CanSino Biologics to Embrace mRNA-based COVDI-19 Vaccine Development—Some Considerations

CanSino Biologics is technically leading the pack of SARS-CoV-2 vaccine developers with its investigational Ad5-nCoV leveraging its adenovirus-based viral vector vaccine platform. As of this writing, Phase II trials had already commenced in China.  In fact, TrialSite News showcased the nationwide deal with Canada, evidencing the seriousness of the Chinese company’s progress. Now it just announced a deal with Precision NanoSystems—the pair will collaborate to develop a mRNA lipid nanoparticle vaccine for COVID-19. Precision NanoSystems will work on the early stage development while CanSino Biologics invests to develop the experimental product—from preclinical through clinical, regulatory all the way to commercialization. CanSino Biologics will own the rights to market in Asia (except for Japan) while Vancouver-based Precision NanoSystems secures rest of world including the massive European and North American markets. An interesting move to diversify on the part of CanSino Biologics—does it imply anything about their existing product in Phase II?

The Deal

The two parties announced the development agreement in a joint press release. The parties will leverage Precision NanoSystem’s (PNI) 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 take care of development of the mRNA-LNP vaccine, and CanSino Biologics will be responsible for pre-clinical testing, human clinical trials, regulatory approval and commercialization. As mentioned, CanSino Biologics now holds the commercial rights to the vaccine product in Asia (except Japan) while PNI has the rights for the rest of the world. The parties didn’t agree any financial terms either in payment or royalties. Given the stage of this announcement, an actual vaccine will take some time.

Precision NanoSystem positions its NanoAssemblr® ignite™ with NxGen Technology as a scalable, easy to use and reproducible system that enables the creation of transformative medicines.

Why Now?

Possibly, the company seeks another angle to develop defensive vaccine products targeting COVID-19, reports Amirah Al Idrus in Fierce Biotech. Mr. Al Idrus notes now CanSino can leverage more than just “antigens through a weakened or inactivated form of a virus” and moving forward employ an advanced life sciences-based technology that “give people’s bodies the instructions for those antigens.” Embracing a technology competitors such as Moderna (mRNA-1273) are taking, the body in essence produces antigens that looks like SARS-CoV-2 hence triggering the body to respond and attack. To date, there are no approved mRNA-based vaccines but the theory here is that with this technology, new vaccines could be faster, easier and more economical to develop.

TrialSite News also raises the question whether this announcement has anything to do with the recent national development deal with Canada? Or for that matter, could all be rosy with the existing ‘leader of the vaccine pact’ in Phase II?

Diversification or Something more Dire for CanSino Biologics?

How is the current vaccine coming along? The last news out was that It had moved to Phase II. But could this be an effort to diversify away from the Ad5-nCoV product? The company announced that in parallel to developing Ad5-nC0V they seek to team with PNI to develop and commercialize the mRNA-LNP based vaccine. CEO and co-founder Dr. Xuefeng Yu suggests he is hedging his bets: “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 Value Proposition

They position themselves as a global leader in technologies and solutions for the development and manufacture of nanomedicine. 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.”

Investors Be Careful

CanSino Biologics (OTC: CASBF) stock price has skyrocketed 380% in 2020—Yahoo Finance reports it has become a “darling of Hong Kong investors.” Its market capitalization has gone over $2 billion from next to nothing.

But investors should be wary of the vaccine investment game—it isn’t one. It actually represents an incredibly risky proposition and not for the squeamish or faint of heart.

In Yahoo FinanceCastor Pang, head of research at Core Pacific-Yamaichi International Hong Kong, conveyed to the Fortune reader base: “No one knows how much CanSino is worth.” So, Pang suggests the risks are high as they are only in Phase II with their current vaccine; TrialSite News suggests this latest partnership indicates a move to possibly diversify away from a technology that may be expensive and cumbersome to scale with? 

A More Modern Platform

Undoubtedly, embracing a more modern, advanced, and disruptive technology makes sense but it could also be read as a move to consider a more sustainable Plan B. mRNA-based vaccines are novel—they involve the incorporation of a piece of mRNA coding for a protein on the surface of the spike (S) protein in the case of the novel coronavirus known as SARS-CoV-2. Thereafter, the mRNA infuses into a person’s cells by exploiting that individual’s own DNA apparatus to make the protein, thereby triggering the individual’s immune system to react—in the process, learning to recognize and strike back at the virus when a person is infected.

With such potential, perhaps not only is CanSino Biologic’s Ad5-nCoV -based investigational candidate in Phase II  coming along just fine—but that also this news is actually indicative of their strength to diversify and develop another more advanced product in parallel. At $27.80 a share, they are at all time highs. But be careful. More often than not in biotech, what goes up can come down fast.