BEIJING – Besides advancing its recombinant adenovirus type-5 vector (Ad5) vaccine for COVID-19, Cansino Biologics Inc. is making a new attempt to develop an mRNA lipid nanoparticle (mRNA-LNP) vaccine together with Canadian company Precision Nanosystems Inc., of Vancouver, British Columbia.

“Work has already started between the two parties, and we are hopeful to progress a candidate to the start of a phase I clinical study within 12 months,” Precision CEO James Taylor told BioWorld.

The news came just a day before Abnova Corp. and Pharmajet Inc. revealed their joint efforts in developing an mRNA vaccine with a needle-free injection system. More than 10 companies are now known to be developing mRNA vaccine candidates.

Precision will develop the mRNA-LNP vaccine, while China, Tianjin-based Cansino will take charge of preclinical testing, clinical trials, regulatory approval and commercialization. Cansino also holds the rights to commercialize the vaccine in Asia, except Japan, while Precision retains rights for the rest of the world.

Precision said it will contribute its RNA vaccine platform, which includes a lipid nanoparticle delivery system and the Nanoassemblr manufacturing technology to help move the vaccine candidate to human trials faster. Taylor said he believes their candidate will be able to stand out from other vaccine candidates being developed for the pandemic.

“This mRNA vaccine will use a novel lipid delivery technology and the proven microfluidics-based scale-up and manufacturing platform from Precision,” he explained. “We have developed novel lipid formulations specific for vaccine applications and believe these formulations can enable the development of a more potent vaccine candidate, thus enabling less antigen to be used.”

Precision also said the Nanoassemblr platform enables scalable, high-throughput, reproducible centralized or regional manufacturing of nanomedicines. Taylor added that the platform for manufacturing vaccine drug products is “a turnkey solution with a small footprint” and “can be used for in-country or decentralized manufacturing of the COVID-19 [vaccine] anywhere in the world.”

The Chinese vaccine developer, which has been developing vaccine candidates with its adenovirus-based viral vector vaccine technology platform, is keen to try out a new approach.

“RNA vaccines are a disruptive technology as they do not require cell culture, utilize synthetic delivery and have a smaller manufacturing footprint,” said Cansino CEO Xuefeng Yu.

He added that this approach could help accelerate vaccine development and “revolutionize the vaccine industry.”

Cansino’s primary vaccine candidate for COVID-19, Ad5-nCoV, was developed with its existing adenovirus-based viral vector vaccine technology platform, which utilizes adenoviruses as viral vectors to deliver vaccine antigens to the human cell. Another of the company’s vaccine products, Ad5-EBOV for Ebola, was also derived from that platform.

mRNA vaccines advancing fast

According to The PHG Foundation, a Cambridge, U.K.-based think tank on emerging health technologies, RNA vaccines are faster and cheaper to produce than traditional vaccines as well as safer for patients.

The group noted that mRNA vaccines can be produced more rapidly in the laboratory in a process that can be standardized.

In a webinar in March, Cansino’s Yu raised concerns of manufacturability. He said vaccine developers need to consider whether their technology allows for mass production of their vaccine candidates.

The Chinese company said it will devote efforts to develop the mRNA-LNP vaccine in parallel with the clinical development of Ad5-nCoV, which is undergoing phase II trials in China and phase I/II trials in Canada. On May 13, the company revealed a collaboration with the National Research Council of Canada to start the trial, aiming for an accelerated phase III trial.

It added that it plans to carry out phase III for Ad5-nCoV in countries with high incidence rates and clinical study capabilities.

Meanwhile, Moderna Inc. has garnered the most attention for an mRNA vaccine, with its mRNA-1273 being one of the latest-stage vaccines currently in development. The company reported positive interim phase I data results for the vaccine candidate and isolated a dose range. Moderna is moving into the phase II process with 600 healthy volunteers, and a phase III trial is expected to begin in July with a regulatory filing as early as 2021.

“We're talking a matter really of weeks before we hope to be launching the phase III, [and] there will continuously be data coming out of this phase I,” said Moderna’s chief medical officer, Tal Zaks. The phase III dose is expected to land between 25 µg and 100 µg.

Other biotech companies working on mRNA vaccines for COVID-19 include Arcturus Therapeutics Inc., Biontech Inc., Curevac AG, Pfizer Inc., Sanofi Pasteur, Translate Bio Inc. and Stermirna Therapeutics Co. Ltd.

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