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Unlike RNA vaccines, DNA vaccines don’t have to be stored at extremely cold temperatures – they can be kept in a refrigerator for more than a year and at room temperature for more than a month – and they’re easier to scale up for manufacturing. Recipients only require one dose instead of two.
After the first vaccine candidate starts trials, Entos plans to begin trials for the second – a pan-coronavirus DNA vaccine that includes all of the known variants of COVID-19.
“As far as timing, our Phase 1 and Phase 2 (trials) are mixed together, so as soon as we get the Phase 1 safety data, we’ll move directly into Phase 2,” Lewis said.
Phase 3, which is the final clinical trial stage before emergency authorization can be granted, would start shortly after Phase 2 trials conclude.
Lewis said both Moderna and Pfizer-BioNTech were required to have 30,000 participants for Phase 3 trials, but that size is “out of reach” for Entos due to the $250-million pricetag.
But the company is hoping that by the time its vaccine candidates reach Phase 3, Health Canada will require far fewer trial participants due to the data already collected from approved vaccines.
“In that situation, it would be much quicker,” he said.
With proper funding for the clinical trials and manufacturing, Lewis said the vaccine could be ready for Canadians by the end of this year.
However, a lack of funding continues to be a barrier and is also a source of frustration for Lewis, whose company shifted its focus at the start of the pandemic from developing cancer gene therapies to using its Fusogenix drug-delivery platform to develop a COVID-19 vaccine.