Arcturus Therapeutics’ CEO Joseph Payne is making the media rounds. He’s got an attention-grabbing sales pitch, a single shot, very low-dose potential COVID-19 vaccine, for which the company has shared a comprehensive suite of pre-clinical data.

Some see the “ideal vaccine” as one that invokes production of neutralizing antibodies, increases the amount of T-cells, CD-8 cells in particular, and one that does not produce other antibodies that have nothing to do with the neutralizing process.

Immune Response

“You want the desired immune response, but don’t want to invoke the undesired immune response,” said CEO Payne.

Finding the Dose

Currently, Arcturus’ mRNA vaccine is in phase 1 trials in Singapore to determine what the appropriate dose of the vaccine would be for humans, Payne said. Once the dose is determined, the vaccine can embark on large clinical trial in Singapore or outside of it at multiple sites.

Ultimately, it will be up to Singapore’s Health Sciences Authority to determine when to initiate next trials, Payne said.

Early in March, Arcturus and Duke-NUS Medical School in Singapore announced a partnership to pursue a COVID-19 vaccine.

Manufacturing

Recently, Arcturus announced a manufacturing deal with Catalent.

“We chose each other,” said CEO Payne. “Catalent is one of the leaders, if not the leader, in manufacturing biologics of different sorts.”

J&J, the No.1 pharma company in the world, is also using Catalent to assist with significant manufacturing campaign

“We are happy to partner with someone who has efficiency, capability and confidence to endeavor toward these large manufacturing campaigns,” Payne said.

“I’m sure they will explore other vaccines as well. We are happy to be working with Catalent to increase our capacity in case our paths lead in that direction, and so far all the data we have collected and the path we are on suggests that we are going in that direction.”

Arcturus’ single shot, low dose vaccine looks to capitalize on those attributes for a potentially big edge in manufacturing.

Pricing Models

There are different types of pricing models for vaccines, according to Arcturus. It starts with rights and access to (unapproved) vaccine and there are pricing models for that. Then, as we build out and manufacture the vaccine — and it is still not approved — there is stockpiling initiative, and there is pricing associated with that. Then, once we get regulatory approval, we have post-approval commercial pricing, more traditional pricing that you would normally see in a non-pandemic environment.

“We have not disclosed our confidential discussions with different entities, not just countries but various government agencies here and abroad and potential strategic partners, large pharma partners that could help us.

“We got a great vaccine we’re looking for others to help us,” Payne said. “We are looking to get regulatory agencies to approve our vaccine as soon as reasonably possible.”

According to Arcturus, its data and single shot may mean a shorter development timeline.

There are about 100 to 150 vaccines being worked on.

“To be in the Top 10 for us is a reasonable goal,” Payne said. “There is no way 10 companies can supply global demand in short amount of time. Collectively, the first 10, 20 to 30 vaccines approved will play a role in vaccinating the planet.”

‘Sophisticated and Elegant’

Payne said even though mRNA vaccines are sophisticated and elegant, they are also simple, completely devoid of any virus element which makes them safer. Some vaccines use other agents which add other variables which need to evaluated in long-term safety trials.

Delivery System

“The Arcturus vaccine is a self-replicating messenger RNA which lasts for two to three weeks instead of two to three days, and that is why the technology potentially negates the need for a second shot and allows it to be single shot,” Payne said. “You couple that with company’s LUNAR delivery platform which is intended to effectively deliver this large mRNA molecule into the cells of your body where it can develop the full length spike protein of the coronavirus. So if you didn’t have the delivery technology, the mRNA molecule would be useless because you wouldn’t be able to get it into the cell and do what it is supposed to do, build the full length spike protein and invoke the proper immune response. You need a safe and effective delivery system, and we believe we have one of the world’s best, if not the best, delivery technology.”

According to the Arcturus, LUNAR is designed to be biodegradable; the lipids don’t just sit in your arm. It makes it easier that the amount of mRNA and lipids is small to begin with. Based on pre-clinical evaluation in animals, the company doesn’t expect any side effects.