US company to test COVID-19 vaccine by August

If trial proceeds as expected, vaccine will be among the first to test on humans

A California company with Israeli roots said its animal studies of a potential novel coronavirus vaccine are so promising that they believe they can begin testing the vaccine on humans as early as August.

The first batch of the vaccine was shipped to Singapore’s Duke-NUS Medical School last week, where a Phase 1/2 clinical trial is meant to take place and test the safety, side effects and best dose of the new vaccine. If the trial proceeds as expected, the vaccine will be the first of its kind to get this far.

According to Joseph Payne, founder and CEO of Arcturus, Lunar-COV19 (the name for the vaccine) utilizes the company’s self-transcribing and replicating mRNA (STARR) technology and its LUNAR lipid-mediated delivery to produce a low-dose, potential single-shot vaccine.

It is being researched and developed together with a team of scientists at Duke-NUS who have worked on coronaviruses in the past, including Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS).

Messenger RNA (mRNA), a genetic material, is being used by the company to trigger an immune response in the body. Once the mRNA is injected, the vaccine prompts the body to make proteins like those of the actual virus, which the body then recognizes and learns to fight them off.

So far, Payne told The Jerusalem Post, the company achieved a 100% success rate in animal trials on mice, rats, rabbits and pigs, showing that the vaccine is effectively activating the two fundamentally important components of the adaptive immune response: humoral (antibodies) and cellular (T-cells) immunity. Since the results were published, Arcturus’ market value skyrocketed from $50 million to around $1 billion.

Payne said the big differentiator between his company’s vaccine and others in development is that it requires only one dose because of its replicating effect. Most others (including the one being tested by Moderna) require two doses, an initial injection and a booster shot.

“We are cautiously excited because if we can reproduce this in human beings – and at this point there is no reason to think we won’t – then we have a single administration vaccine,” Payne said.

The vaccine does not contain any viral material or adjuvants, nor does it contain antibiotics, dangerous ingredients or preservatives, material provided by the company’s spokesperson explained. Payne said the Phase 1/2 clinical trial is expected to include 108 participants, including elderly. They will test the one microgram dose and much higher doses to help to prove its safety.

Arcturus has been in the vaccine space for several years. It has close ties with Israel in that it merged with Israel’s Alcobara Ltd. in 2017. There are still a handful of Israelis working among the company’s staff of 120 people.

Dr. Rodrigo Yelin, who made aliyah to Israel when he was 17 and was trained at Hebrew University before working in the country’s biotech space, joined Arcturus about a year-and-ahalf ago. Now, he is serving as the company’s senior program manager for the LUNA-COV19 vaccine.

He described the company as “multicultural” and said that employees come from around 25 countries, including Lebanon, Iran, Japan, Italy and Spain.

The research and development of the vaccine is being funded in part by the government of Singapore, Payne said. But he noted that the company held a successful funding round in April and secured support from several key investors, “so we are in good shape.”

He said the Singapore funding requires that if a successful vaccine is developed that country will receive it first. But with only 5 million people, he believes there will be more than enough to go around. His spokesperson said that Arcturus is willing to give Israel precedence regarding access to the vaccine.

In mid-June, Israel signed with Moderna for the purchase of its mRNA-1373 vaccine should the company succeed in its development.

Assuming Arcturus completes the development of the vaccine by the end of 2020, there are still many outstanding questions, such as how much and how quickly they can manufacture and which countries outside of Singapore will approve its use.

In May, Arcturus signed an agreement with Catalent Inc., a Wisconsin-based company, to support the expected manufacturing of its COVID-19 mRNA vaccine. Catalent is supporting the manufacturing of the vaccine for the company’s clinical studies now.

Payne said that depending on required dose size, he expects to manufacture enough of the vaccine to treat 3 million to 30 million people in the first round.

Of course, Arcturus is far from the only company working toward a coronavirus vaccine. The New York Times’ vaccine tracker shows that there are close to 150 vaccines against coronavirus in development, of which more than a dozen are being tested in Phase 1 and phase 2 clinical trials. Three are in Phase 3.

And they are many months away from a vaccine being on the market. Payne made clear that the regulatory approval is “outside of our control.” He said he is first hoping to achieve FDA Emergency Use Authorization.