Singapore-Arcturus coronavirus vaccine candidate on track for 2021 delivery

SINGAPORE — A Covid-19 vaccine candidate co-developed by Singapore scientists has shown positive interim results and could be available as early as 2021.

That’s according to American biopharmaceutical firm Arcturus Therapeutics, which is working with scientists from Duke-NUS Medical School in Singapore, to develop the vaccine.

Early this month, Arcturus announced positive interim clinical study results from its ongoing Phase 1/2 study of its vaccine candidate, ARCT-021.

“One of the unique advantages of the Arcturus vaccine is that it’s a low-dose vaccine, projected to be 7.5 micrograms, which is a much smaller dose than other vaccine prospects currently being evaluated,” Joseph Payne, President and CEO of Arcturus Therapeutics, told CNBC in an interview two weeks ago.

He highlighted that this could possibly yield more doses in each manufacturing run, that will in turn save time and money.

The vaccine is on track to be shipped in early 2021, Arcturus said in a press release.

Arcturus’s vaccine uses messenger RNA (mRNA) technology — a novel approach to vaccines which scientists hope will trigger the immune system to fight the virus. It is the same approach used by high-profile vaccine prospects of other American pharmaceutical companies Moderna and Pfizer.

The Arcturus vaccine can be delivered as a single or multiple-dose.

Other vaccine candidates from both Pfizer and Moderna require two doses to be effective.

“We believe that our vaccine candidate could be an important contribution to controlling the global COVID-19 pandemic,” said Steve Hughes, chief development officer of Arcturus in the release. “In the coming weeks, we expect to complete our discussions with regulatory authorities and we are working with urgency to advance ARCT-021 into later stage studies.”

The San Diego-based pharmaceutical firm and Duke-NUS Medical School received the go-ahead for clinical trials in July 2020. They proceeded with 106 participants between the ages of 21–80 years of age.

As of Nov. 9, 78 of those participants received at least one injection, while 36 subjects received two injections — or a prime boost, according to the biopharmaceutical firm. A prime boost vaccination involves an individual receiving multiple doses of the same vaccine.

The remaining participants, 28 of them, received a placebo dose. A placebo is a drug given to one group in clinical trials in place of the investigational vaccine, so that researchers can measure and compare how both groups respond.

There have been no serious adverse effects recorded so far in the trials, the CEO said.

Of the 78 participants, 77 developed positive results, which puts the trial on track for a Phase 3 implementation, Payne told CNBC.

Singapore’s Economic Development Board (EDB) has committed about $220 million to the Arcturus vaccine so far.

The government agency has invested $45 million to support the manufacturing process of ARCT-021 vaccine. The city-state has also committed an additional $175 million in preorders of the vaccine when it is ready.

Other countries are also in talks with Arcturus for potential vaccine purchases, including Israel, with a purchase agreement of up to $275 million.

Shipments are expected to begin in the first quarter of 2021. “Our manufacturing horizon is looking very promising. We’re in very good shape,” Payne said. “We have a manufacturing process that’s robust and scalable.”

Currently, Arcturus is working with regulatory agencies for approval, and will manufacture the vaccine in both the U.S. and Europe when it is approved. Leading pharmaceutical manufacturing organization Recipharm has recently come on board to manufacture the vaccine.