San Diego Business Journal

Arcturus Therapeutics Inc. received the green light to begin Phase 1/2 clinical trials for its vaccine candidate, LUNAR-COV19, and signals an exciting development for the potential of an RNA-based COVID-19 vaccine.

The La Jolla-based company partnered with Duke-NUS Medical School in Singapore to develop a coronavirus vaccine and the move into Phases 1/2 clinical trials means the dosing of the vaccine for humans will be tested in the coming months.

“Arcturus is moving faster than ever to develop a solution to the coronavirus pandemic and this approval by the Health Sciences Authority — Singapore’s governing body of health regulations — opens the door for more opportunities to distribute a potential vaccine,” said Chief Executive Officer and President Joe Payne.

“Usually a program from inception to injection takes about two to three years, so to do something like this in five months is just an incredible process,” Payne said.

“It speaks to the technology and the type of vaccine that this is because it’s very simple,” Payne said. “Even though it’s a very sophisticated and elegant vaccine, it’s a beautifully simple vaccine as well. There’s no viruses associated with this vaccine as well; there’s no viral vectors that are delivering the technology or the vaccine, so we use a nonviral delivery technology.”

This type of experimental messenger RNA vaccine provides genetic material that would allow the body to make its own medicine to fight off the virus.

Professor Ooi Eng Eong at Duke-NUS in Singapore said in a July 21 statement that the preclinical data for the Arcturus vaccine candidate shows positive signs of becoming a potential commercial vaccine.

“Preclinical studies on LUNAR-COV19 have shown very promising findings, including the possibility that a single dose of this vaccine may be sufficient to trigger robust and durable immune responses against SARS-CoV-2,” said Professor Ooi Eng Eong, deputy director of the Emerging Infectious Diseases Program at Duke-NUS.

According to the Milken Institute, an independent, economic think-tank, Arcturus’ LUNAR-COV19 vaccine is among 27 RNA-based vaccines in development to combat the coronavirus pandemic.

“You have Moderna and Pfizer with successful messenger RNA programs that have just initiated phase 3 trials and they are doing very well,” Payne said. “They are proving the concept that messenger RNA vaccines can zero convert and build antibodies in human beings which is exciting. But, we’re different because we use a self-replicating messenger RNA.”

The self-replicating feature of the Arcturus vaccine candidate is derived from the company’s proprietary LUNAR technology that has the potential for a low-dose, single injection vaccine, Payne explained.

“Ours is a very scalable, manufacturable technology and the reason why is because it’s a beautifully simple vaccine and it works at an extraordinarily low dose,” Payne said.

The seven-year-old biotech also struck a manufacturing deal with Catalent, alongside pharmaceutical giant, Johnson & Johnson, to produce potential COVID-19 vaccines.

What’s more, the company recently announced a partnership with the Israeli Ministry of Health to supply the Company’s COVID-19 vaccine candidate, LUNAR-COV19. Payne said that the main reasons the Israeli government decided to do a deal with Arcturus is because its vaccine candidate was a great option from a financial and scientific standpoint.

“The science team likes the potential for safety, which means reduced incidence of injection site reactions because of the low-dose. They were also attracted to the self-replicating aspect which means it lasts longer and they like the durability of the vaccine,” Payne said. “The finance guys liked us as the potential best vaccine because of a single shot potentially, and that saves the finance group that does the budget a lot of money.”

Beyond its potential COVID-19 vaccine, Arcturus Therapeutics continues to push forward with its development of RNA medicines. The company announced on July 29 a public offering of about 3 million shares of its common stock at a price of $53.per share.

The company said in a press release that it, “intends to use the net proceeds of the offering to develop, test and manufacture the Company’s LUNAR-COV19 vaccine candidate and to continue clinical development of LUNAR-OTC; to advance the Company’s LUNAR-CF, LUNAR-CV and LUNAR-FLU preclinical programs into clinical development; to fund early research and development of novel and proprietary RNA medicines; and for general corporate and working capital purposes.”