Crocodiles, sharks and bears are considered among the most deadliest animals on earth.

But as far as Hawaii Biotech Inc. is concerned, public enemy No. 1 is the mosquito, which carries the Zika virus that has terrorized the world with its ability to cause serious birth defects during pregnancy.

“It’s been said that to the human, the mosquito is the most dangerous animal on the planet for just this reason — mosquitoes can transmit a lot of viral diseases, as well as parasite disease like malaria,” said Hawaii Biotech CEO Elliot Parks, whose company is among several that are developing a vaccine for the potentially deadly virus. “Mosquitoes can easily transmit disease into your bloodstream. So there are a lot of mosquito-borne infections, especially where there are mosquitoes, which of course are in the tropics and in the semitropics.”

Critical timing

This isn’t the first time that Hawaii Biotech has taken aim at the Aedes aegypti mosquito, which also carries the dengue and chikungunya viruses. But there’s no question that the timing now is of the utmost importance since Zika can cause severe fetal brain defects and be passed through sex from a person who has the virus to his or her partners.

The Zika virus gained a lot of attention during the Rio Olympics because many athletes dropped out of the competition for fear of contracting or passing on the disease.

In Hawaii there have been eight travel-associated cases this year, according to the state Department of Health. There have been no locally transmitted cases.

On Jan. 15 Hawaii had one of the first reported births in the U.S. of a baby with microcephaly, whose mother — previously from Brazil — was confirmed with Zika. Microcephaly is a birth defect in which a baby’s head is smaller than expected when compared with babies of the same sex or age — an indication that the brain has not developed properly. The failure of the brain to develop fully can lead to many other problems, including seizures, intellectual disability, troubles with movement and balance, feeding problems, hearing loss and vision problems.

Nationwide there have been 2,722 Zika cases — with 2,686 of those associated with travel — from Jan. 1, 2015, through Aug. 31 of this year, according to the Centers for Disease Control and Prevention. In addition, there have been 14,110 cases in U.S. territories — more than 98 percent of those in Puerto Rico — through the same period. Puerto Rico is the so-called ground zero for Zika because its warm, wet climate makes it ideal for the kind of mosquito that spreads the disease, its poor economy has left abandoned houses that are breeding grounds for the insects, and the established insecticides used in the past have been met with widespread resistance among the mosquitoes.

Safety is ‘major issue’

“We’re one of several companies that are making different types of Zika vaccines to see which one is best and which one works best,” Parks said last week at the company’s new headquarters at Dole Cannery.

“We’re competitive because we feel our vaccine is exceedingly safe, and safety is a major issue with Zika.”

Parks said one reason Hawaii Biotech’s vaccine is safe is because the company doesn’t use the live virus in its vaccine, but rather uses proteins from the outside of the virus.

“That’s part of our secret sauce,” Parks said. “Proteins are much easier to identify that they’re safe because you’re not talking about a virus, not a live organism that replicates.”

According to the CDC, a live vaccine causing a full-blown disease is extremely unlikely, but it did happen in the case of the live oral polio vaccine. “This was a rare, but tragic, side effect of this otherwise effective vaccine,” the CDC said on its website, adding that the oral polio vaccine is no longer used in the U.S.

Parks said giving a viral vaccine, especially to pregnant women, is a risky proposition because of potential side effects.

“Giving them a nonreplicating protein vaccine is intrinsically safer,” he said.

There is currently no vaccine or treatment for Zika. The most common symptoms of the virus are fever, rash, joint pain and red eyes.

“I’m sure there will be some sort of Zika vaccine in the clinic (trials) between now and the end of the year worldwide,” Parks said. “Our vaccine won’t be in the clinic until early next year.”

For a vaccine to be approved, it must go through three phases of human clinical trials reviewed by the U.S. Food and Drug Administration and other regulatory agencies.

“Safety is always the issue, and no agency is ever going to approve a vaccine that it doesn’t think is safe,” Parks said. “Some vaccines take much longer than others to prove that they’re safe to the regulators’ satisfaction.”

Hawaii Biotech, which has about 20 employees, has no commercial products on the market and survives through grants and contracts it receives to conduct research. The company has two parts: one that develops vaccines for infectious diseases and another that develops antitoxin drugs for biological threats.

“In the vaccine business you have to be in the right place at the right time, which is why we’ve moved so rapidly to try to develop the Zika vaccine,” Parks said. “We have a variety of vaccines that we’re developing for potential emerging diseases, but if those diseases don’t emerge as rapidly as we think, then they are more of an academic interest than a commercial interest.”

Shift in funding

Hawaii Biotech, which was founded in 1982, soon will be moving to new laboratories at Dole Cannery after being located in Aiea since 1983 in the former Sugar Planters Association building. The company has a temporary lab on Young Street.

The company raised more than $30 million in equity financing from early investors, mostly during the state’s Act 221 era, before switching funding strategies after 2008. Act 221 provided a tax credit to investors in Hawaii high-tech companies. That program ended in 2010.

Hawaii Biotech also has been awarded more than $60 million in grant and contract funding since its inception, and currently receives about $6 million annually in such funding. The company hasn’t relied on equity funding for eight years.

“In the last 30 years, Hawaii Biotech has evolved along with the funding sources,” said Parks, who has been with the company since 2008. “We have changed our strategies and we work on grant and contract revenue, and we have a very healthy backlog in grants and contracts.”

Full plate of projects

Hawaii Biotech filed for Chapter 11 reorganization in December 2009 after a shareholder dispute blocked venture capital financing. In July 2010 drug giant Merck & Co. purchased Hawaii Biotech’s dengue vaccine research unit, giving the local company the capital it needed to come out of bankruptcy. Hawaii Biotech emerged from reorganization in June 2011.

Even though Hawaii Biotech is no longer involved with the dengue vaccine, it has a full plate in developing vaccines for Zika, chikungunya, West Nile, tick-borne flavivirus, malaria, Crimean-Congo hemorrhagic fever and Ebola.

“There’s tremendous interest in Zika, but right now West Nile has gone further in the clinic than we’ve gone with Zika,” Parks said. “West Nile and Zika are both neuro-invasive (capable of infecting the nervous system), but Zika also causes these birth defects and therefore there’s a lot of public interest in Zika right now.”

Hawaii Biotech also is developing biodefense drugs to treat bioterrorism agents, such as anthrax and botulinum.

“We have programs that are funded by the federal government to develop small-molecule drugs … that block the toxins — the anthrax toxin and the botulinum toxin,” Parks said. “The concept is instead of more elaborate or difficult therapies in case of an attack, our concept is what’s been called a pill in a pocket. We want first responders and anyone else who might potentially be exposed to have a pill that can be distributed that they can take easily. Pills, of course, are easy to transport. They store very well, and they have a long shelf life.”

Hawaii Biotech, under then-CEO David Watumull, used to be involved with developing the Cardax anti-inflammatory product. But that portion of the company was spun off 10 years ago with Watumull accompanying the spinoff company, which is now publicly traded.

Parks said it remains to be seen whether Hawaii Biotech will end up pursuing the initial public offering route to provide an investment return to its investors.

“The liquidity for our investors would be either going public, selling the company or partnering individual products, and we continue to look at all three of those,” he said. “We’re clearly interested in returning their investment. Those are the three legs of that liquidity stool, and we haven’t closed off any of them.”