INO Inovio Pharmaceuticals Inc New

By Betsy McKay and Peter Loftus 

International health officials vowed after West Africa's Ebola crisis to be better armed for the next epidemic with vaccines, drugs and diagnostic tests.

Now the next one--Zika--is here and in an echo of Ebola, researchers are scrambling to develop medical tools to fight the virus.

About 15 companies are working on Zika vaccines, most in the initial stages, according to the World Health Organization.

Among the more advanced are some in development by the U.S. National Institute of Allergy and Infectious Diseases and Bharat Biotech International Pvt. Ltd. in India, said Marie-Paule Kieny, the WHO's assistant director-general for health systems and innovation. She predicted it would take at least 18 months for large-scale trials to get under way.

Drugmakers Sanofi SA, Inovio Pharmaceuticals Inc. and NewLink Genetics Corp. say they are now developing Zika vaccines. The NIAID and the Scripps Research Institute are searching for potential drugs, while companies including Chembio Diagnostics Inc. are working on new diagnostic tests.

In some ways, the efforts are even further behind than they were with Ebola--for which there is still no licensed drug or vaccine. At least a dozen Ebola vaccine and drug candidates were already in development when the virus spread in West Africa in 2014. There were no products in advanced development for Zika, which had been considered a low-level threat before serious complications emerged in the second half of last year in Brazil.

Under the best-case scenario, it will take until roughly the end of 2017 to gather enough data from trials for regulators to make a decision on one of NIAID's two candidate Zika vaccines, institute director Anthony Fauci said in an interview.

Still, scientists are confident that despite the late start, they may be able to at least shorten normal development timelines, which can take a decade or more, by harnessing past research on similar viruses such as dengue. Some companies and the NIAID are trying to tweak existing designs they have already developed for vaccines against similar viruses.

"I think we're going to see a very robust field of vaccines coming forward," said Dr. Fauci, adding that he spoke with "at least two major companies" on a recent weekend.

The scramble to slow the spread of Zika points to a larger problem: Epidemics move faster than global institutions. There are no vaccines for many of the world's largest health threats in part because it isn't a very lucrative business. Epidemics are unpredictable, making for an uncertain revenue stream, and often erupt in poor parts of the world. Health officials are aware that current research and development processes are ill-suited for epidemic diseases and have begun working on changes in the wake of the Ebola crisis.

Testing on the effectiveness of medical products for Ebola didn't get under way until the epidemic was tapering off. One vaccine, developed by Merck & Co. and NewLink, was shown to be effective in a clinical trial. The NIAID halted a trial on a drug called ZMapp because there weren't enough Ebola patients to determine conclusively how well the drug worked.

Other challenges in the case of Zika include a dearth of prior research on the mosquito-borne virus; difficulties developing drugs to ease an infection that has short-lived symptoms; and possible cross reactions with related viruses like dengue.

Sanofi said last month it started work on a Zika vaccine, using 20 years of expertise from developing a vaccine against dengue, which is in the same family of viruses. "We aim to cut years off the normal timelines," a Sanofi spokeswoman said.

The NIAID also is taking advantage of earlier research, modifying products that already were in development, Dr. Fauci said. It is inserting a gene for Zika virus into a vaccine originally developed for West Nile virus, for which the institute couldn't find a commercial partner. NIAID hopes to start human clinical trials on the Zika vaccine candidate in September in the U.S., Dr. Fauci said.

Inovio Pharmaceuticals hadn't done any Zika research before last year. But after reading about the spread of Zika in South America, Chief Executive Joseph Kim decided to try making a Zika vaccine with the same technology it is using to develop vaccines against other diseases, based on DNA sequences found in the targeted viruses.

That initial, small-scale effort took on new urgency earlier this winter after Dr. Kim started seeing photos of babies born with microcephaly--undersized skulls and brains--which researchers have tied to Zika infections in the mothers.

"As a father of three young kids, it definitely moved me personally," Dr. Kim said in an interview.

The company plans to test its vaccine in monkeys infected with Zika, and, if successful, move into human testing possibly by early next year, he said.

Development of drugs has drawn less interest; Zika causes mostly mild, short-lived symptoms, and 80% of those infected never develop symptoms. The Scripps Research Institute is one of the few that is searching for potential treatments, using a robot at a lab in Jupiter Beach, Fla., that can perform test-tube screening of millions of chemical compounds. Researchers inject a glowing substance called luciferase--also found in fireflies--into modified Zika cells to help show whether a potential drug candidate is halting replication of the virus.

It will take at least two years to find a treatment, predicted Michael Farzan, a professor of immunology and microbial science at Scripps.

Researchers and companies also are working on faster and more accurate diagnostic tests, as demand for testing grows. Current tests are run only in advanced laboratories, and have limitations. Tests for antibodies don't always distinguish between recent infection with Zika and related viruses such as dengue. A second, confirmatory test is required.

The Centers for Disease Control and Prevention said it has been receiving hundreds of tests a day to process. It is now distributing that test package to other qualified labs to ease the backlog.

Chembio Diagnostic Systems Inc. is working on a portable, rapid-results Zika test. It aims to show from a drop of blood from a fingertip whether someone is infected, said Chief Executive John Sperzel. He predicted the company could develop a prototype by midyear, and then test its accuracy in the field. "We need to quickly develop rapid, point-of-care tests that are simple, cost-effective and portable," he said.

Write to Betsy McKay at betsy.mckay@wsj.com and Peter Loftus at peter.loftus@wsj.com

(END) Dow Jones Newswires

March 06, 2016 19:28 ET (00:28 GMT)

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