New front launched in war on malaria

With a $29.3 million grant from the Gates Foundation, Rockville company opens manufacturing plant

The plant was made possible largely by a $29.3 million grant in December from the Bill & Melinda Gates Foundation, plus $3.5 million in federal small-business grants captured in April for additional research. Co-hosting the opening was Sanaria’s partner, the PATH Malaria Vaccine Initiative in Bethesda. The initiative is part of PATH, a nonprofit health initiative headquartered in Seattle whose name formerly was Program for Appropriate Technology in Health.

Although researchers in dozens of laboratories around the world are trying to develop a malaria vaccine, Sanaria’s process is unique, Hoffman said. It is made of a suspension of the malaria-causing parasite that has been rendered harmless by a quick zap of radiation.

For 18 years, Hoffman, as director of the malaria vaccine program at the Naval Medical Research Center in Silver Spring, worked on making a malaria vaccine through DNA recombinant technology, he said. There is still no effective vaccine for the disease today.

Hoffman, a physician, said that following his Navy career and a short stop as a researcher at Celera Genomics Inc. in Rockville, he and his son Alexander, home between college and law school, sat down to talk about how to build a business around a single idea and an enormous need. Malaria kills more than 2 million people a year, according to the World Health Organization.

‘‘When I left Celera in July 2002 and started Sanaria in my breakfast room, there were 3,000 children a day dying of malaria — one every 30 seconds,” Hoffman said. ‘‘Now, five years later, there are still 3,000 children dying a day of malaria. Our goal was to start a vaccine program to eliminate those deaths.”

Hoffman said the current vaccine project was the only viable approach. While in the Navy, he had experimented with such a vaccine and published results of its effectiveness on volunteers.

Sanaria began producing small lots of the vaccine at its initial location in east Rockville last year after several years of preparation.

For the past six months, the company has been building the new, bigger plant in west Rockville.

Sanaria has added about a dozen employees. Next, it will use a few hundred lab workers to carefully extract the irradiated parasites from the salivary glands of mosquitoes. Hoffman hopes that each mosquito will provide two or three doses of the vaccine.

Hoffman expects the vaccine to be 90 percent effective in eradicating malaria. Having shown that the vaccine can be manufactured under best manufacturing practices, the partnership will now launch clinical trials to determine effectiveness, dosage levels and the best way to administer it.

Hoffman’s wife, B. Kim Lee Sim, vice president for process development and manufacturing, led a team that worked for four months to develop the methods and lots used in pre-clinical tests.

‘He has continuallyovercome every obstacle’

Anthony Fauci, director of the National Institute of Allergic and Infectious Diseases of the National Institutes of Health, has high hopes for Hoffman and the vaccine.

‘‘The NIH, my institute, over the past several years has given a number of grants to Steve to help him develop the fundamental concept of this new approach toward a malaria vaccine ... and he has continually overcome every obstacle toward this approach, technical and logistical obstacles,” Fauci told The Gazette earlier this year.

‘‘And then he needed a considerable amount of money to get the clinical trials going to make the product in a way that you can inject it into people and also to actually do the clinical trials,” Fauci said. ‘‘The Gates money came at the right time to get those trials started. He needed to get a plant started to make the product and use it to do the trials.”

The plant represents a major milestone in the effort to translate Sanaria’s approach into a ‘‘safe, highly efficacious vaccine,” said Christian Loucq, director of the PATH malaria vaccine program, in a statement.

The Oct. 26 ceremony, attended by politicians and ambassadors from Africa, among others, was to celebrate the hard work and long hours of Hoffman’s 40 employees and Sanaria’s partners. ‘‘It is an honor to work with these people,” Hoffman said.

His colleagues in the vaccine field initially thought his idea was crazy because not enough vaccine could be produced, he said. ‘‘Now we have the vaccine in the bottle and the manufacturing plant up to standards.”

From babies to soldiers

The company plans to file for a new investigative drug application for the vaccine to the U.S. Food and Drug Administration in August. Clinical trials will take several years and the goal is to get the vaccine to those who need it in about five years.

Sanaria is targeting four main markets. Most in need are the 25 million African infants who are exposed to the disease. The second group is the millions of pregnant women and girls in Africa. Hoffman said they lose part of their immunity to malaria when they become pregnant, leading to more miscarriages and lower-weight newborns.

The third group is the millions of travelers who visit regions where malaria is rampant and who would be willing to pay a significant price for the vaccine. These revenues will help subsidize lower prices for poorer people, Hoffman said.

The fourth market is the military.

Once the vaccine is in all four markets, ‘‘you would expect to double or triple the sales in undefined markets around the world,” Hoffman said.

This report originally appeared in The Business Gazette.