Emerging Drug Developer: Iomai

Little Iomai comes up with a potentially big hit for bird flu

In the scramble to come up with new vaccines that could protect populations from a potential human outbreak, scientists have frequently cited the need for an adjuvant that could boost the effectiveness of a bird flu jab. An effective adjuvant would stretch the world’s growing vaccine stockpiles farther, protecting more people faster.

And it’s in that adjuvant niche that Iomai has just scored a direct hit.

In a Phase I/II trial, three out of every four people in the study of 500 people using the patch achieved a protective immune response after a single dose. That compares to 49 percent who achieved a protective response after a single, unsupported dose of vaccine. The currently approved H5N1 vaccine requires two doses on its own to become fully effective.

That’s big news at Gaithersburg, MD-based Iomai, which has also reported success advancing a patch for traveler’s diarrhea through mid-stage trials.

“The problem here is that we don’t have any way to respond to a pandemic right now,” says Dr. Gregory Glenn, chief scientific officer at Iomai. And there’s an urgent need to establish a mode of vaccinations in the event a human outbreak occurs.

The trial report marks a particularly sweet moment for Glenn, whose early work in vaccine and adjuvant research at the Walter Reed Army Institute of Research later developed into the patch technology advanced at Iomai. And every new insight of his hasn’t been greeted with instantaneous applause from his peers.

“The scientists and I had a good laugh,” says Glenn. “They were recalling when I first came up with the idea. They laughed at me, said it was crazy, using a patch on the skin to get improved immune response to a selected vaccine.”

The patch Iomai developed activates the skin immune system with a potent adjuvant that would be too strong to use by any other route of administration, he explains. The adjuvant isn’t absorbed in skin, but taken up by immune cells.

In the trial, volunteers were given a dose of a bird flu vaccine developed by Solvay. But the data indicates that the adjuvant would work with any bird flu vaccine, giving it some big-market versatility. The company is working with the same adjuvant it has developed for traveler’s diarrhea, which is nearing late-stage trials.

“The dose is different but the rest of the technology and all the work behind these things we’ve done for the traveler’s product,” says Glenn.

That earlier work helped persuade Health and Human Services to give Iomai a $128 million contract to develop the patch, putting the “little community college football player” in the same league that has fielded development teams from giants like GlaxoSmithKline and Novartis.

Iomai has already posted positive mid-stage data on traveler’s diarrhea. Now a late-stage study is being planned with travelers to Guatemala and Mexico in the summer of 2009. Last year a trial demonstrated that Iomai’s vaccine for diarrhea produced a 75 percent reduction in moderate to severe diarrhea. And interim data from a follow-up study shows that relying on travelers to administer the second dose through a self-applied patch was also effective, eliminating a follow-up trip to a clinic for a second dose. Almost a third of all bouts of traveler’s diarrhea end up as irritable bowel syndrome, says Glenn.

Due to the unique nature of the product it’s developing, Iomai CEO Stanley Erck and the executive team at Iomai decided that it was in the developer’s best interest to build their own manufacturing facility. Now Glenn says they have the capacity to begin production for an approved product.

“We have a manufacturing facility -- an independent, functional unit – which is very attractive to an outside partner,” says Glenn. “So we’re definitely looking for a partner for traveler’s diarrhea.”

Iomai has the only biologic/patch-making facility in the world, says Glenn. “We did one round of outside contract manufacturing and it convinced us we needed to do it ourselves. When it’s your own product, you’re a lot harder on yourselves in terms of quality.”

In most cases, Phase I/II data would be a preliminary step toward a long stretch of testing ahead. But normal development timelines don’t apply to pandemic products. Glenn notes that an early approval for a pandemic patch could follow two new mid-stage trials. And a contract to supply U.S. stockpiles could be swiftly followed with orders from concerned governments around the world.

The recent news about bird flu hasn’t been good. In recent weeks the U.N. has raised fears that the endemic presence of the bird flu virus in Indonesia significantly raises the possibility of a human outbreak.

If Iomai is successful with bird flu and traveler’s diarrhea, there are further programs to develop.

“We’ve done a little clinical work with a needle-free flu patch, and that has a very attractive market,” says Glenn. “So we’re working on that also. There are also a couple of other programs we haven’t disclosed. We have a robust pipeline and we have things at different stages we haven’t disclosed.”

For a drug developer, any successful program is supremely satisfying, notes Glenn. But any developer able to make an impact in the area of pandemic therapies is in a position to save a multitude of lives.

“Everyone here would like to make an impact,” sums up Glenn.