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 worldâ€™s growing vaccine stockpiles farther, protecting more people faster.
And itâ€™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.
Thatâ€™s big news at Gaithersburg, MD-based Iomai, which has also reported success advancing a patch for travelerâ€™s diarrhea through mid-stage trials.
â€œThe problem here is that we donâ€™t have any way to respond to a pandemic right now,â€ says Dr. Gregory Glenn, chief scientific officer at Iomai. And thereâ€™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 hasnâ€™t been greeted with instantaneous applause from his peers.
â€œThe scientists and I had a good laugh,â€ says Glenn. â€œThey 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.â€
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 isnâ€™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 travelerâ€™s diarrhea, which is nearing late-stage trials.
â€œThe dose is different but the rest of the technology and all the work behind these things weâ€™ve done for the travelerâ€™s product,â€ says Glenn.
That earlier work helped persuade Health and Human Services to give Iomai a $128 million contract to develop the patch, putting the â€œlittle community college football playerâ€ in the same league that has fielded development teams from giants like GlaxoSmithKline and Novartis.
Iomai has already posted positive mid-stage data on travelerâ€™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 Iomaiâ€™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 travelerâ€™s diarrhea end up as irritable bowel syndrome, says Glenn.
Due to the unique nature of the product itâ€™s developing, Iomai CEO Stanley Erck and the executive team at Iomai decided that it was in the developerâ€™s best interest to build their own manufacturing facility. Now Glenn says they have the capacity to begin production for an approved product.
â€œWe have a manufacturing facility -- an independent, functional unit â€“ which is very attractive to an outside partner,â€ says Glenn. â€œSo weâ€™re definitely looking for a partner for travelerâ€™s diarrhea.â€
Iomai has the only biologic/patch-making facility in the world, says Glenn. â€œWe did one round of outside contract manufacturing and it convinced us we needed to do it ourselves. When itâ€™s your own product, youâ€™re a lot harder on yourselves in terms of quality.â€
In most cases, Phase I/II data would be a preliminary step toward a long stretch of testing ahead. But normal development timelines donâ€™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 hasnâ€™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 travelerâ€™s diarrhea, there are further programs to develop.
â€œWeâ€™ve done a little clinical work with a needle-free flu patch, and that has a very attractive market,â€ says Glenn. â€œSo weâ€™re working on that also. There are also a couple of other programs we havenâ€™t disclosed. We have a robust pipeline and we have things at different stages we havenâ€™t disclosed.â€
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.
â€œEveryone here would like to make an impact,â€ sums up Glenn.