Iomai

Intercell snaps up Iomai in $189M deal

Tue, 13 May 2008 06:59:57 -0400

The little Maryland-based vaccine developer Iomai, which has posted some impressive data on a new therapy for traveler's diarrhea as well as an adjuvant for bird flu vaccines, is being bought out by Intercell for about $189 million. Intercell gains a mid-to-late-stage product in the needle-free diarrhea program, adding it to a Japanese encephalitis vaccine it has in development. The diarrhea patch is scheduled to enter Phase III in the first half of 2009. Intercell is looking for approvals of its vaccine by regulators around the globe this year.

In the deal, Iomai's public investors get cash for their shares while a group of large stakeholders will exchange their Iomai shares for shares in Intercell. Iomai was featured as one of FierceBiotech's emerging drug developers.

- here's the release
- read the AP story

Feds ok Iomai Phase II adjuvant patch study

Wed, 16 Apr 2008 06:59:54 -0400

Health and Human Services is giving Iomai the green light to do a mid-stage dose ranging study of its adjuvant patch for bird flu vaccine. HHS provided a $128 million contract backing Iomai's effort last year, and was rewarded with dramatic Phase I/II data on its ability to boost the effectiveness of bird flu vaccine.

The U.S. government, like other governments around the world, has been stockpiling vaccine to fight a potential pandemic. Iomai's patch worked well enough to provide protection to many people after a single dose, rather than the two usually required. That would allow physicians to stretch available vaccines over a much larger population on a much quicker basis.

"The Iomai immunostimulant patch has the potential to change how we react to an influenza pandemic, and we will move ahead quickly with the development of this technology," said Iomai CEO Stanley C. Erck. "Based on the data from this new Phase II study, Iomai and HHS will evaluate whether to proceed next with a pivotal Phase III trial."

- here's the press release

ALSO: South Korea has mobilized troops to help fight the spread of H5N1 in poultry. Report

Related Articles:
Emerging Drug Developer: Iomai. Report
Iomai gets boost in bird flu vaccine adjuvant study. Vaccine report
Iomai vax patch guards against traveler's diarrhea. Iomai report
Vaccine-maker Iomai files $83M IPO. Report

ALSO NOTED: Dendreon shares jump on investment deal; Iomai in pact with Merck; Foundation antes millions for MS leads; and much

Thu, 03 Apr 2008 07:59:50 -0400

> Schering-Plough has proven quick on the layoff trigger. The company announced a plan to cut costs by $1.5 billion by 2012 in the wake of the latest round of Vytorin controversy. Roughly 5,500 employees will lose their jobs, or about 10 percent of the company's workforce. Report

> Shares of Dendreon jumped seven percent on the news that an institutional investor will buy up 47 million in shares and warrants. That money is earmarked for Dendreon's prostate cancer drug Provenge and other drug candidates in its pipeline. Release

> Iomai has forged a deal with Merck to conduct proof-of-principle preclinical studies evaluating the use of the Iomai needle-free immunostimulant patch. Merck has first option to negotiate an exclusive license. These preclinical proof-of-principle studies will be conducted using an undisclosed Merck vaccine. Release

> The Myelin Repair Foundation has spent $10 million so far to identify 18 new drug leads for multiple sclerosis. Report

> Chutes & Ladders: Akers Biosciences has promoted Robert J. Paratore to chief financial officer. Report

> Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 percent of respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA. Report

> The U.K.'s National Health Service is spending around $3.9 billion annually to treat patients for adverse reactions to prescription drugs. Report

And Finally... A professor at the California Institute of Technology is walking away with the $1 million Gotham Prize for an original approach to killing cancer cells. Report

Emerging Drug Developer: Iomai

John Carroll — Mon, 24 Mar 2008 08:36:13 -0400

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.