IOMAI IMMUNITY THAT'S MORE THAN SKIN DEEP

Iomai has three clinical and three preclinical programs in development::

Travelers' Diarrhea Vaccine:
Iomai is completing Phase 2 testing of a vaccine for travelers' diarrhea. A Phase 2 field trial found that the needle-free patch vaccine significantly cut the risk of moderate to severe travelers' diarrhea by 75 percent compared with a placebo patch, and the vaccine has been shown in Phase 1 and 2 studies to prompt a strong immune response to the bacteria that is the most common cause of travelers' diarrhea.

Immunostimulant Patch for Pandemic Influenza:
Iomai has begun clinical testing of an immunostimulant patch to be used in conjunction with vaccines for pandemic influenza. Such a patch, which uses an adjuvant designed to boost immune responses, would have the effect of expanding limited vaccine supplies by allowing public health officials to use fewer or lower doses of vaccine.

A Phase 1/2 clinical trial found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled with a single 50-microgram Iomai patch, was sufficient to provide an immune response considered protective in of those tested, a statistically significant improvement over those who received the H5N1 influenza vaccine alone. The trial is one of the first to demonstrate that a single dose of pandemic influenza vaccine may meet the level of protection suggested in U.S. Food and Drug Administration guidance.

Funding for this program has been supplied in part by a grant from the National Institutes of Health.

Immunostimulant Patch for Influenza Vaccination:
Only about half of all elderly patients who receive the influenza vaccine are protected, and Iomai is preparing to begin a Phase 2 study of an adjuvant-based patch that has been shown to boost vaccine response in the elderly.

Needle-Free Influenza Vaccine:
Iomai is developing a needle-free influenza vaccine patch that contains influenza antigens and is designed to compete with injectable vaccinations. We are now conducting preclinical testing to identify specific types of flu antigen that are best suited to patch-based delivery.

Needle-Free Anthrax Vaccine:
Iomai is currently working under a Department of Defense grant to perform preclinical work on a patch-based version of the anthrax vaccine. Under the 1-year grant, Iomai scientists are applying Iomai's technology in an effort to formulate a dry version of an anthrax antigen that can be combined with an Iomai adjuvant on a needle-free patch. Iomai will then evaluate the stability of the patch to determine whether it can be stored and shipped at room temperature.

IS Patch (Merck Vaccine):
Iomai has entered a research and development agreement with Merck & Co., Inc. to conduct proof-of-principle preclinical studies evaluating the use of Iomai’s needle-free immunostimulant patch with an undisclosed Merck vaccine. Merck has first option to negotiate an exclusive license.




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