Interim Results From Phase 1 Study Of Vaccine For Seasonal Influenza

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Iomai Corporation announced interim results from a Phase 1 clinical trial of its patch-based vaccine for seasonal influenza.

The company will hold a conference call at 8:30 a.m. Eastern Time today to discuss the results.

The 353-patient study compared the immune responses generated by Iomai's needle-free vaccine patch and an injected intramuscular vaccine. Both vaccines contained the same three flu antigens. The trial showed that Iomai's vaccine patch stimulated an immune response to each of the three antigens in a dose-dependent manner. However, results show that the injected vaccine prompted a greater immune response compared with the patch vaccine. The Iomai patch was well tolerated at all dose levels, consistent with previous safety data from other Iomai patch studies.

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"This Phase 1 trial has shown that we can deliver all three large flu antigens into the skin and to the immune system with our dry patch formulation," said Dr. Gregory Glenn, M.D., the Founder and Chief Scientific Officer of Iomai. "Both the Iomai patch and the injected vaccine used a type of antigen known as split-virus. While split-virus is the traditional approach for injected flu vaccines, such antigens may not be best suited for patch application. There are a number of alternatives being tested that we believe hold great promise."

The study also demonstrated that adding Iomai's immune-boosting adjuvant, known as LT, to the influenza antigens improved response to the patch vaccine. This finding will assist in the design of future trials in Iomai's needle-free influenza program.

"The efficient delivery of adjuvant seen in this trial is consistent with success in Iomai's other programs, including booster patches for seasonal and pandemic influenza," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "We believe this is a confirmation of our transcutaneous immunization, or TCI, technology, which makes patch-based, needle-free vaccine possible."

Iomai's needle-free approach to vaccination could have several potential benefits versus injectable vaccines. The patch formulations are stable at room temperature and the process of vaccination is designed so that a patch can be self-applied.

omai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, develop new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent E. coli-related travelers' diarrhea.

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