GAITHERSBURG, Md., April 3, 2008 IomaiCorporation (Nasdaq: IOMI) today announced that it has signed an agreementwith Merck & Co., Inc. to conduct proof-of-principle preclinical studiesevaluating the use of the Iomai needle-free immunostimulant patch.
Merck has first option to negotiate an exclusive license. Thesepreclinical proof-of-principle studies will be conducted using an undisclosedMerck vaccine. Iomai recently announced results of a 500-person Phase 1/2trial in which a clinically relevant adjuvant effect was observed when aversion of the immunostimulant patch was administered in combination with aninjected vaccine for pandemic influenza, and data from a prior European trialdemonstrated the ability of the immunostimulant patch to boost the immuneresponse of the elderly who receive an injected seasonal influenza vaccine.
"This agreement with Merck allows us to further evaluate the possibleapplications of our patch," said Stanley C. Erck, president and chiefexecutive officer of Iomai. "Our immunostimulant patch has the potential toimprove the immune response to a wide variety of vaccines, allowing for moreeffective vaccines, or vaccines that work at a lower dose."
The Iomai approach uses a potent adjuvant, applied to the skin through apatch that is affixed over the site of the injected vaccine. Once the patch isapplied, the adjuvant passes into the skin, targeting cells called Langerhanscells. Those specialized skin cells carry the adjuvant into the lymph nodes,where it works to boost an individual's immune response to the vaccine. Thisproprietary approach is known as transcutaneous immunization (TCI).
Last year, the Department of Health and Human Services (DHHS) awardedIomai a $128 million contract to fund the company's development of adose-sparing patch for use with a pandemic influenza vaccine, and thatcontract is currently funding the Phase 1/2 pandemic influenza trial. Thepatch being used in that program is similar to the one that will be used inthe Merck collaboration, with the same adjuvant and delivery system.
ABOUT IOMAI CORPORATION
Iomai Corporation discovers and develops vaccines and immune systemstimulants, delivered via a novel, needle-free technology calledtranscutaneous immunization (TCI). TCI, discovered by researchers at theWalter Reed Army Institute of Research, taps into the unique benefits of amajor group of antigen-presenting cells found in the outer layers of the skin(Langerhans cells) to generate an enhanced immune response. Iomai isleveraging TCI to enhance the efficacy of existing vaccines, develop newvaccines that are viable only through transcutaneous administration and expandthe global vaccine market. Iomai currently has four product candidates indevelopment: three targeting influenza and pandemic flu and one to preventtravelers' diarrhea. For more information on Iomai, please visithttp://www.iomai.com.
Some matters discussed in this press release constitute "forward-lookingstatements" that involve known and unknown risks and uncertainties that couldcause actual results to differ materially from those expressed or implied bythe forward-looking statements. Such forward-looking statements includestatements about the ability of the immunostimulant patch to improve theimmune response to vaccines, including by making them more effective or bylowering the effective dose, and the possibility of further collaboration withMerck beyond the initial preclinical studies described in this release.Applicable risks and uncertainties include, among others, that futurepreclinical and clinical trials may not replicate results seen in previousclinical trials; that pre-clinical studies described in this press release mayfail to indicate that the immunostimulant patch improves the immune responseor reduces the necessary vaccine dosage by as much as anticipated; that thetiming and effectiveness of the