GAITHERSBURG, Md., May 3 /PRNewswire-FirstCall/ -- Iomai Corporation today announced it has submitted to the Department of Health and Human Services (DHHS) a proposal to receive government funding for further development of its adjuvant skin patch for pandemic influenza. Iomai’s skin patch is designed to boost the effectiveness of any manufactured influenza vaccine, allowing the public health service to employ a recommended dose- sparing strategy that utilizes smaller doses of the actual vaccine to extend the supply. In line with the government’s request for proposal (RFP), Iomai will develop a plan to produce 150 million doses of its dose-sparing patch in a six-month period if awarded the contract.
Iomai’s proposal comes in response to an RFP issued March 17 by DHHS. That request said DHHS is looking to “stretch the domestic influenza vaccine supply in the event of an influenza pandemic,” by awarding multi-year contracts for the preclinical study, clinical testing and regulatory development targeted to selected groups developing dose-sparing approaches.
“We believe Iomai’s technology is uniquely responsive to the government’s RFP,” said Stanley C. Erck, President and Chief Executive Officer of Iomai. “Our technology uses a novel adjuvant and route of delivery and is designed to boost the immune response to a given dose of vaccine, potentially allowing much smaller doses of vaccine to be administered, a ‘dose-sparing’ approach to vaccination.”
The Iomai patch is designed to be used in conjunction with any manufactured influenza vaccine. After a dose of injected vaccine, the Iomai patch, similar in appearance to a small adhesive bandage, is placed over the vaccination site. There, the adjuvant passes through the skin via specialized cells called Langerhans cells and into the lymph nodes where it works to boost a person’s immune response to the vaccine. This proprietary approach, known as transcutaneous immunization (TCI), has been shown in a clinical study to boost immune responses to traditional influenza vaccines.
Iomai’s plan, in accordance with the requirements laid out in the RFP, will accelerate development of its patch. If awarded the DHHS grant, Iomai is prepared to scale up production of the patches, validate its production process, and design and build a facility capable of large-scale production. The Iomai proposal calls for the company to be prepared to make commercial product by the end of 2009.
DHHS said it expects to make the awards on or about September 30, 2006.
The original RFP is available here: http://fs1.fbo.gov/EPSData/HHS/Synopses/37271/ORDC-VB-05-08/RFP05-0803- 17finaldraft.pdf
ABOUT IOMAI CORPORATION
Iomai 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. For more information on Iomai, please visit www.iomai.com.
Forward Looking Statement
Some matters discussed in this press release constitute “forward-looking statements” that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements about the ability of Iomai’s patches to stimulate stronger immune responses and to function as a dose-sparing approach to vaccination, that DHHS may select Iomai’s approach for further funding and development, and the likelihood of Iomai’s proposal to be responsive to the DHHS RFP. Applicable risks and uncertainties include, among others, that results in future Phase 2 and Phase 3 trials may not replicate results seen in the trials described in this press release; that Iomai may not be able to enroll sufficient numbers of patients in future clinical trials; that Iomai may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials; that Iomai may encounter substantial difficulties in attempting to scale-up its manufacturing capacity; that development costs may exceed expectations; that Iomai may fail to adequately protect its intellectual property or may be determined to infringe on the intellectual property of others; and the risks identified under the heading “Risk Factors: in the Company’s Annual Report on Form 10-K for the year ended December 31, 2005 and filed with the Securities and Exchange Commission. Iomai cautions investors and others not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company’s filings for a discussion of these and other risks and uncertainties which are filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
These statements speak only as of the date of this document, and Iomai undertakes no obligation to update or revise the statements.
Iomai Corporation
CONTACT: Russell P. Wilson, Senior Vice President, Chief Financial Officerand General Counsel of Iomai Corporation, +1-301-556-4478, orinvestors@iomai.com; or Jennifer Larson of WeissComm Partners,+1-415-409-2729, or jlarson@weisscommpartners.com, for Iomai
Web site: http://www.iomai.com//
