Epimmune's HIV Vaccine Candidate Taken by the National Institutes of Health and HIV Vaccine Trials Network Into Phase I Preventative Vaccine Trial in the U.S. and Africa

SAN DIEGO -- Epimmune Inc. announces that the National Institute of Allergy and Infectious Diseases, a component of the National Institutes of Health (NIH), holds an active Investigational New Drug (IND) from the FDA to test Epimmune's multi-epitope vaccine, EP HIV-1090, to prevent HIV infection. A multi-site, Phase I trial was recently initiated by the HIV Vaccine Trials Network (HVTN), which is conducting the trial. Trial sites include several New England and one African (Botswana) site associated with Harvard University, and one site associated with Saint Louis University. The total planned trial enrollment is 42 subjects, and the primary endpoint of the trial will be to determine the safety of the vaccine.

Mark Newman, PhD, vice president of infectious diseases at Epimmune said, "We are very pleased to see our EP HIV-1090 vaccine, which Epimmune is evaluating under our own IND in a therapeutic setting in HIV-1-infected patients, also being evaluated in a prophylactic setting by the NIH. Because the HVTN has extensive experience in prophylactic vaccine trials, it represents an ideal setting to evaluate our HIV vaccine candidate."

"The HVTN welcomes the opportunity to collaborate on this trial with Epimmune," said Dr. Larry Corey, principal investigator for HVTN. "The testing of multiple vaccine candidates is critical to speeding progress toward an HIV vaccine and controlling the global pandemic, and we are pleased to offer our clinical trial network to vaccine inventors."

The EP HIV-1090 vaccine candidate is composed of DNA that has been synthetically produced through genetic engineering and contains no natural HIV elements. The DNA includes 21 key elements (epitopes) modeled from conserved regions of multiple HIV virus proteins. These epitopes were selected for their ability to induce immune responses (cytotoxic T-cells) able to kill HIV- infected cells. This selection used Epimmune proprietary processes. In addition, the vaccine candidate includes Epimmune's PADRE(R) universal helper T-cell epitope that is designed to enhance the magnitude and duration of responses.

Epimmune Inc., based in San Diego, is focused on the development of pharmaceutical products using multiple epitopes to specifically activate the body's immune system. Epitopes, critical signaling molecules, stimulate the T-cell arm of the immune system to respond to specific regions of cancer cells or infectious agents. By combining multiple, selected epitopes into a single drug candidate, the immune response can be both targeted and optimized for strength. Epimmune's therapeutic drug candidates have been designed to treat disease by stimulating the body's immune system to respond aggressively to infections, such as HIV, hepatitis C virus and hepatitis B virus, and tumors such as breast, colon, lung and prostate. The company's preventative drug candidates have been designed to protect against disease by teaching the body's immune system to react quickly when exposed to infectious agents. Epimmune's technology can also be used to identify and potentially eliminate undesirable reactions to therapeutic drugs or consumer products by modifying specific epitopes to suppress the unwanted immune response. In addition, Epimmune previously announced that it has preliminarily agreed to merge its operations with Anosys, Inc. to create a combined company focused on the field of immunotherapeutics and products for the treatment of cancer and infectious diseases. The all-stock transaction is subject to the parties entering into a definitive merger agreement, approval by the shareholders of both companies, obtaining commitments for capital resources to fund the combined company's operations and various other conditions that must be satisfied prior to closing the merger

Source: Epimmune Inc.

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