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Oct 29, 2015

MEDI7510 for Respiratory Syncytial Virus Advances to Phase 2 Leverages Immune Design's GLAAS(TM) Discovery Platform

SEATTLE and SOUTH SAN FRANCISCO, Calif., Oct. 29, 2015 (GLOBE NEWSWIRE) -- Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today highlighted the application of its GLAASTM discovery platform in MedImmune's Phase 2 clinical trial of MEDI7510. MEDI7510 is an investigational agent for the prevention of respiratory syncytial virus (RSV) under development by MedImmune, the global biologics research and development arm of AstraZeneca. MEDI7510 is composed of MedImmune's RSV sF antigen plus GLA, a synthetic molecule licensed from Immune Design's GLAAS discovery platform.

This stems from an existing agreement in which Immune Design granted MedImmune an exclusive license to use the GLAAS platform to develop and commercialize vaccines in two different infectious disease indications, one of which is RSV.

The Phase 2, double-blind, randomized, placebo-controlled study (NCT02508194) is designed to assess the efficacy of MEDI7510 for the prevention of acute RSV-associated respiratory illness in older adults. The study will also evaluate the safety and immunogenicity of MEDI7510 or placebo and immune response to MEDI7510 in Season 1 and Season 2. The trial is expected to enroll approximately 1,900 adult subjects, 60 years or older, globally.

"It's rewarding to see MEDI7510 continue to advance through clinical development," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer at Immune Design. "The field of RSV vaccines has been challenging. A small molecule that activates TLR4 and drives a Th1-type of immune response should be ideally suited to overcome the Th2-prone activity of RSV antigens, which can result in severe lung pathology. We are hopeful of the potential benefit MEDI7510 may bring to older adults."


Respiratory Syncytial Virus (RSV) is a common virus that can cause upper and lower respiratory infections, including colds, bronchitis and pneumonia. RSV is increasingly recognized as an important cause of respiratory infections in adults, particularly affecting the elderly, immunocompromised, and those with underlying chronic cardiopulmonary disease. For example, RSV is estimated to infect 5%-10% of nursing home residents per year, with rates of pneumonia and death of 10%-20% and 2%-5%, respectively (Falsy, Clin Microbiol Rev 2000). Currently no vaccine is available for RSV and induction of a Th1 type immune response is viewed as an important feature for any successful vaccine candidate.


Immune Design's GLAAS platform works in vivo and is based on a small synthetic molecule called GLA, which stands for glucopyranosyl lipid A. GLA selectively binds to the TLR4 receptor and causes potent activation of dendritic cells (DCs). When GLA is accompanied by an antigen and injected into a patient, the combination is taken up by DCs and leads to the production and expansion of immune cells called CD4 T helper lymphocytes. These CD4 cells play a key role in boosting the anti-tumor immune response by expanding the number and function of existing CTLs that are specific to the same antigen and providing help to other immune cells, including B lymphocytes that are the precursor to antibodies and natural killer cells that are also important in the overall immune response. In addition to infectious diseases, Immune Design believes that GLAAS product candidates have the potential to target multiple types of cancer and allergic diseases.

About Immune Design

Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's technologies are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic T cells, while also enhancing other immune effectors, to fight cancer and other chronic diseases. CMB305 and G100, the primary focus of Immune Design's ongoing immuno-oncology clinical programs, are products of its two synergistic discovery platforms, ZVexTM and GLAASTM, the fundamental technologies of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), respectively.  Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.

Forward Looking Statement:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Immune Design's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the timing of initiation, progress, scope and outcome of clinical trials for Immune Design's product candidates and the reporting of clinical data regarding Immune Design's product candidates. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Immune Design's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Immune Design's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Immune Design's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Immune Design assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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