IMDZ Immune Design Corp.

Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, today announced multiple presentations showcasing G100, its potent intratumoral TLR4 agonist, at the annual meeting for the Society for Immunotherapy of Cancer (SITC) being held in Washington D.C. this week. The presentations, which include both clinical and preclinical study data, further support the activity of G100 in follicular lymphoma patients and the potential combinability of G100 with other novel immune-modulatory agents.

“These additional positive clinical data continue to support the ability of G100 to trigger a systemic therapeutic effect when injected into a single tumor in follicular lymphoma patients,” said Carlos Paya, M.D., President and Chief Executive Officer of Immune Design. “In addition, we are pleased to observe that G100 can be synergistic with novel therapies such as anti-OX40 antibodies and adoptive T-cell therapies.”  

Key data to be presented:

• The higher dose (20ug) of intratumorally-administered G100 is active, as determined by clinical outcomes and increased biomarker activity in patients with follicular lymphoma  
  • Data from a new cohort of 18 follicular lymphoma patients treated with G100 at 20ug with low-dose radiation further confirms that G100 is active in the absence of an anti-PD-1 antibody and continues to have a favorable safety profile.  
  • Comparison of data from these 18 patients treated with G100 at 20ug versus data from 16 patients previously treated with 10ug shows:
    • Positive trend toward more rapid overall clinical responses, including in abscopal (untreated) lesions.
    • Increased TILs and decreased lymphoma-associated CD20 cells in tumors following G100 treatment, which are biomarkers previously associated with improved clinical responses.
    • Higher ORR (60%) is observed in patients stratified by baseline tumor high TLR4 expression.
    • Consistently favorable safety profile.
  • Based on these positive data, Immune Design has selected the 20ug dose of G100 for further clinical development. 
• Synergistic anti-tumor effects of G100 with anti-OX40 antibodies  
  • Combination of intratumoral G100 and systemic anti-OX40 monoclonal antibody is synergistic in aggressive lymphoma and melanoma preclinical models.
    • Improved anti-tumor activity in comparison to either agent alone.
    • Increased biomarker levels that correlate with effectiveness, such as TILs and the ratio of CD8/CD4 tumor-specific T cells. 
• G100 enhances the efficacy of adoptive T-cell therapy 
  • Combination of intratumoral injection of G100 and adoptive T-cell therapy was found to be synergistic in pre-clinical tumor models.
    • Tumor eradication observed in 70% of mice treated compared to no tumor regression with either approach alone.
    • Median survival was significantly improved with the combination regimen.

About G100

G100 is Immune Design’s lead product candidate and contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist called Glucopyranosyl Lipid A (GLA). G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor's preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor.  The induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. G100 is currently in development to treat patients with relapsed follicular lymphoma (FL), a sub-type of Non-Hodgkin lymphoma. Immune Design intends to start a study in earlier-stage lymphoma patients in combination with rituximab, a standard treatment for lymphomas, and is evaluating studies in other B-cell malignancies beyond FL, as well as potential solid tumor indications.

About Immune Design

Immune Design is a late-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 immune cells to fight cancer and other chronic diseases.  G100, the company’s lead product candidate, is a potent intratumoral TLR4 agonist that has shown clinical benefit in multiple tumor types. Building upon these data, including from a randomized Phase 2 study, Immune Design plans to further develop G100 with a potential first approval path in follicular lymphoma patients, a type of Non-Hodgkin lymphoma that affects thousands of patients annually. Immune Design’s technologies, the fundamental components of which were licensed from the California Institute of Technology and the Infectious Disease Research Institute (IDRI), also have potential application in infectious disease and allergy indications, which are being developed through ongoing pharmaceutical collaborations. Immune Design has offices in Seattle and South San Francisco. For more information, please visit www.immunedesign.com.

Cautionary Note on Forward-looking Statements

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,” “target,” “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 that could cause Immune Design’s clinical development programs, future results or performance to differ significantly from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, scope and results of clinical trials, the association of data with treatment outcomes, the timing and likelihood of obtaining regulatory approval of Immune Design’s product candidates, the estimated timing of cash remaining to fund operations and the projected value to stockholders. 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 enrolment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, 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.

Media ContactJulie Rathbunjulie.rathbun@immunedesign.com206-769-9219

Investor ContactSylvia Wheelersylvia.wheeler@immunedesign.com650-392-8318