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Immune Design Releases New PFS, OS and TME Data from Trials of Three Immuno-Oncology Product Candidates

SEATTLE and SOUTH SAN FRANCISCO, Calif., June 08, 2016 (GLOBE NEWSWIRE) -- Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, today announced updated results from clinical trials of three immuno-oncology product candidates demonstrating promising and potentially clinically meaningful anti-tumor immune responses for Immune Design’s lead products. This includes data presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) annual meeting and involves Immune Design’s two distinct immunotherapy applications – the ‘Specific Antigen’ and ‘Endogenous Antigen’ Approaches.

“The data reflect single agent Phase 1 studies and provide strong rationale for continued development, including our ongoing randomized Phase 2 studies,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer. “We believe both of our approaches are disruptive and have the potential to impact the immunotherapy treatment landscape.”

LV305 & CMB305: Specific Antigen Approach Targeting NY-ESO-1 Positive Tumors – Emerging Profile of Prolonged Survival Benefit

  • LV305 Phase 1 single agent trial completed in 24 patients with advanced or metastatic sarcoma cancers expressing NY-ESO-1 (ASCO abstract #3093)
    • Median overall survival (OS) has not been reached. One-year survival is 81%.
    • Median progression free survival (PFS) is 4.6 months.
    • 14 patients (58%) had clinical benefit: One patient (4%) had a late-onset partial response and 13 patients (54%) had stable disease.
      • 7/11 patients with pretreatment progressive disease (PD) had SD or PR following LV305.
    • Safety profile is very favorable, with only Grade 1/2 adverse effects (AEs).
  • CMB305 Phase 1 single agent trial ongoing in patients with NY-ESO-1 positive soft tissue sarcomas (preliminary analysis of first 14 patients)
    • Median OS has not been reached. 93% (13/14 patients) survival to date.
    • Median PFS is 5.5 months.
    • Best response to date is stable disease (10/14, 71%)
    • Safety profile is very favorable, with only Grade 1/2 AE

G100: Intratumoral Immune Activation Approach: Transforming “cold” tumors to “hot” tumors

  • G100 single agent and in combination with radiation in patients with Merkel cell carcinoma (ASCO Abstract #3021)
    • In final results from 10 patients, G100 produced a 50% overall response rate (ORR) per protocol, including a pathologic complete response (CR) following single agent G100 alone.
    • Four patients remain relapse-free in long-term follow up (range 13+ to 27.5+ months).
    • Analysis of the tumor microenvironment (TME) in G100-treated patients demonstrates the transformation of a “cold” to a “hot” tumor: increase of innate immune molecules that favor immune cell chemotaxis; increased NK cells and M1 macrophage markers; and dendritic cell antigen presentation. In addition, trafficking of CD4 and CD8 T cells from the stroma into the tumor bed was observed.
    • These changes in the TME were most prominent in the G100 responding patients.
    • No treatment-related AEs where observed; all AEs were grade 1/2.

Immune Design Company Update June 8

Immune Design will host a Company Update Event: “Progress, Platforms and Paths Forward” on Wednesday, June 8, at 5 p.m. Eastern. Presenters will include: David Baltimore, Ph.D., President Emeritus, California Institute of Technology; Nobel Laureate; Francine M. Foss, M.D., Professor of Medicine, Yale Cancer Center, and Robert G. Maki, M.D., Ph.D., Professor of Medicine, Pediatrics and Orthopaedics, Mt. Sinai Hospital; Director of Translational Research, Sarcoma Alliance for Research Through Collaboration.

A live webcast will be available online from the investor relations page of the company's corporate website at http://ir.immunedesign.com/events.cfm. After the live webcast, an archive of the presentation will be available on the company website for 30 days.

Investors and analysts who would like to attend the Immune Design event in New York should contact Jennifer Cortes at jennifer.cortes@immunedesign.com.

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 two-pronged focus of Immune Design's ongoing immuno-oncology clinical programs, are the product of its two synergistic discovery platforms, ZVexTM and GLAASTM. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.

Media Contact Julie Rathbun Rathbun Communications julie@rathbuncomm.com 206-769-9219 Investor Contact Shari Annes Annes Associates shari.annes@immunedesign.com 650-888-0902

Source:Immune Design Corp