On June 08, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported 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 (Press release, Immune Design, JUN 8, 2016, View Source [SID:1234513139]). This includes data presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and involves Immune Design’s two distinct immunotherapy applications — the ‘Specific Antigen’ and ‘Endogenous Antigen’ Approaches.

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"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.