On August 9, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the second quarter ended June 30, 2016 (Press release, Immune Design, AUG 9, 2016, View Source [SID:1234514421]).
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"The positive data we presented during the second quarter provide a strong rationale for the continued advancement of our two lead programs, CMB305 and G100," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "These two programs offer distinct approaches that use the patient’s immune system to fight cancer, and which are different from previous efforts in this field."
Recent Highlights
Product Development Progress
Specific Antigen Approach: LV305/CMB305 and ZVex-Neo Programs
LV305/CMB305: Positive data in NY-ESO-1 Soft Tissue Sarcoma (STS) patients, Phase 2 combination study in collaboration with Genentech ongoing.
LV305: Positive PFS and OS data in STS
Data from the single agent Phase 1 study in 24 patients with advanced or metastatic soft tissue sarcoma, which were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, revealed:
clinical benefit for 58% of the patients in the form of partial response (PR) or stable disease (SD);
median progression-free survival (PFS) of 4.6 months and a median overall survival (OS) that had not yet been reached, with 81% of the patients alive at one year; and
very favorable safety profile, with no Grade 3/4 adverse events (AEs)
We believe these data compare favorably with approved STS agents and further support the applicability of the mechanism of action of the Prime/Boost agent, CMB305, in STS, and as a potential first registration path for an Immune Design product.
CMB305: (1) positive STS signal in early look; and (2) randomized Phase 2 combination study with Genentech’s anti-PDL1 antibody, TECENTRIQ (atezolizumab) ongoing in STS
Early data from the single agent Phase 1 study in 14 patients with STS showed
the median OS had not been reached, with 93% of the patients alive at one year, and the median PFS was 5.5 months, both of which we believe compare favorably to approved chemotherapy agents for STS patients who have received at least one or more prior therapies;
a favorable safety profile, with only Grade 1/2 AEs; and
a deeper immune response than seen in the LV305 Phase 1 study, including a trend of increased T cell clonality.
A randomized 80-patient Phase 2 study of CMB305 with or without the anti-PD-L1 checkpoint inhibitor, atezolizumab, is ongoing in patients with STS
Part 1 of the study included a safety run in, which was deemed favorable by an independent Data Monitoring Committee, allowing enrollment in part 2 of the study to commence.
ZVex-Neo: Neoantigen Collaboration with Gritstone Oncology
In May 2016, Immune Design announced a collaboration with Gritstone Oncology to combine Immune Design’s ZVex discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies. The collaboration has commenced, with the intent to begin a study in patients with non-small cell lung cancer in 2017 in combination with a checkpoint inhibitor of the PD-1/PD-L1 axis.
Intratumoral Immune Activation Approach: Positive Clinical and Translational Data
G100: (1) positive final Phase 1 results in Merkel cell carcinoma (MCC); and (2) randomized Phase 2 combination with KEYTRUDA (pembrolizumab) in follicular non-Hodgkin’s lymphoma (NHL) in collaboration with Merck is ongoing
The final results of a 10-patient Phase 1 study of G100 administered intratumorally and combined with radiation in patients with MCC, which were presented at the ASCO (Free ASCO Whitepaper) annual meeting, revealed:
a 50% overall response rate (ORR) per protocol, including one of the complete responses (CR) resulting from single agent G100 alone (no radiation);
no treatment-related AEs were observed, and all AEs were grade 1/2; and
analysis of the tumor microenvironment (TME) in G100-responding patients demonstrated the increase of innate immune molecules that favor (i) immune cell chemotaxis, (ii) increased NK cells and M1 macrophage markers, and (iii) dendritic cell antigen presentation and dynamics of adaptive immunity such as trafficking of CD8 and CD4 T cells from the stroma into the tumor bed, underscoring the transition to a "hot" tumor.
A randomized Phase 2 study of G100 with low dose radiation, with Merck’s checkpoint inhibitor KEYTRUDA (pembrolizumab) in NHL patients is ongoing.
Part 1 (dose escalation of G100 without Keytruda) was deemed safe, allowing the move to Part 2 of the study, in which patients are randomized to receive Keytruda in combination with G100 and radiation or G100 and radiation alone.
Expansion of the Team
Susan L. Kelley M.D. Joins Board of Directors: Addition of Oncology Development Expertise
Dr. Susan L. Kelley joined the Immune Design Board in June 2016, and brings more than 25 years’ experience in oncology and immunology drug development to the company.
Financial Results
Second Quarter
Immune Design ended the second quarter of 2016 with $92.6 million in cash, cash equivalents and short-term investments, compared to $112.9 million as of December 31, 2015. Net cash used in operations for the six months ended June 30, 2016 was $20.4 million.
Net loss and net loss per share for the second quarter of 2016 were $14.3 million and $0.71, respectively, compared to $10.5 million and $0.54, respectively, for the second quarter of 2015.
Revenue for the second quarter of 2016 was $1.1 million and was attributable primarily to the Sanofi G103 (HSV2 therapeutic vaccine) collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners Medimmune/Astra Zeneca and Sanofi. Revenue for the second quarter of 2015 was $1.8 million and was attributable primarily to collaboration revenue associated with Sanofi G103 collaboration.
Research and development expenses for the second quarter of 2016 were $11.4 million, compared to $8.5 million for the second quarter of 2015. The $2.9 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials.
General and administrative expenses did not materially differ over the comparative periods. For the second quarter of 2016 general and administrative expenses were $3.9 million, compared to $3.8 million for the second quarter of 2015.
Year-to-Date
Net loss and net loss per share for the six months ended June 30, 2016 were $26.6 million and $1.32, respectively, compared to $19.9 million and $1.10, respectively, for the same period in 2015.
Revenue for the six months ended June 30, 2016 was $3.0 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration established in the fourth quarter of 2014 and GLA product sales to collaboration partners. Revenue for the same period in 2015 was $3.7 million and was attributable primarily to collaboration revenue associated with the Sanofi G103 collaboration.
Research and development expenses for the six months ended June 30, 2016 were $22.0 million compared to $15.9 million for the same period in 2015. The $6.0 million increase was primarily attributable to continuing advancement of Immune Design’s ongoing research and development programs, including ongoing Phase 1 and Phase 2 clinical trials and an increase in personnel-related expenses to support the company’s advancing research and clinical pipeline.
General and administrative expenses did not materially differ over the comparative periods. For the six months ended June 30, 2016 general and administrative expenses were $7.9 million, compared to $7.6 million for the same period in 2015.