On May 10, 2016 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate review for the first quarter ended March 31, 2016 (Press release, Immune Design, MAY 10, 2016, View Source [SID:1234512268]).

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"During the first quarter, we progressed both clinical product development and discovery research activities," said Carlos Paya, M.D., Ph.D., president and chief executive officer of Immune Design. "We continued to enroll patients in randomized Phase 2 studies evaluating both of our lead immuno-oncology product candidates, CMB305 and G100, and we are initiating activities in the emerging field of neoantigen-based personalized therapies."

Recent Highlights

Product Development Progress

Specific Antigen Approach: Targeting NY-ESO-1 positive Soft Tissue Sarcomas

LV305 Phase 1 single agent trial

Enrollment is complete with sufficient follow-up of a large cohort of patients indicating a favorable safety profile and a positive signal in clinical endpoints such as progression-free survival (PFS) and survival.

The complete data will be presented at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

CMB305 Phase 1 single agent trial

Enrollment in the expansion arm is in progress.

Thus far the safety profile is favorable, and a positive signal in PFS- related endpoints was observed.

The Company plans to provide data at the Immune Design Company Update event in New York City on Wednesday, June 8.

Immune Design recently received Orphan Designation from the FDA for this product.

CMB305 randomized Phase 2 trial

Enrollment is ongoing in the 80-patient trial evaluating CMB305 with atezolizumab, Genentech’s anti-PD-L1 checkpoint inhibitor, versus atezolizumab alone.

A first analysis is planned for the fourth quarter of this year.
Intratumoral Immune Activation Approach: Evaluation in Merkel cell carcinoma (MCC), Sarcoma and follicular non-Hodgkin Lymphoma (fNHL)

G100 single agent and in combination with radiation Phase 1 trial in MCC patients

Enrollment has completed, with a consistent safety and clinical benefit profile.

A thorough analysis of the tumor micro-environment before and after G100 injection demonstrates increased tumor inflammation ("hot" tumor).

Full data set will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting.

G100 single agent and in combination with radiation Phase 1 trial in sarcoma patients

Investigator-sponsored trial at the Fred Hutchinson Cancer Research Center is ongoing in sarcoma patients with accessible lesions.

Evaluating dose response of G100 for safety, clinical signal and tumor micro-environment changes of a traditionally "cold" tumor.

Initial data will be presented at the upcoming ASCO (Free ASCO Whitepaper) meeting.

G100 and low dose radiation in combination or not with Keytruda Phase 1/2 trial in fNHL

Enrollment is ongoing in part 1: G100 dose-escalation.

We expect enrollment for part 1 and part 2 (randomized with Keytruda) to be completed by year-end.
New Clinical Collaboration targeting Neoantigens with Gritstone Oncology

A collaboration announced on May 9, 2016 will involve the application of Immune Design’s ZVexTM discovery platform with Gritstone’s proprietary genomics and proteomics platform for identification of patient-specific tumor antigens to develop neoantigen-based immunotherapies.
Research Activities Progress

Immune Design is evaluating the ZVex IL-12 vector as a potential addition to its intratumoral activation approach.

Preclinical results were presented at the recent American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
Financial Results

First Quarter

Immune Design ended the first quarter of 2016 with $100.8 million in cash and investments, compared to $112.9 million as of December 31, 2015. Net cash used in operations for the three months ended March 31, 2016 was $12.1 million.

Net loss and net loss per share for the first quarter of 2016 were $12.3 million and $0.61, respectively, compared to $9.4 million and $0.56, respectively, for the first quarter of 2015.

Revenue for the first quarter of 2016 was $1.9 million and was attributable primarily to the Sanofi G103 (HSV2 therapeutic vaccine) collaboration established in the fourth quarter of 2014. Revenue for the first quarter of 2015 was similar, $1.9 million, and was attributable primarily to $1.8 million in collaboration revenue associated with Sanofi G103 collaboration and $0.1 million in product sales.

Research and development expenses for the first quarter of 2016 were $10.6 million, compared to $7.5 million for the first quarter of 2015. The $3.1 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 first quarter of 2016 general and administrative expenses were $3.9 million, compared to $3.8 million for the first quarter of 2015.