On November 1, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the third quarter ended September 30, 2017 (Press release, Immune Design, NOV 1, 2017, View Source [SID1234521433]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

“During the third quarter, we made significant progress on our strategy to bring a novel cancer vaccine to market. Our discussions with the FDA resulted in positive feedback on a Phase 3 trial design and approval criteria for CMB305 as a monotherapy for synovial sarcoma patients in the maintenance setting — a significant milestone for the company,” said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. “In addition, at ESMO (Free ESMO Whitepaper) we presented interim analysis data from our ongoing randomized Phase 2 study of CMB305 and atezolizumab showing that patients receiving the combination therapy experienced greater clinical benefit and immune response than those receiving atezolizumab alone.”

Recent Highlights

CMB305 Monotherapy: progressing to pivotal Phase 3 in synovial sarcoma patients
Based on productive discussions with the FDA, Immune Design announced plans to initiate a pivotal Phase 3 randomized trial to support a Biologics License Application for CMB305 in patients with synovial sarcoma.
The trial will compare CMB305 vs. placebo in NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma patients without evidence of progression after first-line chemotherapy (“maintenance setting”).
Immune Design intends to start the study in mid-2018 and enroll 248 patients aged 12 and older.
Progression free survival (PFS) and overall survival will be co-primary endpoints.
PFS analysis may occur as early as 24 months from the first patient dosed, depending on the number of events.
CMB305 Combination Therapy (CMB305+Atezolizumab vs Atezolizumab) Randomized Phase 2 Trial: interim analysis presented at ESMO (Free ESMO Whitepaper) 2017 shows greater benefit in sarcoma patients receiving the combination
The interim analysis (n=36 patients) data showed that NY-ESO-1+ synovial sarcoma or mixoid round cell liposarcoma patients receiving the combination of CMB305 and Genentech’s checkpoint inhibitor, Tecentriq (atezolizumab) experienced greater clinical benefit, in the form of Disease Control Rate (including partial responses), median Progression Free Survival and Time to Next Treatment, as well as immune response, than those receiving atezolizumab alone.
In the full study population (n=88), the trend of greater clinical benefit on the combination arm remains consistent.
G100 +/- pembrolizumab data in follicular NHL patients to be presented at ASH (Free ASH Whitepaper); receipt of EMA Orphan Drug designation
The American Society of Hematology (ASH) (Free ASH Whitepaper) has accepted an Immune Design presentation for its Annual Meeting in December 2017.
Data from a randomized, 26-patient, Phase 2 study evaluating G100, the novel, synthetic TLR4 agonist injected intratumorally, and low-dose radiation (XRT), versus G100 and XRT with the systemic administration of Merck’s anti-PD-1 antibody, Keytruda (pembrolizumab) will be presented.
The data in the submitted abstract show:
a 31% ORR for patients receiving G100+XRT+pembrolizumab (G+P), as compared to a 15% ORR for patients receiving G100+XRT (G); and
shrinkage of untreated (abscopal) tumors in 62% of patients receiving G+P and 46% of patients receiving G.
These abstract data are earlier (June 2017) than the data that will be presented in the planned presentation. The updated data appear to demonstrate a stronger clinical response and biomarker profile for those patients receiving G100, XRT and pembrolizumab, as compared to those patients receiving G100 and XRT alone.
G100 received Orphan Drug Designation for the treatment of follicular non-Hodgkin’s lymphoma from the EMA in October 2017.
Additional Upcoming Presentations

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) has accepted five Immune Design abstracts for presentation at its 32nd Annual Meeting, November 8-12, 2017 in National Harbor, Maryland. The oral and poster presentations are as follows:

Novel Biomarkers in Next-generation Cancer Vaccines: Public NY-ESO-1 specific TCRs as novel biomarkers for immune monitoring of NY-ESO-1 positive cancer patients
Combination Therapy (Cancer Vaccine + Intratumoral Immunization): G100 and ZVex-based combination immunotherapy induces near complete regression of established glioma tumors in mice
Multi-Target Cancer Vaccines: Transduction of MAGE-A1, A3, A4, A10 and IL-12 by ZVex, a dendritic cell targeting platform induces robust multi-antigen T-cell immune responses without antigenic interference or immunodominance
Next-Generation Intratumoral Vaccination Using ZVex: Intratumoral expression of IL12 using the ZVex dendritic cell-targeting lentiviral vector exerts potent anti-tumor effects via induction of multiple immune effectors, including CD8 T cell responses
Anti-NY-ESO-1 Immune Response and Survival Benefit After LV305 Therapy in Patients With Advanced Sarcoma and Other Solid Tumors
In addition to an investigator-sponsored presentation, at the Connective Tissue Oncology Society (CTOS) Annual Meeting being held in Maui from November 8-11, Immune Design will be presenting data from the ASCO (Free ASCO Whitepaper) annual meeting in two presentations:

A Phase 2 Study of CMB305 and Atezolizumab in NY-ESO-1+ Soft Tissue Sarcoma: Interim Analysis of Immunogenicity, tumor control and survival.
Association of NY-ESO-1 Expression with Baseline Immunity and Clinical Outcomes in Soft Tissue Sarcoma Patients Treated with LV305 or CMB305.
Completion of Follow-On Financing

On October 27, 2017, Immune Design completed an underwritten follow-on public offering, which resulted in the sale of 22,425,000 shares of common stock, inclusive of the full exercise by the underwriters of the 30-day option to purchase 2,925,000 additional shares, at a public offering price of $4.10 per share. Estimated net proceeds from the offering were $86.6 million after deducting underwriting discounts and commissions and estimated offering expenses of $5.4 million. Both new and existing investors participated in the offering.

Financial Results

Third Quarter

Immune Design ended the third quarter of 2017 with $67.5 million in cash, cash equivalents, short-term investments and other receivables, compared to $110.4 million as of December 31, 2016. Net cash used in operations for the nine months ended September 30, 2017 was $43.2 million.

Net loss and net loss per share for the third quarter of 2017 were $13.4 million and $0.52, respectively, compared to $12.4 million and $0.60, respectively, for the third quarter of 2016.

Revenue for the third quarter of 2017 was $0.5 million and was primarily attributable to collaboration revenue associated with the Sanofi G103 HSV therapeutic vaccine product collaboration. Revenue for the third quarter of 2016 was $8.2 million and was primarily attributable to $7.0 million in license revenue, $0.4 million in product sales associated with Immune Design’s collaboration partner Sanofi and $0.8 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the third quarter of 2017 were $10.2 million compared to $11.2 million for the same period in 2016. The $1.0 million decrease was primarily attributable to a decrease in in-licensing royalties and fees to other third parties that the company licenses various technologies from and a decrease in contract manufacturing activities primarily driven by the timing of when services are performed. These decreases were offset by an increase in personnel-related expenses and facility costs to support the company’s advancing research and clinical pipeline.

General and administrative expenses for the third quarter of 2017 were $3.9 million compared to $9.6 million for the same period in 2016. The $5.7 million decrease was primarily attributable to the settlement and license agreements with TheraVectys SA (TVS) involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Year-to-Date

Net loss and net loss per share for the nine months ended September 30, 2017 were $39.9 million and $1.56, respectively, compared to $39.1 million and $1.92, respectively, for the same period in 2016.

Revenue for the nine months ended September 30, 2017 was $6.7 million and was primarily attributable to $6.4 million in collaboration revenue associated with the Sanofi G103 product collaboration and $0.3 million in product sales to other third parties. Revenue for the same period in 2016 was $11.2 million and was primarily attributable to $7.0 million in license revenue, $1.2 million in product sales associated with Immune Design’s collaboration partner Sanofi and $3.0 million in collaboration revenue associated with the Sanofi G103 product collaboration.

Research and development expenses for the nine months ended September 30, 2017 were $35.1 million compared to $33.1 million for the same period in 2016. The $2.0 million increase was primarily attributable to continued 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 for the nine months ended September 30, 2017 were $11.9 million compared to $17.4 million for the same period in 2016. The $5.5 million decrease was primarily attributable to the settlement and license agreements with TVS involving the acquisition of certain present and future intellectual property rights from TVS and resolving the litigation initiated by TVS in July 2014 against the company, as well as related claims and counterclaims.
Cash Guidance

Based on current expectations following Immune Design’s recent follow-on offering, the company expects to have cash to fund operations into 2020.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 1:30 p.m. Pacific time / 4:30 p.m. Eastern time to discuss the third quarter 2017 financial results and provide a corporate update.

The live call may be accessed by dialing 844-266-9538 for domestic callers and 216-562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the company website at View Source A telephone replay of the call will be available for five days by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code:4793869

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.