On May 17, 2017 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology, reported financial results and a corporate update for the first quarter ended March 31, 2017 (Press release, Immune Design, MAY 17, 2017, View Source [SID1234519205]). Schedule your 30 min Free 1stOncology Demo! "During the first quarter of the year, we were pleased to complete enrollment in the first randomized studies for each of CMB305 and G100, an important milestone for Immune Design," said Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design. "We hope that the emerging biomarker and clinical data that we intend to present starting at ASCO (Free ASCO Whitepaper) and continuing throughout 2017, may form the initial foundation to support commercialization of novel and safe immunotherapies for selected cancer patients."
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Recent Highlights
Product Development: Two Phase 2 randomized studies fully enrolled; multiple ASCO (Free ASCO Whitepaper) presentations; Orphan Drug status for G100 in follicular NHL
Antigen Specific Immunotherapy: CMB305 Program
CMB305, the novel, prime-boost NY-ESO-1 targeted immunotherapy, is being evaluated primarily in soft tissue sarcoma (STS) patients both as a monotherapy and in combination with an anti-PD-L1 antibody.
CMB305 monotherapy
Follow-up continues on the two enrolled monotherapy Phase 1 trials (25 CMB305 STS patients, and 23 STS patients treated with CMB305’s vector-only component, LV305).
Data from the CMB305 trial will be presented in two separate presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in 2017 (ASCO 2017):
Both clinical and translational data from at least 25 STS patients will be presented in an oral presentation entitled "Immune response, safety, and survival impact from CMB305 in NY-ESO-1+ recurrent soft tissue sarcomas (STS)"; and
An analysis of translational data indicating an association of baseline and immunotherapy (LV305 and CMB305)-induced NY-ESO-1 immune response with survival in patients with multiple tumor types, will be presented in a poster presentation entitled "Association of CMB305 or LV305-induced and baseline anti-NY-ESO-1 immunity with survival in recurrent cancer patients."
CMB305 combination therapy with Tecentriq
Enrollment was completed by the end of Q1 in the randomized, 80-patient, Phase 2 study comparing CMB305 plus Tecentriq (atezolizumab) vs. atezolizumab alone, pursuant to a collaboration with Genentech.
Immune Design intends to submit early data from a pre-specified analysis of this Phase 2 study for presentation at the European Society for Medical Oncology 2017 Congress to be held in September 2017.
Antigen Agnostic Intratumoral Immunotherapy: G100 Program
G100, the novel, synthetic TLR4 agonist injected intratumorally, is being evaluated in an ongoing Phase 1 dose escalation and in a randomized Phase 2 trial in patients with low grade follicular non-Hodgkin lymphoma (FL).
G100 monotherapy (with low dose radiation (XRT)). Data from the fully enrolled Phase 1 dose escalation monotherapy portion of the trial (n=9) evaluating G100 with XRT will be presented at ASCO (Free ASCO Whitepaper) 2017 in a poster presentation entitled "Intratumoral G100 induces systemic immune responses and abscopal tumor regression in patients with follicular lymphoma."
G100 and XRT combination therapy with Keytruda:
Patient enrollment was completed by the end of Q1 in the randomized, 24-patient, Phase 2 study comparing G100 and XRT versus G100 and XRT with the systemic administration of the anti-PD-1 antibody, Keytruda (pembrolizumab), pursuant to a collaboration with Merck.
Immune Design intends to submit follow-up data from all patients in both the Phase 1 dose escalation and Phase 2 randomized portions of the study for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2017.
The U.S. Food and Drug Administration recently granted Orphan Drug Designation for G100 for the treatment of FL. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
Financial Results
First Quarter
Immune Design ended the first quarter of 2017 with $90.1 million in cash and 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 three months ended March 31, 2017 was $17.4 million.
Net loss and net loss per share for the first quarter of 2017 were $12.6 million and $0.50, respectively, compared to $12.3 million and $0.61, respectively, for the first quarter of 2016.
Revenue for the first quarter of 2017 was $5.5 million and was primarily attributable to $5.2 million in collaboration revenue associated with the Sanofi G103 (HSV2 therapeutic vaccine) collaboration and $0.3 million in product sales to other third parties. Revenue for the first quarter of 2016 was $1.9 million and was primarily attributable to the Sanofi G103 collaboration.
Research and development expenses for the first quarter of 2017 were $14.0 million compared to $10.6 million for the same period in 2016. The $3.4 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 first quarter of 2017 were $4.1 million, relatively consistent with general and administrative expenses of $3.9 million recorded in the first quarter of 2016.
Cash Guidance
Based on current expectations, Immune Design continues to expect to have cash to fund operations into the second half of 2018.