Company Spotlight: Immune Design

(RTTNews) - Shares of Immune Design (IMDZ) are up an impressive 98% year-to-date, way ahead of the iShares NASDAQ Biotechnology Index's gain of 26% during the same period.

Immune Design is a clinical-stage immunotherapy company focused on oncology. The Company's discovery platforms, which go by the names ZVex and GLAAS, are designed to harness the immune system to fight cancer.

The Company has two clinical drug candidates, CMB305, an antigen specific, next-generation Cancer Vaccine, produced by the ZVex platform, and G100, an antigen agnostic, intratumoral immune activation, produced by the GLAAS platform.

CMB305 as a monotherapy is under a phase I study in patients with soft tissue sarcoma, and under a phase II study in combination with Genentech's cancer immunotherapy, Tecentriq.

The Company reported encouraging results from CMB305 monotherapy phase I study in June of this year. The observed median overall survival for sarcoma patients treated with CMB305 meaningfully exceeds standard of care benchmarks, says the Company.

Immune Design expects to receive FDA feedback related to pivotal path for CMB305 monotherapy by the fourth quarter of 2017.

Last month, Immune Design announced positive topline data from its interim analysis of the ongoing phase II trial evaluating CMB305 in combination with Roche's Tecentriq Vs Tecentriq alone in 88 soft tissue sarcoma patients.

According to the trial results, patients receiving CMB305 and Tecentriq experienced greater clinical benefit in the form of Disease Control Rate, Progression Free Survival and Time to Next Treatment than those receiving Tecentriq alone.

To be more specific, based on the interim analysis of 36 patients, the Disease Control Rate was 61% in the CMB305 plus Tecentriq arm compared to 28% in the Tecentriq alone arm. The Median Progression Free Survival was 2.6 months for the combination arm Vs 1.4 months for the Tecentriq alone arm. The Time to Next Treatment was 9 months for patients treated with CMB305 plus Tecentriq whereas it was 6.3 months for patients treated with Tecentriq alone.

Based on the full study population, the Disease Control Rate was 57% for the combination arm and 38% for Tecentriq alone arm.

The survival data from the phase II trial are expected to be presented in 2018 - when all patients have had at least one year of follow up.

Next in the pipeline is G100, which is being evaluated as a monotherapy in a Phase 1 study, and in a phase II trial in combination with Merck's Keytruda in patients with low-grade follicular non-Hodgkin lymphoma.

At ASCO 2016, the Company presented encouraging results from the phase I study based on data from nine patients with naïve and refractory follicular NHL. The study demonstrated 100% disease control rate, with over a third of patients achieving a partial response (PR) using WHO criteria (at least a 50% tumor reduction), with PRs at all three dose levels tested. In addition, 50% of evaluable patients experienced shrinkage of untreated distal (abscopal) lesions.

The phase II study of G100 in combination with Keytruda has completed patient enrollment. Data from this study are expected to be presented in December of this year.

Financials:

-- Cash as of June 30, 2017: $81.4 million -- Expected cash runway: Through the second half of 2018 -- Total shares outstanding: 25.6 million

IMDZ has traded in a range of $4.50 to $13.05 over the last 52 weeks. The stock is up 9.17% in pre-market trading on Friday.