Immune Design Poised On Progress Of Pipeline Candidates
Zacks Investment Research | Mar 18, 2018 10:30PM ET
We issued an updated report on Immune Design Corp. (NASDAQ:IMDZ) on Mar 16.
The company is currently developing several candidates in the field of immuno-oncology based on its ZVex and GLAAS platforms. The company’s key pipeline candidates are CMB305 and G100. CMB305 is being evaluated in soft tissue sarcoma patients both as a monotherapy (phase I) and in combination with Roche’s (OTC:RHHBY) anti-PDL1 cancer immunotherapy —Tecentriq (phase II).
The company had a favorable meeting with the FDA regarding CMB305 and has planned to initiate a pivotal phase III trial evaluating CMB305 as a monotherapy in synovial sarcoma patients by mid 2018. The patients will be randomized 1:1, with co-primary endpoints of progression free survival (PFS) and overall survival. If the PFS endpoint is met, the company intends to file a Biologics License Application and seek approval for CMB305 for the treatment of synovial sarcoma.
G100 is being evaluated in multiple clinical trials, including as a monotherapy with local radiation in a completed phase I study in patients with MCC and an ongoing investigator-sponsored trial in patients with sarcoma. It is also being developed as a monotherapy and combination therapy in patients with follicular non-Hodgkin Lymphoma in a randomized phase Ib/II study. The monotherapy phase Ib portion of the trial is evaluating G100 with local radiation and the randomized phase II portion of the trial is evaluating G100 with local radiation and in combination with the anti-PD-1 agent, Keytruda, pursuant to a collaboration with Merck (NYSE:MRK) .
A potential approval of these pipeline candidates will be a boost for the company.
Immune Design’s shares have underperformed the Zacks Investment Research
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