Immune DesignIMDZ announced that it plans to initiate a pivotal phase III study to support a regulatory application for CMB305, in patients with synovial sarcoma. The company plans to start the study in mid-2018 and enroll 248 patients aged 12 years and older. The decision was based on discussions with the FDA.
The phase III study will evaluate CMB305 monotherapy in comparison to placebo in patients with NY-ESO-1+ locally advanced unresectable or metastatic synovial sarcoma, who have no evidence of progression after first-line chemotherapy. Patents will be randomized 1:1 to receive either CMB305 monotherapy or placebo. The study will have progression free survival (PFS) followed by overall survival (OS) as co-primary endpoints. If the study meets the PFS endpoint, the candidate may get approved by the FDA.
So far this year, Immune Design's stock has rallied 83.6% compared with the industry 's 2.5% gain.
CMB305 is one of the primary candidates being developed by Immune Design. CMB305 is being evaluated in multiple clinical trials in patients with soft tissue sarcoma (STS). CMB305 is being evaluated in STS patients both as monotherapy (phase I) and in combination with Roche's (RHHBY) Tecentriq (phase II). In August 2017, the company announced positive topline data from its interim analysis of the ongoing phase II study evaluating CMB305 in combination with Tecentriq or Tecentriq alone in 88 soft tissue sarcoma patients. The company had earlier received orphan drug designation for each component of CMB305 for STS in both the United States and the European Union.
Immune Design Corp. Price
Zacks Rank & Stocks to Consider
Immune Design carries a Zacks Rank #3 (Hold). Some better-ranked stocks in health care sector include Adaptimmune Therapeutics plc ADAP , Celgene Corporation CELG and Novo Nordisk A/S NVO holding a Zacks Rank #2 (Buy). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .
Adaptimmune's loss per share estimates have narrowed from $1.07 to 95 cents for 2017 and from $1 to 90 cents for 2018 over the last 60 days. The company delivered positive earnings surprises in three of the trailing four quarters, with an average beat of 2.56%. Share price of the company has increased 81% year to date.
Celgene's earnings per share estimates have moved up $9 to $9.02 for 2018. The company pulled off positive earnings surprises in all the trailing four quarters, with an average beat of 3.80%. The share price of the company has increased 18.2% year to date.
Novo Nordisk's earnings per share estimates have moved up $2.37 to $2.38 for 2017 and from $2.51 to $2.53 for 2018. The company pulled off positive earnings surprises in three of the trailing four quarters, with an average beat of 3.63%. The share price of the company has increased 37.6% year to date.
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