Celldex (CLDX) Initiates Phase II Study On Cancer Candidate
Zacks Investment Research | Nov 19, 2017 09:33PM ET
Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced the initiation of a phase II study on its human monoclonal antibody, CDX-3379 in patients with advanced head and neck squamous cell carcinoma ("HNSCC").
With no approved products in its portfolio, investor focus remains on the progress of Celldex’s pipeline candidates.
Shares of the company were up more than 2% on Friday following the news. However, Celldex’s shares were down 17.8% so far this year, underperforming the industry ’s gain of 1.5% in that period.
The phase II study will evaluate CDX-3379 in combination with Eli Lilly’s (NYSE:LLY) Erbitux in patients with advanced HNSCC who are Erbitux resistant and previously treated with an anti-PD1 checkpoint inhibitorThe company believes that the patient population being evaluated in the study has limited availability of treatment options and a particularly poor prognosis. The study will continue the treatment till progression of the disease starts or patients become intolerant to the combination therapy. The primary objective of the study is to achieve objective response rate.
The two-stage study will enroll 13 patients in the first stage and initiate the second stage upon achieving partial or complete response in at least one patient.
We remind investors that a completed phase Ib study on the combination therapy had shown promising anti-tumor activity in HSNCC patients including a durable complete response in a single patient whose disease had progressed on Erbitux monotherapy.
Celldex is also progressing well with its lead pipeline candidate, glembatumumab vedotin, which is being evaluated in a phase IIb study in patients with triple negative breast cancer and in a phase II study in melanoma patients. The company is also evaluating the candidate in combination with Bristol-Myers’s (NYSE:BMY) Opdivo or Merck’s (NYSE:MRK) Keytruda in two separate cohorts in its melanoma study.
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