Why it is profiled?Scheduled to present trial results of its investigational drugs at the ASCO (American Society of Clinical Oncology) conference in June.
Celldex Therapeutics Inc. (CLDX) is a biotechnology company focused on developing antibody-based combination immunotherapies for the treatment of cancer and other difficult-to-treat diseases. RTTNews had alerted readers to the stock last December when it was trading around $4. The stock, which has had a steady run for the year-to-date period, rising nearly 60%, currently trades over $7.
The company has a well-stocked pipeline in varying stages of development. CDX-110 vaccine is Celldex' lead product candidate that is under phase II trials in patients with newly diagnosed glioblastoma multiforme, or GBM, one of the most aggressive forms of brain cancer. CDX-110 is an immunotherapy that targets the tumor-specific growth promoter EGFRvIII that can be expressed by GBM.
The company is scheduled to present data from the third phase II study of CDX-110 at the ASCO. The phase II study, dubbed ACT III, is being conducted in collaboration with Pfizer Inc. (PFE) with the objectives of investigating the anticancer activity , impact on survival, and safety of CDX-110 when administered during a 12 month course of maintenance temozolomide chemotherapy (standard of care treatment) and then continuing until disease progression.
In the first phase II study, dubbed ACTIVATE, patients with newly diagnosed GBM were administered CDX-110 vaccine alone, and in the second phase II study dubbed ACT II, patients were administered CDX-110 plus temozolomide. The study results of ACTIVATE and ACT II were presented last May, which demonstrated that vaccination with CDX-110 may be able to improve time to tumor recurrence and overall survival when used in patients with newly-diagnosed GBM.
The company is also scheduled to present final data from phase I/II study of CDX-011 in patients with melanoma. According to the initial data from phase II study of CDX-011 in melanoma, which were presented last June, the median overall progression free survival was 4.4 months. Tumor shrinkage was observed in 58% of patients, and 20 patients had best response of stable disease.
CDX-011 is a fully-human monoclonal antibody-drug conjugate that targets GPNMB (glycoprotein NMB), also known as osteoactivin, a protein overexpressed on the surface of cancer cells, including melanoma, breast cancer and gliomas. Apart from melanoma, Celldex is evaluating CDX-011 in breast cancer indication too.
Last December, the company reported positive results from a mid-stage study of CDX-011 in patients with advanced breast cancer. A randomized phase IIb controlled study in patients with advanced breast cancer that express GPNMB is expected to be initiated in the third quarter.
The other compounds in clinical development include CDX-1401 and CDX-1307.
CDX-1307 is under development for the treatment of epithelial tumors such as colorectal, pancreatic, bladder, ovarian and breast cancers. The company expects to initiate a randomized phase IIb controlled study in patients with newly diagnosed invasive bladder cancer this quarter. (Q2).
CDX-1401 is being evaluated for the treatment of malignant melanoma and a variety of solid tumors which express the proprietary cancer antigen NY-ESO-1. A dose-escalating phase 1/2 clinical trial of CDX-1401 was initiated last September and the company expects to present the trial update by the end of this year.
Celldex also has a number of preclinical compounds - CDX-301, which has a potential for various transplant settings as a stem cell mobilizing agent, CDX-1127 and CDX-014 for cancers and CDX-1189 for renal disease.
The company has one commercial product Rotarix for rotavirus infection marketed worldwide by its partner GlaxoSmithKline plc (GSK). Rotavirus is a major cause of diarrhea and vomiting in infants and children.
At year end 2009, Celldex had total cash of $82.5 million, sufficient to fund operations into 2012.
With important upcoming events, Celldex may be a stock worth watching.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.