Celldex Therapeutics (CLDX)
Small phase II studies have shown promising efficacy from Celldex's cancer immunotherapy "vaccine" CDX-110 in patients with glioblastoma, an aggressive form of brain cancer. What's needed next is a large, well-designed phase III study of CDX-110 in patients with glioblastoma that can more conclusively demonstrate the drug's ability to help patients live longer.And therein lies the risk in Celldex. Pfizer (PFE) gave up on Celldex and CDX-110, returning rights to the drug and forcing the company to design and fund a phase III study on its own. This study is expected to begin later this year but the wait for data will be long. Also pay attention to Celldex's second pipeline drug, CDX-011, which is being tested in a 120-patient, randomized, controlled phase IIb clinical trial in advanced breast cancer. (The study will enroll a large number of women with so-called "triple negative" disease, which is very difficult to treat.) Celldex expects enrollment to be complete by the end of the year, which should yield results in 2012.