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Celldex's Glembatumumab Vedotin in Phase II for Melanoma

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Celldex Therapeutics, Inc. (CLDX) announced that it has commenced an open-label phase II study on one of its lead candidates, glembatumumab vedotin, for the treatment of patients suffering from unresectable stage III or IV melanoma.

In this study, Celldex will enroll patients who have received up to four anticancer therapies with one or no prior chemotherapy experience. Patients will be administered glembatumumab vedotin every three weeks until their disease progresses or they are found intolerant to the candidate. The primary endpoint of this study will evaluate the anticancer activity of glembatumumab vedotin in advanced melanoma in terms of the objective response rate.

Meanwhile, Celldex is also evaluating glembatumumab vedotin in the METRIC study for the treatment of metastatic triple negative breast cancer that over-expresses gpNMB. Under the amended protocol which now includes an expanded eligibility criteria for patient enrolment (as declared by Celldex at the time of announcing third-quarter 2014 results), the company expects to complete patient enrolment in this study by 2016. Glembatumumab vedotin enjoys fast track status for the treatment of advanced, refractory or resistant gpNMB-expressing breast cancer.

Additionally, another lead candidate at Celldex, rindopepimut, is in a phase III study (ACT IV) for the treatment of patients with surgically-resected, EGFRvIII-positive glioblastoma multiforme. Patient enrolment should be completed in the next few weeks with first interim data readout expected by mid-2015.

We note that Celldex is also planning to develop glembatumumab vedotin for other indications including squamous cell lung cancer, osteosarcoma, uveal melanoma and pediatric sarcoma. The company is on track to commence a phase II study on glembatumumab vedotin for squamous cell lung cancer following an assay optimization and validation, which is expected to be complete by the end of 2014.

We expect investors to focus on pipeline updates from the company.

Celldex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Biogen Idec Inc. (BIIB), ANI Pharmaceuticals, Inc. (ANIP) and AMAG Pharmaceuticals, Inc. (AMAG). While Biogen and ANIP carry a Zacks Rank #1 (Strong Buy), AMAG holds a Zacks Rank #2 (Buy).

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