Encouraging Pre-Clinical Data from Celldex - Analyst Blog

Celldex Therapeutics, Inc. CLDX announced encouraging results from preclinical studies on its antibody drug conjugate, CDX-014. The studies evaluated the anti-tumor activity of CDX-014 against a variety of cell lines.

With proof-of-concept preclinical data in its hands, Celldex intends to commence phase I studies on CDX-014 for renal cell carcinoma and other TIM-1 (a molecule highly expressed in renal and ovarian cancers) expressing tumors in 2015.

Meanwhile, Celldex's lead pipeline candidates are rindopepimut and glembatumumab vedotin which are in registration studies for EGFRvIII (v3) positive glioblastoma (brain cancer) and triple negative breast cancer, respectively.

Patient enrollment for the study on rindopepimut should be completed by mid-2014. Celldex is also enrolling patients for the phase II ReACT study on rindopepimut for recurrent glioblastoma. Data from this study is expected by the end of this year.

Both these candidates received fast track designation from the U.S. Food and Drug Administration (FDA).

The company has several other early-stage candidates in its pipeline. Celldex plans to initiate new studies on oncology candidate varlilumab in combination with various agents. The company is also supporting an investigator-sponsored study on CDX-301 and Hiltonol for the treatment of low-grade B-cell lymphomas. A pilot study on CDX-301 alone and in combination with Mozobil is slated to commence this year for hematopoietic stem cell transplantation.

Celldex carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Amgen Inc. AMGN, Alkermes plc ALKS and Alexion Pharmaceuticals, Inc. ALXN. All these stocks carry a Zacks Rank #1(Strong Buy).