Celldex Therapeutics, Inc. (CLDX) announced the commencement of a pilot study on CDX-301, a potent hematopoietic cytokine, for the mobilization and transplantation of allogeneic hematopoietic stem cells in patients with hematological malignancies undergoing hematopoietic stem cell transplantation (HSCT). The shares of the company were up 1.9% on the news.
The open-label, pilot study will evaluate the safety and tolerability of CDX-301 (also known as FMS-like tyrosine kinase-3 ligand or Flt3L) alone or in combination with Mozobil. Celldex intends to enroll up to 36 patients or 18 recipient/donor pairs aged between 18 and 65 years, across two sequentially enrolled cohorts, in approximately 10 clinical trial sites in the U.S. The study will include patients (recipients) with specified hematologic malignancies (acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, chronic myelogenous leukemia, non-Hodgkin's lymphomas and chronic lymphocytic leukemia) and human leukocyte antigen (HLA) sibling-matched healthy volunteers (donors).
Meanwhile, preclinical data revealed that the combination of CDX-301 and Mozobil increased hematopoietic stem cell mobilization and improved transplantation of mobilized cells.
We remind investors that Celldex had licensed CDX-301 from Amgen (AMGN) in Mar 2009.
We note that Celldex completed a phase I study on CDX-301 in Feb 2013.
Apart from CDX-301, Celldex has several early-stage candidates in its pipeline including varlilumab (lymphoma/leukemia and solid tumors) and CDX-1401 (multiple solid tumors).
The company expects to complete patient enrolment in the phase III ACT IV study on one of its lead pipeline candidates, rindopepimut, for EGFRvIII (v3) positive glioblastoma multiforme (GBM) by the fourth quarter of 2014. Another lead candidate in Celldex’s pipeline, glembatumumab vedotin (triple negative breast cancer and melanoma), is presently in phase II development.
We expect investor focus to remain on pipeline updates from the company.
Celldex is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Cambrex Corporation (CBM) and Gilead Sciences Inc. (GILD). Both stocks carry a Zacks Rank #1 (Strong Buy).
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