Cancer Current Trials

Celldex has four programs currently under clinical evaluation for the therapy of cancer.

• Rindopepimut (CDX-110) - Clinical Program for Malignant Glioblastoma (GB)
  Our lead clinical development program, rindopepimut, is an immunotherapy that targets the tumor specific oncogene called EGFRvIII, an activated mutation of the epidermal growth factor receptor (EGFR), a protein that has been well validated as a target for cancer therapy. While many different epithelial tumors express this antigen, GB has a particularly poor prognosis and is our primary indication at this time. A Phase 3 confirmatory trial in newly diagnosed, resected GB and a Phase 2 trial in recurrent GB are underway.
• CDX-011 - Clinical Program for Locally Advanced or Metastatic Breast Cancer and Unresectable Stage III or Stage IV Melanoma
  Our lead antibody-drug conjugate (ADC), CDX-011, is in Phase 2b development for the treatment of locally advanced or metastatic breast cancer. CDX-011 has been shown to be safe and active, with observed objective responses, in two Phase 1/2 trials in locally advanced or metastatic breast cancer and stage III or IV melanoma. CDX-011 targets glycoprotein NMB, a protein overexpressed on the surface of cancer cells in these and other types of cancers.
• CDX-1401 - Clinical Program in NY-ESO-1 Expressing Malignancies
  Our second APC Targeting Technology™ product candidate, CDX-1401, is in Phase 1/2 development for the treatment of cancers known to express NY-ESO-1, including cancers of the bladder, breast, ovary, non-small cell lung cancer, myeloma, sarcoma and melanoma. This product is intended to selectively deliver the NY-ESO-1 antigen to Antigen-Presenting Cells (APCs) for generating robust immune responses against cancer cells expressing NY-ESO-1. Initial data from this ongoing study confirm safety and immunogenicity even in patients with advanced cancer who have received multiple prior therapies.
• CDX-1127 - Clinical Program for Hematologic Malignancies and Solid Tumors
  CDX-1127 is an agonist anti-CD27 monoclonal antibody (mAb) that is expected to activate CD27 expressing T cells in the context of T cell receptor stimulation. In addition to the immune enhancing properties of CDX-1127, the mAb may also provide direct therapeutic effects against tumors with CD27 expression. CDX-1127 is in Phase 1 development for the treatment of B cell hematologic malignancies known to express CD27 including, but not limited to, chronic lymphocytic leukemia (CLL), Burkett’s lymphoma, mantle cell lymphoma, primary lymphoma of the central nervous system and marginal zone B-cell lymphoma and solid tumors that may be more likely to be sensitive to immune therapy: metastatic melanoma, renal cell carcinoma, hormone-refractory prostate adenocarcinoma, ovarian cancer, colorectal adenocarcinoma or non-small cell lung cancer (NSCLC).
• CDX-301 - Clinical Program for Treatment of Cancer Patients Requiring Hematopoietic Stem Cell Transplantation (HSCT)
  CDX-301 is soluble, recombinant human Fms-like tyrosine kinase-3 ligand (Flt3L) that acts by uniquely binding Fms-like tyrosine kinase-3 (Flt3, CD135) which is expressed on hematopoietic stem cells (HSC), early progenitor cells, immature thymocytes, and steady state dendritic cells, resulting in the proliferation, differentiation, development and mobilization of these cells in the bone marrow, peripheral blood, and lymphoid organs. Prior development of this program was performed by Immunex, Inc. demonstrating the safety and biologic activity in early clinical studies. A Phase 1 trial in healthy volunteers is underway to support subsequent trials for allogeneic HSCT. Celldex will eventually pursue additional indications potentially to include cancer therapy, ex vivo expansion of dendritic cells for cancer immunotherapy, radiation countermeasures, and burn management.