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). DCVax-001 – HIV Vaccine: Celldex and Rockefeller University investigators are collaborating on an effort to develop a vaccine against HIV, the virus known to cause AIDS. The Rockefeller vaccine, called DCVax-001, is an APC-targeted vaccine consisting of a fusion protein of a human monoclonal antibody with specificity for the dendritic cell receptor, DEC-205 linked to an HIV antigen. This program has been funded through a grant from the Bill & Melinda Gates Foundation. The vaccine is currently being tested in a Phase 1 trial in healthy volunteers at Rockefeller University CDX-1135 – Renal Disease: Celldex is developing soluble Complement Receptor Type 1 (sCR1, TP10), a specific and potent inhibitor of complement activation, for use in renal disease indications. sCR1 has previously been in clinical trials and demonstrated a good safety profile and complement inhibition. sCR1 inhibits the classical, alternative and lectin pathways of complement at both early (C3 convertase) and late (C5 convertase) stages by down-regulating the activation of these cascades. sCR1 affects only activated complement and is not consumed, but can recycle in the inhibitory process. Certain rare renal diseases involve dysregulated complement and have been associated with mutations in complement proteins including Factor H and Membrane Cofactor Protein (MCP). sCR1 has similarities to Factor H and MCP in structure and function, thus providing strong support for its potential efficacy in these diseases. CDX-1189 - Renal Disease: Celldex is developing therapeutic human antibodies to a signaling molecule known as CD89 or Fcα receptor type I (FcαRI). CD89 is expressed by some white blood cells and leukemic cell lines, and has been shown to be important in controlling inflammation and tumor growth in animal models. Celldex has proprietary, fully human antibodies to CD89 in preclinical development. Depending upon the specific antibody used, anti-CD89 antibodies can either be activating and thus stimulate immune responses, or down-regulating and anti-inflammatory. Celldex hat ganz schön viele Aktivitäten laufen - viele im Bereich der Immunotherapie. Am interessantesten sind natürlich die weiter fortgeschrittenen Programme Phase III gegen eine besonders bösartige Form des Hirnturmos (glioblastoma) und das Phase IIb Programm (CDX-011 is a fully-human monoclonal antibody-drug conjugate (ADC) gegen Brustkrebs. In beiden Fällen gibt es bereits vielversprechende klinische Daten. |