Celldex Therapeutics’ CDX-1401, CDX-301 Combination Generates Potent NY-ESO-1 Immune Responses in Patients with Melanoma

Excerpt:

“Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today results from a Phase 2 clinical study evaluating CDX‑1401 and CDX‑301 in patients with malignant melanoma, which was conducted by the Cancer Immunotherapy Trials Network (CITN) under a Cooperative Research and Development Agreement (CRADA) between Celldex and the Cancer Therapy Evaluation Program of the National Cancer Institute. CDX‑1401 is an NY‑ESO‑1-antibody fusion protein for immunotherapy, and CDX‑301 (recombinant human Flt3 ligand) is a potent hematopoietic cytokine that uniquely expands dendritic cells and hematopoietic stem cells. Results from the study were presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago in a poster titled ‘A Phase 2, Open-label, Multicenter, Randomized Study of CDX‑1401, a Dendritic Cell Targeting NY‑ESO‑1 Vaccine, in Patients with Malignant Melanoma Pre-Treated with CDX‑301, a Recombinant Human Flt3 Ligand.’ ”

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Celldex Therapeutics Announces Initiation of Phase 1/2 Study of Varlilumab in Combination with Ipilimumab and CDX-1401 in Metastatic Melanoma

“Celldex Therapeutics, Inc. (CLDX) today announced the initiation of a Phase 1/2 safety pilot and expansion study examining the investigational combination of varlilumab and ipilimumab (Yervoy(R); Bristol-Myers Squibb) in patients with Stage III or IV metastatic melanoma. Varlilumab is Celldex’s fully human monoclonal antibody that targets CD27, a critical co-stimulatory molecule in the immune activation cascade. Ipilimumab, a recombinant, human monoclonal antibody that blocks CTLA-4, is FDA approved for the treatment of unresectable or metastatic melanoma. In the Phase 2 portion of the study, patients with tumors that express NY-ESO-1 will also receive CDX-1401, Celldex’s off-the-shelf antibody-based dendritic cell vaccine that targets tumors expressing the NY-ESO-1 oncoprotein.

“The three agents in this study were specifically selected because they uniquely intervene at key points of immune regulation and because Celldex has observed enhanced activity in preclinical studies when varlilumab is combined with either checkpoint inhibitors or with vaccines. In addition, this study will also build on previous clinical data from the CDX-1401 experience that suggests that CDX-1401 may predispose patients to better outcome on checkpoint inhibitors, including ipilimumab. “We believe sophisticated combination approaches centered on immunotherapy hold significant promise for the treatment of cancer and, to this end, are committed to exploring novel combinations across a broad array of mechanisms and indications. This latest trial marks the third Phase 1/2 combination study that varlilumab has entered and the first three-drug combination study,” said Thomas Davis, MD, Executive Vice President and Chief Medical Officer of Celldex Therapeutics.”


New Cancer Vaccine Approach Directly Targets Dendritic Cells

“Celldex Therapeutics announced today that final data from its Phase 1 study of CDX-1401 in solid tumors, including long-term patient follow-up, have been published inScience Translational Medicine. The data demonstrate robust antibody and T cell responses and evidence of clinical benefit in patients with very advanced cancers and suggest that CDX-1401 may predispose patients to better outcomes on subsequent therapy with checkpoint inhibitors. CDX-1401 is an off-the-shelf vaccine consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The vaccine is designed to activate the patient’s immune system against cancers that express the tumor marker NY-ESO-1. While the function of NY-ESO-1 continues to be explored, references in the literature suggest that its expression might reflect the acquisition of properties that cancers find useful, such as immortality, self-renewal, migratory ability and the capacity to invade.”

Editor’s note: Cancer vaccines like CDX-1401 are a type of immunotherapy, meaning that they boost a patient’s own immune system to fight cancer. CDX-1401 is able to attack tumor cells because the tumor cells have a molecule called NY-ESO-1 that CDX-1401 recognizes. We recently published a story about another treatment that is meant for patients whose tumors have NY-ESO-1. To learn more about how patients can use molecular testing to see if particular treatments might work for them, click here.


New Cancer Vaccine Approach Directly Targets Dendritic Cells

“Celldex Therapeutics announced today that final data from its Phase 1 study of CDX-1401 in solid tumors, including long-term patient follow-up, have been published inScience Translational Medicine. The data demonstrate robust antibody and T cell responses and evidence of clinical benefit in patients with very advanced cancers and suggest that CDX-1401 may predispose patients to better outcomes on subsequent therapy with checkpoint inhibitors. CDX-1401 is an off-the-shelf vaccine consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The vaccine is designed to activate the patient’s immune system against cancers that express the tumor marker NY-ESO-1. While the function of NY-ESO-1 continues to be explored, references in the literature suggest that its expression might reflect the acquisition of properties that cancers find useful, such as immortality, self-renewal, migratory ability and the capacity to invade.”

Editor’s note: Cancer vaccines like CDX-1401 are a type of immunotherapy, meaning that they boost a patient’s own immune system to fight cancer. CDX-1401 is able to attack tumor cells because the tumor cells have a molecule called NY-ESO-1 that CDX-1401 recognizes. We recently published a story about another treatment that is meant for patients whose tumors have NY-ESO-1. To learn more about how patients can use molecular testing to see if particular treatments might work for them, click here.