First-in-Human CRISPR Immunotherapy Would Target PD-1

Excerpt:

“At a time when PD-1 inhibitors are dominating the immunotherapy field, a team of researchers is seeking to use groundbreaking CRISPR gene editing technology for the first time in human beings to create an engineered T-cell agent that would knock out the gene that controls the immune checkpoint’s activity.

“Plans for the complex therapy call for taking NY-ESO-1, a peptide-based form of adoptive immunotherapy already in clinical trials, and disrupting the activity of the PDCD1 gene that encodes PD-1 as well as the endogenous TRAC and TRBC genes, which control T-cell receptor (TCR) alpha and beta, respectively.

“The goal would be to enhance the immune response with NY-ESO-1 by eliminating genomic drivers that hamper T-cell proliferation and function, University of Pennsylvania (UPenn) researchers said in describing the proposed study before a National Institutes of Health (NIH) panel on June 21.”

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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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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.


Using a Person's Own Immune System to Fight Cancer: Phase I Clinical Trial of New Immunotherapy Beginning

“Moffitt Cancer Center has initiated a phase I clinical trial for a new immunotherapy drug, ID-G305, made by Immune Design. Immunotherapy is a treatment option that uses a person’s own immune system to fight cancer. It has several advantages over standard cancer therapies, including fewer side effects and an overall better tolerability. It tends to be most effective in patients who have smaller, localized tumors that have not spread to distant sites.”

Editor’s note: This treatment looks for and targets cells that have the protein NY-ESO-1. Only 10-15% of tumors have NY-ESO-1, and patients’ tumors must test positive for NY-ESO-1 in order for the patients to enroll in the trial. Learn more about immunotherapy and clinical trials here.


Using a Person's Own Immune System to Fight Cancer: Phase I Clinical Trial of New Immunotherapy Beginning

“Moffitt Cancer Center has initiated a phase I clinical trial for a new immunotherapy drug, ID-G305, made by Immune Design. Immunotherapy is a treatment option that uses a person’s own immune system to fight cancer. It has several advantages over standard cancer therapies, including fewer side effects and an overall better tolerability. It tends to be most effective in patients who have smaller, localized tumors that have not spread to distant sites.”

Editor’s note: This treatment looks for and targets cells that have the protein NY-ESO-1. Only 10-15% of tumors have NY-ESO-1, and patients’ tumors must test positive for NY-ESO-1 in order for the patients to enroll in the trial. Learn more about immunotherapy and clinical trials here.


Using a Person's Own Immune System to Fight Cancer: Phase I Clinical Trial of New Immunotherapy Beginning

“Moffitt Cancer Center has initiated a phase I clinical trial for a new immunotherapy drug, ID-G305, made by Immune Design. Immunotherapy is a treatment option that uses a person’s own immune system to fight cancer. It has several advantages over standard cancer therapies, including fewer side effects and an overall better tolerability. It tends to be most effective in patients who have smaller, localized tumors that have not spread to distant sites.”

Editor’s note: This treatment looks for and targets cells that have the protein NY-ESO-1. Only 10-15% of tumors have NY-ESO-1, and patients’ tumors must test positive for NY-ESO-1 in order for the patients to enroll in the trial. Learn more about immunotherapy and clinical trials here.