Rocapuldencel-T (AGS-003) is an immunotherapy being developed by Argos Therapeutics. It is currently being investigated as a treatment for renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and bladder cancer.

How Rocapuldencel-T works

Rocapuldencel-T aims to provide a precision cancer vaccine that specifically targets tumor cells.

The immune system recognizes antigens, substances that are not normally produced by the body, which are picked-up by specialized cells called antigen presenting cells (APCs) such as the dendritic cells. These cells present the antigens to another type of immune cell called a T-cell, stimulating them to attack and kill cells expressing that antigen. Some T-cells become “memory T-cells,” storing the antigen so that the immune system can “remember” the signs of a disease that possess that particular antigen and quickly act against it the next time it is encountered.

Cancer can be caused by mutations that lead to the overproduction of certain proteins. However, the pattern of mutations that causes this is unique to the individual, and this can affect how the cancer will respond to different treatments. These mutated proteins, or “neoantigens,” can be used as antigens by the immune system.

Argos uses its proprietary Arcelis platform, to produce personalized therapy. This involves collecting a tumor sample and some of the patient’s own dendritic cells. The dendritic cells are then activated with the mutated RNA, the molecule used to produce a protein, isolated from the tumor sample. When these cells are returned to the patient’s body by injection, they can stimulate the activation of T-cells primed to recognize and kill cells expressing the specific tumor-associated proteins.

This should result in a targeted reduction in the tumor, accompanied by the production of memory T-cells that can result in a long-term immune response against the cancer.

Rocapuldencel-T in clinical trials

Rocapuldencel-T has been studied in several completed and ongoing clinical trials.

The randomized Phase 3 ADAPT clinical trial (NCT01582672) is a key ongoing study. It is investigating Rocapuldencel-T plus standard of care compared to standard of care alone, in 462 patients with metastatic RCC at 107 sites across North America, Europe, and Israel. The estimated completion date for the trial is December 2018.

The trial was almost discontinued in February 2017, under recommendation by an independent data monitoring committee, because it had not reached the pre-determined target for overall survival by the interim data analysis. However, based on positive safety results, and evidence that a subset of patients may significantly benefit from the trial, the U.S. Food and Drug Administration (FDA) agreed with Argos’ plan to continue the trial.

Preliminary results from the trial were presented at the European Society for Medical Oncology (ESMO) 2017 Congress and suggested a significant association between overall survival and the number of memory T-cells produced in response to Rocapuldencel-T in the 114 patients analyzed.

Rocapuldencel-T also is being investigated as a treatment for NSCLC in a Phase 2 clinical trial (NCT02662634) sponsored by the GU Research Network in collaboration with the Cancer Research Network of Nebraska/Oncology Associates. The trial aims to assess the feasibility, safety, and effectiveness of the treatment in an estimated 20 patients alongside chemotherapy and/or radiation therapy. The trial is still recruiting participants at a site in Omaha, Nebraska.

Another clinical trial (NCT02944357) to test Rocapuldencel-T for the treatment of bladder cancer is planned by the Mayo Clinic, in collaboration with the National Cancer Institute. The trial has not started recruiting, but plans to enroll 20 participants to take part in the trial at the Mayo Clinic in Rochester, Minnesota.


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