Resimmune is an investigational treatment for cutaneous T-cell lymphoma (CTCL). It is being developed by Angimmune, a clinical stage biotechnology company investigating the use of immunosuppressive drugs in the treatment of T-cell related diseases, metastatic melanoma, and autoimmune diseases.
CTCL is a slow-growing form of cancer in which some of the body’s white blood cells become cancerous. These abnormal cells, called T-cells, whose job is to fight infections and other abnormal cells in the body, are drawn to the skin and some are deposited there. CTCL then can progress to the blood, lymph nodes, and other parts of the body.
Systemic therapies for advanced CTCL include radiation and various forms of chemotherapy. However, the disease does not always respond to these therapies.
How Resimmune works
Resimmune is an anti-CD3 immunotoxin with the potential to block the formation of new tumors.
It is composed of a ligand (a substance that binds to a biomolecule to achieve a biological purpose) linked to a toxin that inactivates protein synthesis. The ligand is made of two antibody fragments that can recognize a component of the T-cell receptor CD3ε, which exists on the vast majority of cancerous T-cells. This is fused to parts of the diphtheria toxin (DT390).
The ligand (or antibody) directs the molecule to the surface of the lymphoma cell, where the toxin exerts its activity-inhibiting protein synthesis and leading to cell death.
Resimmune in clinical trials
A Phase 2 clinical trial (NCT00611208) sponsored by Angimmune that lasted six years, evaluated the effect of Resimmune in 25 patients with cutaneous T-cell lymphoma. The drug led to complete remission in four patients, which lasted for more than 72 months in some cases, and partial remission in five patients, which lasted between three and 14 months. The most common adverse events caused by the drug were fever, chills, low blood pressure, edema, and abnormally low levels of albumin and phosphate in the blood.
Another Phase 2 clinical trial (NCT02943642), also sponsored by Angimmune, started in January 2017, to study the safety and effectiveness of Resimmune in comparison to oral Zolinza (vorinostat), another cancer medicine, in patients with mycosis fungoides, which is the most common type of CTCL. The estimated completion date of this trial is May 2020.
Resimmune was granted fast track designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides.
The therapy also has potential applications in other T-cell blood cancers, T-cell driven autoimmune diseases, including multiple sclerosis, and other cancers.
With Resimmune being administered in four days versus multiple courses of other treatments, the drug has the potential to reduce both treatment time and expense.
The safety and effectiveness of Resimmune have not been established yet.
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