FDA gives MD Anderson the green light to test skin cancer treatment on humans – Houston Chronicle

MD Anderson Cancer Center and a Massachusetts biotechnology company received clearance from the Food and Drug Administration to begin testing a new cell therapy treatment on humans for metastatic melanoma, the most serious type of skin cancer. Clinical trials will begin next month.

The treatment, developed with Obsidian Therapeutics of Cambridge, Mass., aims to avoid life threatening complications associated with similar cell therapies.

It is a type of tumor infiltrating lymphocyte (TIL) therapy, in which doctors remove tissue from the tumor, isolate the cancer fighting T cells, and infuse in the patient to concentrate their attacks on the cancer cells and reduce the tumors. Typically, patients also receive an infusion of interleukin-2, which promotes the growth of those T cells, but can cause heart, lung and kidney dysfunction.

MD Anderson and Obsidian researchers hope they found a technique that is more effective without harsh side effects.

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The researchers modified the T cells to produce their own interleukin, but a slightly different version known as interleukin-15. They modified the T cells so they can be activated by a pill called Acetazolamide, which is used to treat a variety of diseases from from glaucoma to epilepsy.

If patients have adverse reactions to the treatment, they can be advised to stop taking the pill for a day or so. This wouldnt be the case with a one-time infusion.

It's an on-off switch, Dr. Rodabe Amaria, the lead researcher on the study said. Well be able to regulate the function of the T cell, which we really havent been able to do before in our T cell therapy.

Dr. Paul Wotton, chief executive officer of Obsidian Therapeutics, said he believes the therapy has the potential to significantly transform the treatment landscape for patients, bringing broader access to (tumor infiltrating lymphocyte therapy).

The cell therapies will be manufactured at CTMC, a joint venture between a San Diego biomanufacturer and MD Anderson to develop and manufacture cell therapies, aiming to build a niche in biologic treatments.

becca.carballo@chron.com

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FDA gives MD Anderson the green light to test skin cancer treatment on humans - Houston Chronicle