From left, Darren Benedick and Mark Slatcoff set up the 80-L bioreactor for rhIL-15 production.

Cancer immunotherapy is a type of treatment in which the body’s own immune system is used to attack and kill cancer cells or keep them from spreading. To date, the immunotherapy agent interleukin-2 (IL-2) has been approved by the U.S. Food and Drug Administration for treating certain types of melanoma and kidney cancer.1

IL-2 therapy, however, carries a high degree of risk because large doses of IL-2 are required to maintain effectiveness. Such high dosages may result in serious, even life-threatening, side effects. Researchers, therefore, have been searching for alternative immunotherapeutic agents that will be equally effective and safer.1

Interleukin-15 (IL-15) is one such agent that is under study at the National Institutes of Health (NIH) and elsewhere. IL-15 has longer-lasting effects than IL-2, so it may be administered in smaller dosages. Moreover, IL-15 stimulates the production of “memory” immune cells, which can recognize and continue attacking cancer cells.1

BDP Produces Clinical-Grade rhIL-15

The Biopharmaceutical Development Program (BDP) has produced several grams of clinical-grade recombinant human interleukin 15 (rhIL-15) for various clinical indications. rhIL-15 is a T-cell growth factor that is proposed to have clinical applications that are similar to, but potentially safer than, IL-2.

BDP scientists developed an efficient and scalable manufacturing process utilizing the latest process analytical techniques and bioprocess strategies to ensure a very high product quality and yield.

BDP’s rhIL-15 is currently supporting three investigational studies for cancer therapy. The inaugural study, sponsored by Thomas Waldmann, M.D., at the National Cancer Institute (NCI) Center for Cancer Research, has been accruing melanoma and renal cancer subjects for the past year and is progressing as scheduled. The purpose of this first-in-human study is to determine whether rhIL-15 is a safe and effective treatment for these two cancers, and to study how rhIL-15 is processed in the human body after each dosage, as well as how it affects the cancer being treated.2

Two additional studies were recently initiated. One, sponsored by Steven Rosenberg, M.D., at NIH, involves rhIL-15 stimulation of tumor-attacking immune cells (lymphocytes) that are transferred to subjects following chemotherapy for metastatic melanoma. The other study, sponsored by Jeffery Miller, M.D., at the University of Minnesota, uses rhIL-15 to stimulate a specific kind of immune cells, known as natural killer cells, in stem cell transplantation in leukemia patients.

Soon, the Cancer Immunotherapy Trials Network will initiate a multi-site study involving subcutaneous (below the skin) rhIL-15 administration in cancer patients. All of these studies will examine different ways to safely administer rhIL-15 and achieve a therapeutic response. Specific information on these clinical trials can be found at

BDP is producing rhIL-15 for NCI at Frederick National Laboratory for Cancer Research. Information on the availability of rhIL-15 for research may be obtained from Jason Yovandich, Ph.D., program director, Biological Resources Branch, NCI.

Full article from SAIC-Frederick Inc.'s newsletter News & ViewsWritten by Vinay Vyas, Guest Writer, and Nancy Parrish, Staff Writer