The US Food and Drug Administration (FDA) has allowed Investigational New Drug (IND) application for Altor BioScience's interleukin-15 (IL-15) superagonist protein complex, ALT-803, against metastatic melanoma. IL-15 is a critical factor for the development, proliferation and activation of cellular immune responses and is considered one of the most promising cancer immunotherapeutic agents by the National Cancer Institute (NCI) of the National Institutes of Health.

In preclinical studies, ALT-803 has been shown to have significantly greater biological activity and a longer half-life compared to IL-15. The clinical trial of ALT-803 against incurable melanoma will be jointly sponsored by the Melanoma Research Alliance (MRA), Cancer Immunotherapeutic Trial Network and Altor. Dr Kim Margolin at the Fred Hutchinson Cancer Research Centre at the University of Washington will be the leading Principal Investigator of this first-in-human safety and efficacy clinical trial of ALT-803. Results from this trial will further guide Altor’s development of ALT-803 against other metastatic malignancies and viral infections. Patient enrollment for this trial is expected to start within two months.

Altor’s scientists have also revealed the novel T-cell-based anti-tumour mechanism of action of ALT-803 in experimental hematological tumour models. The results of these findings have been published in the May 15 issue of the peer-reviewed journal Cancer Research, the world’s most frequently cited cancer journal. Altor is currently collaborating with more than a dozen leading universities and research institutes to evaluate ALT-803 as an immunotherapeutic against various cancers and infectious diseases. The preliminary results from these collaborations are very encouraging and indicate that ALT-803 has substantial potency against a variety of solid tumors as well as HIV infection in experimental models.

Altor also announced that the US Patent and Trademark Office has issued a composition-of-matter patent covering ALT-803 (US Patent No. 8,507,222, entitled “Multimeric IL-15 Soluble Fusion Molecules and Methods of Making and Using Same”). Including this newly issued patent, Altor currently has five issued and allowed patents covering the composition, production and uses of ALT-803 and IL-15 derivatives.

Hing C Wong, Ph.D., Altor's founder and CEO commented, "We are very pleased that the FDA has allowed ALT-803 to enter trials in humans as a potential curative treatment for melanoma. A second clinical trial will be led by University of Minnesota Cancer Research Centre’s Jeffrey Miller, MD and Bruce Blazar, MD, who have also filed an Investigator IND application for patients with relapse of hematologic malignancy after allogeneic stem cell transplant. Based on our research studies, Altor also plans to file an IND application for use of ALT-803 in patients with refractory multiple myeloma. Altor’s IL-15 technology programs have received funding in the form of two Small Business Innovation Research grants from NCI and a James & Esther King Biomedical Research Grant from Florida’s Department of Health in collaboration with the MD Anderson Cancer Center, Orlando. We are thrilled by the wide recognition our IL-15 therapeutic approaches have received from these prestigious research institutes and foundations and are excited by the potential of ALT-803 as a potent anti-cancer agent and one-of-a-kind anti-viral medication. Our strong intellectual property portfolio will ensure Altor’s leading position in IL-15-based immunotherapeutic development.”

Altor is a privately held biotechnology company developing immunotherapies for treating cancer, viral infections, and inflammatory diseases based on its proprietary technology platforms.