CMC ICOS Biologics, Inc. and Altor BioScience Corporation have entered into a manufacturing agreement for the cGMP manufacturing of Altor’s ALT-803 molecule for use in Phase 3 clinical trials.
ALT-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15Rα/IgG1 Fc fusion protein. Preclinical studies have shown that ALT-803 simultaneously mobilizes both the innate and adaptive arms of the immune system to elicit rapid and durable responses against numerous cancers and virally-infected cells. The molecule is currently part of a development program, including ongoing clinical trials for the treatment of patients for various solid and hematological malignancies, such as non-muscle invasive bladder cancer, relapsed or refractory indolent B cell non-Hodgkin lymphoma and non-small cell lung cancer.