CMC ICOS Biologics 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. Due to its robust immunostimulatory capacity for NK and T cells, Altor is developing ALT-803 for oncology and infectious disease indications. The molecule is currently part of an extensive 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 (iNHL) and non-small cell lung cancer.

“We selected CMC Biologics as our manufacturing partner for ALT-803 because of their demonstrated technical expertise manufacturing complex cell culture processes, including fusion proteins,” said Hing Wong, chief executive officer, Altor. “The successful transfer and manufacture of ALT-803 is vital to meeting our timelines as we advance our molecule towards pivotal studies. Furthermore, we are also exploring new applications for ALT-803 based combination approaches with other immunotherapies to further boost the immune response in patients with cancer or infectious diseases.”

Gustavo Mahler, president and chief executive officer, CMC Biologics,” said, “We are delighted that Altor has selected CMC Biologics as their contract manufacturing organization (CMO) for ALT-803. CMC has a great deal of experience manufacturing Phase 3 candidates, and we are equipped to support potential scale-up needs utilizing our Bioreactor 3PACK and 6PACK facilities, should the demand for ALT-803 escalate beyond the current projected batch quantities. We look forward to working with the Altor team to successfully move this molecule to the next phase.”