Altor BioScience and CMC Biologics Announce Agreement for Manufacture and Validation of Altor’s IL-15 Superagonist Molecule, ALT-803, for use in Phase 3 Clinical Trials
April 13, 2017
CMC BIOLOGICS, NEWS
CMC ICOS Biologics, Inc. (“CMC Biologics”), a global leader in clinical and commercial manufacturing of therapeutic proteins, and Altor BioScience Corporation (“Altor”), a leading developer of novel cytokine-based immunotherapeutics for cancer and infectious diseases, today announced that they 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 IL15Rα/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 C. Wong, Ph.D., Chief Executive Officer of 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.”
“We are delighted that Altor has selected CMC Biologics as their contract manufacturing organization for ALT-803” stated Gustavo Mahler, Ph.D., President & Chief Executive Officer of CMC Biologics. “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.”
About CMC Biologics
CMC Biologics, a wholly-owned subsidiary of Asahi Glass Company (AGC) is one of the industry leading CMOs in reliability, technical excellence, and quality — Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scaleup and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical, and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation development, and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbio.com.
About Altor BioScience Corporation
Altor is a privately held, clinical-stage biopharmaceutical company developing novel immunotherapeutics for the treatment of cancer and infectious diseases. Altor’s engineered cytokine technology platforms are centered on the immunostimulatory properties of the cytokines IL-15 and IL-2. These cytokines provide essential links between the innate and adaptive arms of the immune system and induce the activation, proliferation, and persistence of NK and T cells, which are critical in the body’s defense against cancer and infection. Altor is leveraging its extensive network of research and clinical collaborations, including leading cancer institutes and universities, toward actively exploring the potential clinical utilities of product candidates ALT803 and ALT-801 against cancer and infectious diseases. In various experimental models, ALT-803 and ALT-801 exhibit potent immunostimulatory activity when administered in combination with other types of therapeutic agents. Altor is distinctively positioning its immunotherapeutic platform to be employed as the backbone therapy in next-generation combination immunotherapy approaches. For more information, please visit www.altorbioscience.com/