Airway Therapeutics, Inc., a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, and Celonic Group, a premium biopharmaceutical CDMO specialized in the development and production of Advance Therapy Medicinal Products (ATMPs) and mammalian cell line-expressed biotherapeutics, today announced a collaboration to produce the novel human recombinant protein AT-100 (rhSP-D) as a therapeutic candidate against COVID-19. Based on the agreement, Celonic will be responsible for process optimization and GMP manufacturing of AT-100 for clinical study. Production of AT-100 is expected to begin in June 2020.
AT-100 has shown great potential in addressing the inflammation and injury caused by serious respiratory diseases driven by infection but has never been produced for larger-scale clinical trial indications. Airway has dedicated significant time and resources to develop a manufacturing process for AT-100 - leading the path to clinical development. Given the urgency of the current pandemic, I am thrilled to establish this collaboration with Celonic, a leader in biologic manufacturing, to increase the scale of our production capabilities with the potential to meet the needs of patients."
Marc Salzberg, M.D., President and Chief Executive Officer of Airway
"At Celonic, we are excited and proud to work with Airway and join the fight against this worldwide pandemic," said Konstantin Matentzoglu, Ph.D., Chief Executive Officer of Celonic. "AT-100 has the potential to be a lifesaving treatment for COVID-19 patients until a vaccine is available, especially for those who are very seriously ill and in intensive care. Together, we have an opportunity to make a difference in the lives of patients at this time of great need."
AT-100 is an engineered version of an endogenous protein that has been shown in preclinical studies to reduce inflammation and infection in a range of bacterial and viral respiratory diseases by modulating the body's immune response. Airway has previously filed a pre-IND submission with the U.S. Food and Drug Administration (FDA) for AT-100 as a preventive treatment of the serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants, with an IND filing expected in Q3 and plans to enter the clinic in late 2020.
"I am proud of the combined team who worked tirelessly over several months to transfer the AT-100 manufacturing technology to Celonic in order to produce a scaled, GMP batch for clinical study in COVID-19 patients," said Alan Wolk, Chief Financial and Operating Officer of Airway. "Airway is inspired, engaged and enthusiastic to contribute in the effort to overcoming the pandemic through the therapeutic potential of AT-100."
Celonic's human cell line expression system, with fully human glycosylation, is an excellent platform for high-yield GMP production of difficult-to-express complex molecules such as bispecific antibodies, fusion proteins, antibody fragment and blood factors. Celonic is one of the unique global bio-solutions providers that can offer perfusion continuous cell culture manufacturing - for both CHO and human cell lines - at a large 1,000-liter bioreactor scale.
"The global battle against COVID-19 requires urgent and concerted efforts," said Vikalp Mohan, Chief Operating Officer of Celonic. "Swift strategic alignment and operational flexibility have been the hallmark of a highly collaborative partnership between Airway and Celonic. We are honored to have this opportunity to leverage our advanced perfusion cell culture manufacturing expertise to help realize the therapeutic potential of AT-100."