On May 20, 2020, Airway Therapeutics and Celonic Group 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 Jun. 2020.

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.

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.

AT-100 is a novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response to break the cycle of injury and inflammation. Airway is focused on advancing AT-100 as a potential therapeutic for very serious COVID-19 patients and for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants. AT-100’s anti-inflammatory and anti-infective properties also make it a potential treatment for other respiratory diseases such as influenza, respiratory syncytial virus (RSV) and inflammatory diseases inside and outside the lung. Airway has filed a pre-IND submission with the FDA for AT-100 as a preventative treatment for BPD.

Airway Therapeutics, based in Cincinnati, OH, is a biopharmaceutical company developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, beginning with the most vulnerable populations. The company is advancing the novel recombinant human protein rhSP-D, an engineered version of an endogenous protein that reduces inflammation and infection in the body while modulating the immune response. AT-100 is Airway’s first candidate in development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants.