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The companies have formed a collaboration to develop a novel human recombinant protein as a therapeutic candidate against COVID-19.
On May 20, 2020, Airway Therapeutics, a biopharmaceutical company developing a new class of biologics to treat respiratory and inflammatory diseases, and Celonic Group, a contract development and manufacturing organization (CDMO) specializing in advance therapy medicinal products (ATMPs) and mammalian cell line-expressed biotherapeutics, announced that they have formed a collaboration to produce the novel human recombinant protein, AT-100 (rhSP-D), as a therapeutic candidate against COVID-19.
Under the agreement, Celonic will be responsible for process optimization and good manufacturing practice (GMP) manufacturing of AT-100 for clinical study. Production of the product candidate is expected to begin in June 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 stated in a company press release. Airway has previously filed a pre-investigational new drug (IND) submission with FDA for AT-100 as a preventive treatment for bronchopulmonary dysplasia in pre-term infants, with an IND filing expected in the third quarter of 2020 and plans to enter the clinic in late 2020.
Celonic’s human cell line expression system includes fully human glycosylation, making it a good platform for high-yield GMP production of difficult-to-express complex molecules, such as bispecific antibodies, fusion proteins, antibody fragment, and blood factors. The company offers perfusion continuous cell culture manufacturing-for both Chinese hamster ovary and human cell lines-at a 1000-L bioreactor scale.
“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,” said Marc Salzberg, MD, president and CEO of Airway, in the press release. “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.”
“At Celonic, we are excited and proud to work with Airway and join the fight against this worldwide pandemic,” said Konstantin Matentzoglu, PhD, CEO of Celonic, in the press release. “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.”
“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,” added Alan Wolk, chief financial and operating officer of Airway, in the press release. “Airway is inspired, engaged, and enthusiastic to contribute in the effort to overcoming the pandemic through the therapeutic potential of AT-100.”
Source: Airway Therapeutics