Airway Therapeutics Inc.,a biopharmaceutical company that spun out of the research of Jeffrey Whitsett of Cincinnati Children’s Hospital Medical Center, is developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases. They recently announced a partnership with Celonic Group, a premium biopharmaceutical CDMO specialized in the development and production of Advance Therapy Medicinal Produts (ATMPs) and mammalian cell line-expressed biotherapeutics, a collaboration to produce the novel human recombinant protein AT-100 (rhSP-D) as a therapeutic candidate against COVID-19. In this deal, Celonic will handle process optimization and GMP manufacturing of AT-100 for clinical study. The parties anticipate production of AT-100 to commence by June 2020.
TrialSite News‘ Investor Watch follows Airway Therapeutics and offers a brief breakdown of this recent announcement.
What is AT-100?
AT-100 is an engineered version of an endogenous protein that in preclinical research has shown positive evidence of reducing inflammation and infection in a range of bacterial and viral respiratory diseases by modulating the body’s immune response.
Prior to the COVID-19 crisis, the company, Airway Therapeutics (Airway), filed a pre-IND submission with the U.S. Food and Drug Administration (FDA) for AT-100 as a preventive treatment for serious respiratory disease bronchopulmonary dysplasia (BPD) in very preterm infants, with an IND expected in Q3 and plans to enter the clinic in late 2020.
According to Marc Salzberg, MD, President and Chief Executive Officer of Airway, “AT-100 has shown great potential in addressing the inflammation and injury caused by serious respiratory diseases driven by infection but never been produced for larger scale clinical trial indications.” He commented that in association with the urgency of the COVID-19 crisis, the company is committing above and beyond to “develop a manufacturing process for AT-100—leading to a path to clinical development.”
Partner Celonic’s CEO Konstantin Matentzoglu, PhD, commented about the investigational ATMP: “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 the chance to make a difference in the lives of patients at this time of great need.”
Why did the Biotech venture partner with Celonic?
Because Swiss/German Celonic is a leader in biologic manufacturing, they can augment Airway and help them scale their production capacity and hence better position the startup to meet the needs of patients. Celonic, a privately owned CDMO maintains two state-of-the-art sites located at Basel, Switzerland (HQ) and Heidelberg, Germany. The company specializes in providing comprehensive GMP development and manufacturing services for new biological entities (NBEs) and Biosimilars, worldwide, as well as Cell Therapy & Gene associated services worldwide.
What is special about Celonic’s approach to life sciences-based GMP?
Well they tout their human cell line expression system with fully human glycosylation as a superior platform for high-yield GMP production of challenging complex molecules such as bispecific antibodies, fusion proteins, antibody fragment and blood factors.
Moreover, the company is positioned as one of a few global bio-solution providers that can offer perfusion continuous cell culture manufacturing for both CHO and human cell lines—at a large 1,000-liter bioreactor scale.
Have the partners been preparing the outsourcing transfer?
Yes. They have spent an intense several months working together to transfer the AT-100 manufacturing technology to Celonic. The goal: scale up GMP batch production to support a clinical trial in COVID-19 patients.
What is Airway Therapeutics background?
Based in Cincinnati, Airway Therapeutics is a spinoff of Cincinnati Children’s Hospital Medical Center developing a new class of biologics to break the cycle of injury and inflammation for patients with respiratory and inflammatory diseases, starting with the most vulnerable populations. The company is advancing the novel recombinant human protein rhSP-D, an engineered version of 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. The company is led by CEO Marc Salzman.
The company was a spinoff from Cincinnati Children’s Hospital Medical Center. It was created to commercialize the pulmonary therapy research developed there—starting with a $500,000 investment from CincyTech and Cincinnati Children’s Tomorrow Fund. The investments were part of a projected $1.2 million seed stage funding round led by CincyTech. The company got its start at BioStart, the Cincinnati bioscience startup center located in Clifton, a previous investor in Airway.
The Intellectual Property
This intellectual property is based on 10 years of research by Jeffrey Whitsett, MD, at Cincinnati Children’s Hospital Medical Center. Dr. Whitsett is chief of the Section of Neonatology, Perinatal and Pulmonary Biology at Children’s and one of the Children’s most prolific researchers.