AATec Medical and Northway Biotech Partner to Develop Lung Disease Therapy

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

AATech Medical GmbH, a biotech company developing a platform to treat respiratory diseases, and Northway Biotech, a contract development and manufacturing organization (CDMO), announced on July 15, 2025, that they have entered a partnership for Northway to manage process development and analytical development of AATec’s lead product candidate, ATL-105 (1).

ATL-105 is a proprietary, inhaled therapy based on recombinant alpha-1 antitrypsin (AAT) for non-cystic fibrosis bronchiectasis (NCFB), a chronic inflammatory respiratory condition. NCFB presents with dilated bronchi, persistent inflammation, frequent airway infections, and impaired mucus clearance, according to the press release (1). ATL-105 works by targeting the condition through a broad multimodal mechanism of action. ATL-105 may also be used in the future to treat other inflammatory and infections respiratory diseases, the companies state.

Utilization of a CDMO’s expertise

Northway Biotech will use its expertise in biologics manufacturing to develop and scale the production for ATL-105 by using the Pichia pastoris expression system, one of the most popular and standard tools for the production of recombinant protein in molecular biology. (1). The company specializes in protein-based biologics, gene therapies, cell line development, process optimization, and current good manufacturing practice manufacturing.

“With this partnership, we are establishing a robust and scalable production process for ATL-105, laying the foundation for consistent quality for clinical development and commercial use,” Rüdiger Jankowsky, PhD, co-founder and CEO of AATec, said in the press release (1). “ATL-105 represents a new generation of inhaled biologics, combining anti-protease, anti-inflammatory, and anti-infective properties in one molecule. Delivered directly to the lungs, it enables fast, targeted action with minimal systemic exposure. We believe ATL-105 can redefine care in respiratory diseases with high medical need, such as non-CF bronchiectasis.”

“We are excited to support AATec in progressing towards clinical trials,” added Vladas Algirdas Bumelis, CEO and chairman of Northway Biotech (1). “AATec is advancing a promising therapeutic solution addressing significant unmet medical needs, supported by a highly capable and dedicated team. With our decades of expertise in microbial systems, we are well-positioned to scale this program efficiently and deliver quality at every step.”

André Markmann, PhD, VP of Business Development at Northway Biotech, stated, “We have recognized the opportunity to support a program that could meaningfully advance care for patients with respiratory diseases. Inhaled protein therapies are gaining significant traction, and ATL-105 stands out as one of the most promising approaches in this area.”

Novel biologics delivery

Researchers have been working to find modes of delivery for biologic drugs beyond injection and infusion, which can make patient adherence difficult. Large-molecule drugs, however, have increased structural requirements compared with small-molecule therapies (2), which can make this tricky.

“These limitations often result in poor bioavailability for a variety of reasons, including degradation while in the alimentary tract, inability to overcome intestinal cell or mucosal barriers, and first-pass metabolism, which is avoided with the traditional injection routes,” Frank Tagliaferri, PhD, chief scientific officer at Pace Life Sciences, told BioPharm International® (2). “While there may be beneficial solutions to these hurdles individually, it is a significant challenge to overcome all of them with what will generally be a higher-cost biologic drug where extremely low bioavailability is not always economically feasible.”

Biologic drugs delivered through inhalation is actively being pursued and has led to innovations in antisense oligonucleotides, messenger RNA, and lipid nanoparticles. The COVID-19 pandemic also spurred the drive to improve vaccine delivery.In addition, the growing asthma biologics market is adding to the push for inhaled delivery (2).

References

1. AATec and Northway Biotech. AATec Medical and Northway Biotech Announce Partnership to Develop Industrial Production Process for ATL-105 Targeting Lung Diseases. Press Release. July 15, 2025. https://www.northwaybiotech.com/blog/aatec-medical-and-northway-biotech-announce-partnership-to-develop-industrial-production-process-for-atl-105-targeting-lung-diseases
2. Mirasol, F. Exploring Innovative Means for Biologics Delivery. BioPharm International 2024 37 (8).