AATec is pioneering a new ­approach to lung diseases

European Biotechnology: AATec is developing a new class of therapeutics for respiratory diseases. What makes you so excited about the program?

Rüdiger Jankowsky: What excites us is the idea of creating a new platform for respiratory diseases with a high unmet need. Because our approach is based on a human molecule with broad activity and an established safety profile, it could be relevant not only for our lead indication non-CF bronchiectasis, but also for COPD and other lung diseases, as well as rare diseases of the airways.

Gabriele Matschiner: The key for us is that we combine this broad activity with delivery to the lungs. We can target several disease drivers directly where they occur and limit drug exposure elsewhere in the body.

EB: Why is ATL-105 a promising approach for chronic respiratory diseases, and what sets it apart?

Jankowsky: ATL-105 is based on alpha-1 antitrypsin (AAT), a naturally occurring human protein that helps protect the lung from excessive inflammation and tissue damage. That is key in chronic respiratory diseases, where inflammation, damaging proteases and infection often come together. ATL-105 addresses several disease drivers at once through its combined anti-inflammatory, antiprotease and anti-infective activity.

EB: Why did you choose non-cystic fibrosis bronchiectasis as the first clinical indication?

Matschiner: Bronchiectasis still comes with a high unmet medical need. One of its hallmarks is neutrophilic inflammation, which drives damaging proteases and airway damage. This gives us a very clear way to test the mechanism of ATL-105 in patients. And because the disease mainly affects the larger airways, it is also readily accessible to inhalation treatment.

EB: Which preclinical findings gave you the confidence to move ATL-105 into the clinic?

Matschiner: The key moment was seeing that ATL-105 reduced neutrophilic inflammation in vivo when we delivered it directly to the lungs. In addition, we saw a clear, dose-dependent effect in lung samples from patients, and it was well tolerated even at high local concentrations in our toxicology studies.

EB: What would success look like in the first clinical trial?

Matschiner: We will conduct a randomized, placebo-controlled Phase 1b/2a study directly in patients, testing different doses of ATL-105. Success would mean showing safety and tolerability together with a dose-dependent reduction in protease activity. That would provide clinical proof of concept and help us select the dose for the next stage of development.

EB: Was there a moment when you realized ATL-105 could become more than an interesting scientific concept?

Jankowsky: The in vivo data were an important turning point. But what finally transformed the concept into a product-development program was the full package: the biological activity, the excellent product quality and the fact that we could nebulize ATL-105 while completely maintaining its activity. That confidence is reinforced by strong interest from international clinical experts, investors and global pharmaceutical companies, as well as by the backing in our pre-series A financing round of SPRIN-D, the German federal agency for breakthrough innovation.

About the interviewees:

Rüdiger Jankowsky, CEO and co-founder of AATec, has more than 25 years of leadership experience in biotech, with a focus on product development, regulatory approval and corporate development.

Gabriele Matschiner, CDO, brings more than 20 years of experience in translational and early clinical ­development, particularly in respiratory diseases and ­inhaled biologics.

This article is sponsored by AATec.