$2.16 billion deal leverages Pieris’ Anticalin platform for the development of inhaled drugs.

AstraZeneca has entered into a strategic collaboration with clinical-stage biotechnology company Pieris Pharmaceuticals to fight respiratory diseases, a key therapeutic area for AstraZeneca. The partnership will utilize Pieris’ Anticalin^® platform to develop novel inhalation drugs, which will expand AstraZeneca’s current portfolio of existing and pipeline products. According to the company, its goal is to “transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.” The collaboration will build on AztraZeneca’s 40-year heritage in respiratory disease and its capability in inhalation technology, including both pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), and its Co-Suspension^TM Delivery Technology.

Pieris’ Anticalin-based drugs are engineered proteins that are smaller than monoclonal antibodies yet have the ability to mimic antibodies and target validated disease pathways by binding to sites on other proteins or small molecules. Its Anticalin^® proteins have been validated in the clinic and by partnerships with leading pharmaceutical companies. In addition to an inhaled Anticalin^® protein to treat uncontrolled asthma and a half-life-optimized Anticalin protein to treat anemia, the company’s pipeline includes immuno-oncology multi-specifics tailored for the tumor micro-environment. AstraZeneca is interested in the Anticalin technology because, according to the accompany, it offers the potential for targeted drug delivery to the lungs.

The deal includes initial and early milestone payments to Pieris totaling $57.5 million. AstraZeneca will make additional payments not to exceed $2.1 billion including those for the achievement of milestones and commercial success. Piers will also receive royalties on any sales of products developed through the collaboration and commercialized by AstraZeneca.

Pieris is responsible for reaching Phase I clinical trials with PRS-060, an Anticalin that targets interleukin-4 receptor alpha (IL-4Ra) and the company’s preclinical lead candidate. PRS-060 is being developed for the treatment of patients with moderate to severe asthma who have not been successful in controlling their symptoms with existing drugs. Unlike other antibody treatments, PRS-060 has the potential to be directly inhaled into the lungs for targeted delivery and the possible use of lower doses. Proof of concept has been demonstrated in animals, including pulmonary delivery.

Funding for clinical development and commercialization activities will come from AstraZeneca, but Pieris can choose to co-develop and co-commercialize the products in the US starting with Phase IIa studies. The two companies have also agreed to four other Anticalins that target unnamed respiratory diseases.

The collaboration agreement is conditional upon the expiration or early termination of the applicable waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.