Commercialised anticalin inhaled treatments

Pieris Pharmaceuticals and AstraZeneca collaborate to develop and commercialise treatments for respiratory diseases

Pieris Pharmaceuticals has begun a collaboration with AstraZeneca to develop novel inhaled drugs for respiratory diseases.

The collaboration will leverage Pieris' Anticalin platform, including its lead preclinical drug candidate, PRS-060.

Anticalin molecules are engineered proteins which can mimic antibodies by binding to sites either on other proteins or on small molecules. They are smaller than monoclonal antibodies, offering the potential of direct delivery to the lung.

Pieris will be responsible for advancing its preclinical lead candidate, PRS-060, into Phase 1 clinical trials in 2017. PRS-060 is an Anticalin against interleukin-4 receptor alpha (IL-4Ra) with potential in asthma.

In addition, the parties will collaborate to progress four additional novel Anticalins against undisclosed targets for respiratory diseases with Pieris having the option to co-develop and co-commercialise two of these programs in the US.

Stephen Yoder, President and Chief Executive Officer of Pieris, said:

“Our partnership with AstraZeneca accelerates the transformation of Pieris into a fully-integrated drug development and commercial organisation, comprising two main pillars in immunology: respiratory diseases and immuno-oncology.”

“AstraZeneca's expertise in the development of inhaled drugs will maximize the potential of PRS-060 and other inhaled Anticalin molecules.”

Louis Matis, Senior Vice President and Chief Development Officer of Pieris, said:

“Based on the limitations of many types of biologic molecules, direct delivery to the lungs via inhalation has been challenging to date for other classes of therapeutic proteins.”

“Anticalin proteins have unique properties, not least of which is their size and stability, and show considerable promise for this route of delivery.”

PRS-060

PRS-060, an Anticalin protein potently engaging IL-4Rα, is being developed for patients suffering from moderate to severe asthma, many of whom are not able to control their asthma well with currently available medications.

In a large proportion of asthma patients, the Th2 pathway plays an important role. IL-4 and IL-13 are the main cytokines involved in Th2-mediated asthma. Both signal via IL-4Rα, making IL-4Rα a cornerstone intervention point.

PRS-060 differentiates from antibody approaches through inhaled delivery directly into the lungs, potentially resulting in efficacy and safety benefits.

The local delivery may allow for lower doses than systemically administered antibodies, potentially also resulting in a significant cost of goods advantage over those therapies. Pieris has demonstrated proof of concept in animals as well as feasibility for pulmonary delivery with PRS-060.

Finance

AstraZeneca will fund all clinical development and subsequent commercialisation programs and Pieris has the option of co-development and co-commercialisation in the US from Phase 2a onwards.

AstraZeneca will make an upfront and near term milestone payments to Pieris in the amount of $57.5 m; $45m of upfront payments and $12.5m for the initiation of the PRS-060 Phase 1 trial.

Pieris has the potential to receive development-dependent milestones and eventual commercial payments for all products not exceeding $2.1bn as well as tiered royalties on the sales of any potential products commercialised by AstraZeneca.

For programs co-developed by Pieris, the company stands to receive increased royalties or a gross margin share on worldwide sales equal, dependent on the level of investment to which Pieris commits.

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