AstraZeneca will develop new inhaled respiratory treatments based on Pieris Pharmaceuticals’ Anticalin® platform—including its lead preclinical drug candidate PRS-060—the companies said today, through a collaboration that could generate more than $2 billion-plus for Pieris.

Anticalin molecules are engineered proteins designed to mimic antibodies by binding to sites either on other proteins or on small molecules. Anticalins hold potential for direct delivery to the lung, since they are smaller than monoclonal antibodies.

PRS-060 is a first-in-class inhaled Anticalin interleukin-4 receptor alpha (IL-4Rα) agonist designed to treat moderate to severe asthma.

Through the collaboration, Pieris agreed to advance PRS-060 into Phase I clinical trials in the second half of this year. AstraZeneca agreed to fund all clinical development and subsequent commercialization programs, with Pieris retaining the option of co-development and co-commercialization in the U.S. from Phase IIa on.

The companies also agreed to advance four additional novel Anticalins against undisclosed targets for respiratory diseases. Pieris will be responsible for initial discovery of novel Anticalin proteins, after which AstraZeneca will lead continued development. Pieris has the option to co-develop two of the four Anticalin programs beginning at a predefined preclinical stage, and would also have the option to co-commercialize these programs in the U.S., while AstraZeneca will be responsible for development and commercialization of the other programs worldwide.

“Our alliance with Pieris adds an important new modality to our respiratory portfolio and builds on our scientific expertise in inhaled formulation technologies,” Mene Pangalos, Ph.D., evp, AstraZeneca’s Innovative Medicines and Early Development Biotech Unit and Business Development, said in a statement.

AstraZeneca agreed to pay Pieris $45 million upfront and $12.5 million tied to initiating the PRS-060 Phase I trial, Pieris stated in a regulatory filing. AstraZeneca also agreed to shell out up to $2.1 billion to Pieris in development-dependent milestone payments and eventual commercial payments if all five programs are successfully commercialized, plus tiered royalties on sales of any products commercialized by the pharma giant.

The collaboration agreement is subject to expiration or early termination of the applicable waiting period, and any extension, under the Hart–Scott–Rodino Antitrust Improvements Act of 1976, as amended.

“We recognize AstraZeneca’s unparalleled expertise in the development of inhaled drugs, which will maximize the potential of PRS-060 and other inhaled Anticalin molecules to become valuable assets for both companies,” added Pieris President and CEO Stephen Yoder, J.D.

“Our partnership with AstraZeneca accelerates the transformation of Pieris into a fully integrated drug development and commercial organization, comprising two main pillars in immunology—respiratory disease and immuno-oncology—each of which is now anchored by a major alliance,” Yoder added.

In January, Pieris launched a partnership with Servier to co-develop Pieris’ preclinical dual-checkpoint inhibitor PRS-332 and up to seven other immuno-oncology bispecific drug candidates, in a collaboration that could generate up to €1.7 billion (nearly $2 billion) for Pieris.

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