Date: 2017-05-03
Type of information: Development agreement
Compound: Anticalin® platform, including PRS-060
Company: AstraZeneca (UK) Pieris Pharmaceuticals (Germany)
Therapeutic area: Allergic diseases – Inflammatory diseases – Respiratory diseases
Type agreement: development - commercialisation
Action mechanism:
- protein. Anticalins® are recombinantly engineered versions of human lipocalins. These engineered proteins 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.
- PRS-060 is an Anticalin against interleukin-4 receptor alpha (IL-4Ra) with potential in asthma. 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-4R?, making IL-4R? 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.
Disease: asthma
Details:
- • On May 3, 2017, Pieris Pharmaceuticals announced a strategic collaboration in respiratory diseases with AstraZeneca to develop novel inhaled drugs that leverage Pieris' Anticalin® platform, including its lead preclinical drug candidate, PRS-060. Under the collaboration, 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. AstraZeneca will fund all clinical development and subsequent commercialization programs and Pieris has the option of co-development and co-commercialization in the US from Phase 2a onwards. 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-commercialize in the US two of these programs.
Financial terms:
- AstraZeneca will make an upfront and near term milestone payments to Pieris in the amount of $57.5 million -- $45 million of upfront payments and $12.5 million 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 $2.1 billion as well as tiered royalties on the sales of any potential products commercialized 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.
Latest news:
- On August 9, 2017, Pieris announced that the company is on track to advance its lead respiratory program, PRS-060, into a first-in-human trial in the second half of this year. The company plans to dose healthy subjects in the fourth quarter of 2017 in a single-ascending dose trial, followed by a multi-ascending dose trial, under a clinical trial notification to the Therapeutic Goods Administration in Australia.
- The dosing of the first subject will trigger a milestone payment of $12.5 million by AstraZeneca to Pieris.
Is general: Yes
