Date: 2016-10-26
Type of information: Milestone
Compound: Anticalin scaffold technology to discover novel Anticalins against two Daiichi Sankyo targets
Company: Pieris (Germany) Daiichi Sankyo (Japan)
Therapeutic area:
Type agreement: collaboration
licensing
Action mechanism:
- Pieris’ proprietary Anticalin technology platform creates next generation targeted therapeutics and addresses targets in ways that traditional technologies such as monoclonal antibodies cannot. Anticalins are recombinantly engineered lipocalins, endogenous low-molecular weight human proteins that naturally bind, store and transport a wide spectrum of molecules. To obtain a specific Anticalin, Pieris applies its deep protein engineering know-how to select drug candidates from its suite of rationally designed proprietary Anticalin libraries.
Disease:
Details:
- • On April 12, 2011, Pieris has announced the signature of a collaboration and license agreement with Daiichi Sankyo, under which Pieris will apply its proprietary Anticalin scaffold technology to discover novel Anticalins against two Daiichi Sankyo targets. Upon discovery and achievement by Pieris of early preclinical development milestones for lead Anticalin drug candidates, Daiichi Sankyo will assume responsibility for further development and marketing of the Anticalin compounds.
Financial terms:
- Under the terms of the agreement, Pieris will receive more than € 7 million upon signing of the collaboration agreement for the two targets. In addition, Pieris will receive committed research funding and payments for the achievement of research, preclinical, regulatory and commercial milestones. The partnership could encompass for Pieris more than € 100 million per target in license fees, funding and milestones provided the nominated Anticalin achieves full commercialization, and tiered, mid- to mid-high single digit royalties on sales from marketed Anticalins resulting from the collaboration. Daiichi Sankyo will have exclusive marketing rights worldwide for all such products.
Latest news:
- • On October 26, 2016,Pieris Pharmaceuticals announced the achievement of a success-based milestone payment in its R&D collaboration with Daiichi Sankyo. This milestone was triggered by Daiichi Sankyo's decision to initiate a GLP toxicity study in non-human primates. In 2014, Pieris transferred the program to Daiichi Sankyo, who is responsible for further development of the program. Beyond this program, Daiichi Sankyo is currently pursuing an additional Anticalin-based program (DS-9001, anti-PCSK9) for dyslipidemia, which is in the clinical stage of development.
- • On July 8, 2015, Pieris Pharmaceuticals announced it will receive its third milestone payment for the second program in its discovery and development collaboration with Daiichi Sankyo Company, and seventh milestone payment overall under the multi program collaboration. The amount of payment was not disclosed. The payment was triggered by the achievement of positive in vivo proof of concept data and progression of the Anticalin drug candidate through a non-GLP toxicity study in non-human primates.
- • On December 8, 2014, Pieris has achieved the fourth milestone payment for its lead Anticalin® program with Daiichi Sankyo, triggering an undisclosed payment. This milestone marks in total the sixth milestone achieved for the parties' two R&D collaborative projects. Specifically, the milestone was the decision by Daiichi Sankyo to initiate a GLP toxicity study in non-human primates. In 2013, Pieris transferred the program to Daiichi Sankyo, which is responsible for further development of the program.
- • On June 23, 2014, Pieris AG announced that it has achieved a second milestone for its second program, and fifth milestone overall, in its discovery and development collaboration with Daiichi Sankyo, triggering an undisclosed payment. The milestone is based on successful in vitro and in vivo studies validating a range of Anticalin® targeted protein drug candidates designed to bind a Daiichi Sankyo target. With this achievement, Pieris will transfer development responsibility of the program to Daiichi Sankyo, who will initiate further in vivo studies in non-human primates. Under the terms of the 2011 agreement, Pieris receives committed research funding and payments for the achievement of research, preclinical, regulatory and commercial milestones. The partnership could encompass for Pieris more than € 100 million per program in license fees, funding and milestones, not including royalties on sales from marketed Anticalin proteins resulting from the collaboration. Daiichi Sankyo will have exclusive marketing rights worldwide for all such products.
- • On January 13, 2014, Pieris has achieved the third milestone for its lead Anticalin program with Daiichi Sankyo, triggering an undisclosed payment. This milestone marks in total the fourth milestone achieved for the parties' two R&D collaborative projects. Specifically, the milestone achieved was the progression of an Anticalin drug candidate through a non-GLP toxicity study in non-human primates. In 2013, Pieris transferred the program to Daiichi Sankyo, which successfully carried out this study.
- • On November 12, 2013, Pieris has achieved its third milestone overall in its discovery and development collaboration with Daiichi Sankyo, triggering an undisclosed payment. The milestone, which is the first for the companies’ second collaborative program, was triggered by the delivery of several functional picomolar affinity Anticalins® specific for an undisclosed Daiichi Sankyo target.
- • On April 18, 2013, Pieris AG has achieved the second milestone for the first of two programs in its discovery and development collaboration with Daiichi Sankyo, triggering an undisclosed payment. The milestone is based on successful in vitro and in vivo studies validating a range of Anticalin® targeted protein drug candidates designed to bind a Daiichi Sankyo target. With this achievement, Pieris will hand over further development responsibility of the program to Daiichi Sankyo. The company has also announced that it remains on track for the generation of drug candidates for the second Daiichi Sankyo program.
• On October 9, 2012, Pieris has announced the achievement of the first financial milestone in its discovery and development collaboration with Daiichi Sankyo. The milestone recognizes the on-schedule selection, optimization and characterization of several Anticalin® drug candidates, developed using Pieris’ proprietary next-generation scaffold technology, against a Daiichi Sankyo target. The financial details of the milestone payment have not been disclosed. As defined by the agreement, announced in April 2011, this achievement represents the first of two milestones prior to Daiichi Sankyo assuming responsibility for the further development and marketing of the Anticalin program. The next milestone for the first project and the subsequent transfer to Daiichi Sankyo is anticipated for the first quarter of 2013.
Is general: Yes
