Zydus Cadila, an innovative global pharmaceutical company, and Pieris AG, a next generation therapeutic protein R&D company, have entered into an alliance for development and commercialisation of multiple novel Anticalin based protein therapeutics. The collaboration combines Pieris' drug discovery and early development capabilities with Zydus' expertise in biologics development, regulatory affairs and biologics manufacturing.

Under the terms of the agreement, Zydus will take the lead in advancing Anticalin drug candidates through formal pre-clinical development and into clinical development, undertaking drug development in accordance with ICH guidelines. Zydus has been granted exclusive marketing rights in India and several other emerging markets, while Pieris retains exclusive marketing rights in key developed markets.

Anticalin are recombinantly engineered versions of human lipocalins, low-molecular weight polypeptides that naturally bind, store and transport a wide spectrum of molecules.

Pankaj R Patel, chairman and managing director, Zydus group, said, “Collaborating with established biotech companies on differentiated drug candidates is an important component of Zydus' ongoing transformation into an innovation-led global healthcare provider, and we are pleased to add Anticalins to our novel biologics pipeline.”

Stephen Yoder, CEO of Pieris, said, “With Zydus state-of-the-art manufacturing facilities and seasoned drug development team, this collaboration will allow Pieris to unlock value on a global scale in a cost-effective manner, significantly expanding the number of proprietary Anticalin programmes we can advance into clinical trials.”

The most advanced programme in the collaboration is PRS-110, an Anticalin specific for c-Met, a target becoming increasingly validated across a broad spectrum of tumours PRS_110, which is a pure antagonist due to its monovalent target engagement, has demonstrated the ability to inhibit both ligand-dependent and independent c-Met activity in a variety of animal models. Through this unique collaborative model, the companies seek to develop candidates to proof-of-concept and will explore out-licensing opportunities in Pieris' territories at the appropriate time. The companies will share licensing revenues on mutually agreed-upon terms.

Zydus has developed a pipeline of 17 biosimilar drugs with six such drugs commercialised and others in clinical development.