CAMBRIDGE, Mass. & TOKYO—Astellas Pharma Inc. and Proteostasis Therapeutics Inc. have announced the establishment of a worldwide collaboration for the research and development of therapeutic candidates that can modulate the Unfolded Protein Response (UPR) via the use of Proteostasis Therapeutics' proprietary Disease Relevant Translation (DRT) and Proteostasis Network platform. Per the terms of the agreement, Astellas will make an initial upfront payment to Proteostasis Therapeutics, as well as a securities investment. Proteostasis Therapeutics will also be eligible for research funding support, future development and commercial milestones, which could lead to total payments of more than $400 million, and tiered royalties. The collaboration stipulates that Astellas has the right to initiate two additional projects under the same terms, and if fully exercised, the deal could potentially be worth $1.2 billion.
“Proteostasis Therapeutics has a novel platform that offers a differentiated approach to discovering drugs for unmet medical needs,” Kenji Yasukawa, Ph.D., senior vice president and chief strategy officer at Astellas, noted in a statement. “It complements our existing internal and externalized R&D initiatives, and we continue to invest in innovative technologies that can provide new therapeutic options to patients. We look forward to working closely with Proteostasis Therapeutics to identify lead candidates for clinical development and potential commercialization.”
Under the agreement, the two companies will undertake discovery, screening and preclinical research to identify lead compounds suitable for clinical development. When candidates are selected, Proteostasis Therapeutics will have the rights to opt in for global co-development and for co-promotion in the United States. Innovation Management of Astellas is leading the collaboration.
“We are very pleased to be collaborating with Astellas, a worldwide leader in the development of innovative therapeutics,” said Meenu Chhabra, president and CEO at Proteostasis Therapeutics. “Our novel approach to drug discovery, coupled with Astellas’ track record in drug development, will enable rapid discovery and development of therapies for important unmet medical needs.”
The collaboration will be focused on one genetic disease and include exploration of other indications in which modulation of the UPR pathway could be effective. Unfolded proteins accumulating in the endoplasmic reticulum can lead to stress, a process seen in many protein conformational diseases, including genetic, neurodegenerative and retinal degenerative diseases. In non-clinical investigations, selectively modulating this pathway improved stress response while restoring function.
At the same time, Astellas announced another new collaboration that will be led by Innovation Management. Under that agreement, Astellas and the Dana-Farber Cancer Institute struck a three-year collaboration for the research and development of small-molecule inhibitors of oncogenic K-Ras, the most commonly mutated oncogene in human cancers, for the treatment of cancer. Some 30 percent of cancers present activating ras mutations, and those cancers with a high prevalence of K-Ras mutations are difficult to treat, with poor outcomes. The agreement also grants Astellas an option to obtain an exclusive, worldwide license from Dana-Farber to novel K-Ras inhibitors that result from the collaboration, and should that option be exercised, Astellas would conduct further preclinical research and development on those inhibitors, as well as clinical development and commercialization.