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The companies will develop treatments for a range of neurological and inflammatory diseases.
Sanofi announced plans to collaborate with Denali Therapeutics, a San Francisco, CA-based biopharmaceutical company focused on neurodegenerative diseases, in a deal potentially worth more than $1 billion to develop multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases.
Under the terms of the agreement, Sanofi will make an upfront cash payment to Denali of $125 million, with future development and commercial milestone payments that could exceed $1 billion. Sanofi and Denali will share commercial profits and losses from DNL747-a brain-penetrant small molecule currently being evaluated in early Phase I clinical trials-in the United States and China equally, while Denali will receive a royalty from Sanofi for other territories for DNL747 and worldwide for DNL758, a small molecule that does not penetrate the brain. DNL758 is expected to begin clinical trials in 2019.
The transaction is expected to close in the coming months following the Nov. 1, 2018 announcement, in accordance with customary regulatory approvals.
The two lead molecules, DNL747 and DNL758, target a critical signaling protein known as receptor-interacting serine/threonine-protein kinase 1 (RIPK1) in the tumor necrosis factor receptor pathway, which regulates inflammation and cell death in tissues throughout the body, according to the companies. The companies plan to study DNL747 in multiple sclerosis (MS), Alzheimer’s disease, and amyotrophic lateral sclerosis (ALS), and DNL758 in systemic inflammatory diseases such as rheumatoid arthritis and psoriasis.
Phase Ib and II clinical development costs for DNL747 will be fully funded by Sanofi for MS, ALS, and other neurological indications, except in Alzheimer’s disease, which will be funded by Denali. Phase III trials for all neurological indications will be jointly funded by Sanofi (70%) and Denali (30%). Sanofi will fully fund the clinical development costs for DNL758 in systemic inflammatory diseases.
Sanofi reports that it will lead clinical development activities for all systemic inflammatory diseases. Additionally, the collaboration includes additional pre-clinical RIPK1 inhibitor molecules.
“RIPK1 is a promising target with the potential to bring disease modifying medicines to patients suffering from neurodegenerative diseases as well as systemic inflammatory diseases. We are very excited to partner with Sanofi and expand our RIPK1 program into new indications,” said Ryan Watts, PhD, CEO of Denali Therapeutics, in a company press release. "With its considerable infrastructure and experience in both clinical development and commercial functions, Sanofi is an ideal partner for Denali to maximize the clinical and commercial success of our RIPK1 program.”