The license and collaboration agreement center on orelabrutinib, an oral small molecule BTKi characterized by its high selectivity and the ability to cross the blood-brain barrier.
John Tlumacki/The Boston Globe via Getty Images
Biogen, a global pharmaceutical operations and technology company, has partnered with Chinese commercial-stage biopharmaceutical firm InnoCare Pharma to develop a treatment for multiple sclerosis.
The license and collaboration agreement center on orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) characterized by its high selectivity and the ability to cross the blood-brain barrier. At present, clinical studies on orelabrutinib are in the Phase 2 testing on patients with relapsing-remitting MS.
The molecule has the capacity to inhibit BTKi, which is responsible for the signaling cascade of myeloid, B cells, and other immune cells. Because orelabrutinib can cross the BBB, it may have the ability to inhibit immune cells in the central nervous system (CNS), thereby potentially slowing down, if not thwarting, the progression in all forms of multiple sclerosis.
“Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs... We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS,” Alfred Sandrock, Jr., M.D., Ph.D., head of Biogen’s research and development arm, was quoted as saying.
Biogen’s work globally has consistently centered on the neurosciences and working with InnoCare to create innovative medicines is a significant step forward to finally addressing the many unmet medical needs of many diseases. Under the terms of the deal, Biogen will gain exclusive rights to orelabrutinib in the global field of MS and certain autoimmune conditions outside of China, Taiwan, Macau, and Hong Kong. InnoCare will keep its exclusive worldwide rights to the same in the oncology field and certain autoimmune diseases inside China.
“We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS” said Jasmine Cui, Ph.D., co-founder, chairwoman, and chief executive officer at InnoCare.
Biogen figured prominently in the news sometime in June 2021 after getting the US Food and Drug Administration’s approval to market aducanumab (trade name Aduhelm) in the treatment of Alzheimer’s disease. This is the first drug approved that addresses the condition’s underlying cause.
Although it met plenty of controversy over the past years, the FDA panel eventually ruled that aducanumab may be used as part of therapy, saying “If we wait for the perfect drug or perfect data, we will descend further into the grip of this awful disease... people staring into the abyss of Alzheimer’s deserve no less.”
In the latest deal, Biogen will pay $125 million upfront. It also stands to deliver up to $812.5 million in potential commercial payments and development milestones should the partnership yield commercial milestones and hit sales thresholds. InnoCare may also receive tiered royalties on possible future net sales of any product that results from this collaboration. The deal is considered officially closed pending regulatory approvals.
