Biogen has announced a new collaboration agreement with Chinese biotech company InnoCare for the development a Bruton’s tyrosine kinase (BTK) inhibitor for the potential treatment of multiple sclerosis (MS).
The key focus of the collaboration – orelabrutinib – is currently being evaluated in a multi-country, placebo-controlled phase 2 trial in relapsing-remitting MS.
The drug candidate is designed to inhibit BTK, a key enzyme within the signalling cascade of immune cells including B cells and myeloid cells.
According to Biogen, orelabrutinib has the ability to cross the blood brain barrier, meaning it has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS).
“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,” said Alfred Sandrock, Jr., head of research and development at Biogen.
As part of the agreement, Biogen will gain exclusive rights to the orelabrutinib for MS and certain undisclosed autoimmune diseases globally outside China (including Hong Kong, Macau and Taiwan).
InnoCare will retain exclusive worldwide rights to the BTK inhibitor for oncology and other certain undisclosed autoimmune diseases in China.
In return, the Chinese biotech company will receive a $125m upfront payment and is eligible to receive up to $812.5m in potential development milestone and commercial payments dependent upon the achievement of certain milestones.
Orelabrutinib will fit neatly into Biogen’s MS portfolio, which includes Tecfidera (dimethyl fumarate), Tysabri (natalizumab) and Vumerity (diroximel fumarate).
However, the company is facing patent losses on these key MS drugs, putting more pressure on the potential of orelabrutinib to show benefit in later-stage clinical trials.
“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,” said Jasmine Cui, co-founder, chairwoman and chief executive officer of InnoCare.
“BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS,” she added.