Beijing InnoCare Pharma Tech Co., (HKG: 9969), a China-based biotech focusing on cancer and autoimmune diseases, has announced receiving a notification from US major Biogen (NASDAQ: BIIB) to terminate the licensing agreement for its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. InnoCare regains all rights, including intellectual property, R&D, manufacturing, and commercialization rights to the drug globally.
Background of the Licensing Agreement
Biogen initially struck a licensing deal with InnoCare in July 2021, taking exclusive global rights to the drug for the indication of multiple sclerosis, and unspecified rights to certain autoimmune diseases in markets outside of Greater China (including Hong Kong, Macau, and Taiwan). The deal involved a USD 125 million upfront payment and up to USD 812.5 million in future milestone payouts.
FDA Partial Clinical Hold
In December last year, InnoCare announced that the US FDA had placed orelabrutinib’s MS development on partial clinical hold. As a result, new enrollment in the US Phase II study was halted. Participants in the US who had been on orelabrutinib for less than or equal to 70 days discontinued treatment, while study participants who had completed more than 70 days were allowed to continue receiving the drug.
FDA Action and Company Response
The FDA action was based on a limited number of drug-induced liver injury cases observed with orelabrutinib in the ongoing MS Phase II study and other studies in non-MS autoimmune diseases. For all cases, the elevated laboratory values used for monitoring liver injury were reversible following the suspension of orelabrutinib administration. The company pledged to work closely with the FDA to resolve the issues, including the implementation of enhanced safety measures.
Ongoing Phase II Study and Future Prospects
The Phase II study in MS is still underway and is expected to yield interim results during Q2 this year. Encouraging results from clinical studies for orelabrutinib in multiple autoimmune diseases mean that InnoCare remains positive about the drug’s prospects and is advancing the global clinical development of the drug as a potential best-in-class BTK inhibitor in MS and other autoimmune diseases.
Orelabrutinib’s Regulatory Milestones
Orelabrutinib, the third BTK inhibitor to gain approval in China, already has two conditional approvals from China’s National Medical Products Administration (NMPA), in r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and r/r mantle cell lymphoma (MCL). The drug was awarded a breakthrough therapy designation (BTD) status for use in R/R MCL in the US and is also undergoing a global Phase II study in multiple sclerosis (MS).-Fineline Info & Tech
