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news.InnoCare’s B-cell lymphoma-2 (BCL2) inhibitor, Mesutoclax (ICP-248), has secured breakthrough therapy designation (BTD) from the China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE).
Clinical studies for Mesutoclax are underway both in China and internationally. Credit: National Cancer Institute on Unsplash.
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This designation is intended for the treatment of BTKi-treated relapsed or refractory mantle cell lymphoma (R/R MCL).
Mesutoclax becomes the inaugural BCL2 inhibitor to receive BTD recognition in the country.
The medication is formulated as an orally bioavailable inhibitor, which can be administered as a standalone treatment or in conjunction with orelabrutinib.
Mesutoclax is being developed for treating chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), and other non-Hodgkin’s lymphomas (NHLs), along with acute myeloid leukaemia (AML).
The BCL2 protein is essential in the apoptosis pathway, and its abnormal expression is associated with various blood cancers. The therapy functions by selectively inhibiting BCL2, thus reinstating the normal apoptosis process in cancerous cells.
Clinical studies for Mesutoclax are underway both in China and internationally, including a Phase III registrational trial along with orelabrutinib for CLL/SLL patients.
The BTD designation is intended to accelerate the clinical development of new medications that exhibit significant clinical benefits.
Generally, drugs that receive BTD are aimed at life-threatening conditions or those that greatly diminish quality of life, showing clear advantages in safety or efficacy during clinical evaluations.
InnoCare co-founder, chairwoman and CEO Dr Jasmine Cui said: “We are delighted that mesutoclax has been granted breakthrough therapy designation, which will help expedite multi-centre, multi-indication clinical trials for mesutoclax in China and globally to benefit patients as early as possible.”