InnoCare Announces First Patient Dosed in Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for CLL/SLL in China

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor. BCL2 is an important regulatory protein of apoptosis pathway, and its abnormal expression is related to the development of various hematologic malignancies. ICP-248 has an anti-tumor effect by selectively inhibiting BCL2, thereby restoring the process of programmed cell death. ICP-248 demonstrated good safety and efficacy in a phase I study. At a dose of 100 mg QD, all patients achieved an objective response, with a complete response rate (CR) of 50%.

ICP-248 will be developed as a mono-therapy or in combination with other therapies in the treatment of hematological malignancies. It has demonstrated significant synergy with orelabrutinib, enhancing its therapeutic potential.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications have been included in the National Reimbursement Drug List (NRDL) in China, including relapsed/refractory (r/r) CLL/SLL, r/r mantle cell lymphoma (MCL) and r/r marginal zone lymphoma (MZL).

Dr. Jasmine Cui, the Co-founder, Chairwoman and CEO of InnoCare said, "With BTK inhibitor orelabrutinib serving as the backbone therapy, and combined with innovative drugs targeting critical mechanisms such as BCL2, CD19, CD20XCD3 and CRBN E3 Ligase modulator, InnoCare has developed rich pipeline with significant synergy in hemato-oncology. The combination of BTK and BCL2 is expected to bring greater benefits to blood tumor patients."

CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. Globally, there are approximately 191,000 new cases of CLL with 61,000 deaths every year globally[1]. The incidence rate of CLL/SLL is on the rise in China[2].

[1] American Journal of Hematology

[2] Ybanlv