InnoCare Announces Approval of Clinical Trial of BCL2 Inhibitor ICP-248 in Combination with Orelabrutinib as First-Line Therapy for Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma in China

Mar. 13, 2024 - InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, announced today the approval of the Investigational New Drug (IND) to conduct the clinical trial of B-cell lymphoma-2 (BCL2) inhibitor ICP-248 in combination with Bruton's tyrosine kinase (BTK) inhibitor orelabrutinib as first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China.

This multicenter, randomized-controlled, open-label clinical study is designed to evaluate the efficacy and safety of ICP-248 combined with orelabrutinib versus immunochemotherapy in treatment-naive patients with CLL/SLL.

ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor, which aims to treat hematologic malignancies as a monotherapy or in combination with other therapies. 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 and restoring the mechanism of programmed cell death. The preliminary result has demonstrated a good efficacy and safety profile.

Orelabrutinib has been approved for marketing in China and Singapore, and all three approved indications related to lymphoma have been included in the National Reimbursement Drug List (NRDL) in China. In the treatment of relapsed/refractor CLL/SLL patients with orelabrutinib, the overall response rate and complete response rate reached 93.8% and 30% respectively, demonstrating an outstanding efficacy and safety profile.

Dr. Jasmine Cui, the co-founder, chairwoman and CEO of InnoCare, said, "InnoCare has developed strong pipeline in hemato-oncology that covers a variety of important hemato-oncology targets, including BTK, BLC2, CD19, CD20xCD3, E-3 ligase, etc. ICP-248 and orelabrutinib are important global assets of our company in the field of hematology, with multiple clinical studies conducted in China and the United States. We will accelerate clinical development and look forward to providing CLL/SLL patients with more efficient and safe treatment options."

CLL/SLL, one of the most common types of leukemia, is an indolent malignancy of B lymphocytes. There are 191,000 newly diagnosed CLL cases and 61,000 deaths every year globally . The incidence rate of CLL/SLL is on the rise in China .