InnoCare Announces Phase III Study Approval of ICP-248 and Orelabrutinib for CLL/SLL in China
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focused on developing therapies for cancer and autoimmune diseases, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has approved the Phase III clinical trial of its B-cell lymphoma-2 (BCL2) inhibitor ICP-248 (Mesutoclax) in combination with orelabrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, for the first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients in China. This approval paves the way for the potential development of a highly promising combination therapy for CLL/SLL, two of the most common forms of leukemia.
ICP-248, also known as Mesutoclax, is a novel oral BCL2 selective inhibitor. BCL2 plays a key role in regulating apoptosis, the process by which cells are programmed to die. Abnormal expression of BCL2 is often linked to the development of various hematologic cancers. By selectively targeting BCL2, ICP-248 helps restore normal apoptosis, thereby inhibiting the growth of cancer cells. In combination with orelabrutinib, this dual approach aims to provide deeper remission and potential clinical cures for treatment-naïve CLL/SLL patients. This combination therapy addresses a significant unmet need by offering an option for patients who have not yet developed drug-resistant mutations.
InnoCare’s Phase II clinical trials of ICP-248, when combined with orelabrutinib, demonstrated promising efficacy and a favorable safety profile in treatment-naïve CLL/SLL patients. These results highlight the combination therapy’s potential to improve the treatment outcomes of CLL/SLL patients, especially those who have not yet been exposed to other therapies. If approved, the combination therapy would provide a powerful treatment option with the potential to offer deeper, more sustained remissions for patients, which is especially important given the chronic nature of these diseases.
Dr. Jasmine Cui, the co-founder, chairwoman, and CEO of InnoCare, expressed the company’s excitement about the approval and the promising future of ICP-248. She said, “ICP-248 is an important global asset in our hemato-oncology portfolio. We are rapidly advancing multiple clinical trials of ICP-248 globally, including the treatment of non-Hodgkin’s lymphoma and acute myeloid leukemia (AML). Our hemato-oncology pipeline is designed for strong synergy, especially with the combination of BTK and BCL2 inhibitors, which has the potential to deliver improved outcomes for patients.”
Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are both indolent malignancies that primarily affect B lymphocytes. CLL is one of the most common types of leukemia, and it has a significant global impact, with 191,000 new cases diagnosed each year and 61,000 related deaths. In China, the incidence of CLL/SLL has been steadily rising, further emphasizing the need for new treatment options. The current treatment landscape includes several chemotherapy and targeted therapy options, but patients often face challenges such as resistance to therapies and the need for more effective, well-tolerated treatments.
Orelabrutinib, the BTK inhibitor in the combination therapy, has already been approved in China and Singapore. It has demonstrated significant efficacy in treating relapsed/refractory CLL/SLL, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL). It is also included in China’s National Reimbursement Drug List (NRDL) for these indications, making it an important treatment option for patients in China.
This partnership between ICP-248 and orelabrutinib leverages the complementary mechanisms of action of these two drugs. BTK inhibitors, like orelabrutinib, play a key role in inhibiting B-cell receptor signaling, which is crucial for the survival and proliferation of B-cell malignancies. Combining a BTK inhibitor with a BCL2 inhibitor provides a multi-pronged approach to attacking CLL/SLL, potentially offering more durable responses and better long-term outcomes for patients.
InnoCare’s commitment to advancing innovative therapies for blood cancers continues to be a cornerstone of its pipeline. The approval of the Phase III trial for ICP-248 in combination with orelabrutinib brings the company closer to offering a new, powerful treatment option for patients with CLL/SLL. It also underscores InnoCare’s broader focus on advancing its hemato-oncology portfolio, which includes multiple clinical trials targeting a variety of hematologic malignancies.
About InnoCare
InnoCare is a biopharmaceutical company with a strong focus on the discovery, development, and commercialization of first-in-class and best-in-class therapies for the treatment of cancer and autoimmune diseases. The company is committed to addressing unmet medical needs in China and around the world. InnoCare operates in major healthcare markets, including Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong, and the United States. The company’s innovative therapies have the potential to significantly impact the treatment landscape of various cancers and autoimmune diseases, improving the lives of patients globally.
