InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib, as a first-line therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). The multicenter study will compare the ICP-248 plus orelabrutinib regimen against immunochemotherapy in treatment-naïve CLL/SLL patients.
ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor designed to treat hematologic malignancies, either as a monotherapy or in combination with other treatments. The molecule targets BCL2 to selectively inhibit its activity, thereby restoring the programmed cell death mechanism, with preclinical data showing a promising efficacy and safety profile.
InnoCare’s orelabrutinib, developed in-house, is already approved in China for three indications: relapsed/refractory (R/R) CLL/SLL, R/R mantle cell lymphoma (MCL), and R/R marginal zone lymphoma (MZL). The drug has demonstrated strong efficacy in CLL/SLL, with overall response and complete response rates of 93.8% and 30%, respectively.- Flcube.com
