Innovent Biologics has dosed the first patient in a phase 2 trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor in follicular lymphoma (FL).
The goal of the study being held in China is to assess the efficacy and safety of parsaclisib in patients having recurrent or refractory follicular lymphoma or marginal zone lymphoma (MZL).
Known to be a B-cell cancer, follicular lymphoma begins from the uncontrolled division of specific types of B-cells called centrocytes and centroblasts. Although classified as indolent lymphoma, and the presently available immunochemotherapy has achieved good efficacy, the condition still often relapses following by aggressive diseases, which results in death within one to two years. Recurrent/refractory follicular lymphoma continues to be a clinical problem that is yet to be solved.
Also a group of indolent B-cell lymphoma, marginal zone lymphoma (MZL) is treated with BTK inhibitors in the US for its recurrent/refractory form. However, the reported disease free survival after treatment with BTK inhibitors is not long enough as a result new treatments have to be developed on the basis of BTK inhibitors.
Dr. Hui Zhou – Vice President and Head of Oncology Strategy and Medical Sciences of Innovent Biologics said: “We are glad that the first patient dosing in the pivotal Phase 2 clinical trial of parsaclisib has been completed, and, if successful, that the data of the study could be used to support the new drug application (NDA) for parsaclisib in China.
“We believe that if parsaclisib achieves approval to enter the Chinese market, it would be a significant milestone, and we hope that the results of this study will help benefit patients with recurrent or refractory FL/MZL and potentially provide more treatment options to the clinicians that treat them.”
Parsaclisib is an oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) isoforms. PI3Kδ is considered to be a major anticancer target that is implicated in malignant B-cell growth, survival, and proliferation which has shown potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients having hematologic malignancies like lymphoma.
In December 2018, Innovent Biologics entered into a collaboration with Incyte for three clinical-stage product candidates that include parsaclisib. As per the terms of the agreement, Innovent Biologics has been given the rights to develop and commercialize the PI3Kδ inhibitor and two other assets in Mainland China, Hong Kong, Macau, and Taiwan.