On April 28, 2020 Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported that the Company achieved first patient dosing in a pivotal Phase 2 registrational trial of parsaclisib (IBI-376), a novel and selective PI3Kδ inhibitor, in China (Press release, Innovent Biologics, APR 28, 2020, View Source [SID1234556690]). The objective of this study is to evaluate the efficacy and safety of parsaclisib in patients with recurrent and refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) in China.
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Professor Weili Zhao from Ruijin Hospital stated: "Although FL and MZL are indolent, when developed to relapse or refractory stage, the effective treatment is limited and new therapies are urgently needed. PI3Kδ inhibitors are a new class of therapies emerging in recent years for indolent lymphoma treatment. The data from early clinical trials of parsaclisib (PI3Kδ inhibitor) suggests that parsaclisib has good efficacy and tolerance in patients with recurrent or refractory FL/MZL, bringing new hope to the patients in need. We look forward to the results of the pivotal Phase 2 trial of parsaclisib in Chinese patients with recurrent or refractory FL/MZL."
Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "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."
About FL/MZL
Follicular lymphoma (FL) is a B-cell cancer that originates from the uncontrolled division of specific types of B-cells known as centrocytes and centroblasts. Although it is classified as indolent lymphoma, and the current immunochemotherapy has achieved good efficacy, it still often relapses following by aggressive diseases, which lead to death within 1 to 2 years. Recurrent/refractory FL is still a clinical problem that has not been solved yet.
Marginal zone lymphoma (MZL) is also a group of indolent B-cell lymphoma. Although BTK inhibitors have been approved in the United States to treat recurrent/refractory MZL, the reported disease free survival after treatment with BTK inhibitors is short, so new treatments need to be developed on the basis of BTK inhibitors.
About Parsaclisib
Parsaclisib (IBI-376) is an investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ) isoforms. PI3Kδ is an important anticancer target implicated in malignant B-cell growth, survival and proliferation which has demonstrated potency and selectivity in preclinical studies and has potential therapeutic utility in the treatment of patients with hematologic malignancies such as lymphoma. The CITADEL (Clinical Investigation of targeted PI3Kδ Inhibition in Lymphomas) clinical trial program is currently evaluating parsaclisib in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell). Incyte is also conducting Phase 1 and Phase 2 trials of parsaclisib as part of combination therapies for patients with myelofibrosis, diffuse large B-cell lymphoma and autoimmune hemolytic anemia.
In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates, including parsaclisib (PI3Kδ inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the parsaclisib and two other assets in Mainland China, Hong Kong, Macau and Taiwan.