Innovent Announces First Patient Dosed in a Pivotal Trial of

|Apr 27|magazine12 min read

SUZHOU, China, April 28, 2020 /PRNewswire/ -- 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, today announced 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. The objective of this study is to evaluate the efficacy and safety of parsaclisib in patients with recurrent or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) in China.

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.

About Innovent 

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with 16 in clinical development, 5 in Phase 3 or pivotal clinical trials, 3 under NDA reviews by the NMPA with priority review status, while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit:www.innoventbio.com.

SOURCE Innovent Biologics, Inc.