Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced data from an ongoing pivotal Phase 2 study (CIBI376A201) evaluating parsaclisib, an potent, highly selective, next-generation oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), for the treatment of patients with relapsed or refractory follicular lymphoma in China. These data were presented at the 63rd American Society of Hematology Annual Meeting and Exposition (ASH 2021), held virtually from December 11–14, 2021.

The CIBI376A201 study is a multi-center, single-arm, open-label pivotal Phase 2 study conducted in China evaluating parsaclisib as a treatment for patients with relapsed or refractory follicular lymphoma. The primary endpoint is objective response rate (ORR) as assessed by independent review committee (IRC); duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety and tolerability are among the secondary endpoints as assessed by investigators.

Eligible patients received parsaclisib 20 mg once daily for eight weeks followed by 2.5 mg once daily, till disease progression or intolerable adverse events. By the data cut-off date, 36 patients were enrolled, of which 24 were evaluable.

Key results of this study are: In 24 evaluable patients with r/r FL, ORR is 91.7% (95%CI : 73%, 99%), Complete Response(CR) is 16.7%, and Partial Response (PR) is 75%. As the results showed, parsaclisib was generally well tolerated with a manageable safety profile.

"We are glad that the data from study CIBI376A201 appears promising, which indicates the potential of parsaclisib to become a clinically valuable treatment for patients with relapsed or refractory follicular lymphoma," said Dr. Hui Zhou, Vice President of Innovent, "We hope the results of this study may potentially provide a new treatment option and help benefit those patients in China."

The leading PI of the study, Dr. Weili Zhao of Shanghai Jiaotong University Ruijin Hospital, stated "The interim analysis shows good response and a tolerable safety profile of parsaclisib in FL patients. We look forward to more exciting results to be revealed with the potential for parsaclisib to be a new effective treatment option for doctors to tackle relapsed or refractory follicular lymphoma."

Presentations are available on the ASH website at: https://ash.confex.com/ash/2021/webprogram/Paper150002.html 

About Follicular Lymphoma

Follicular lymphoma 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 may lead to death within 1 to 2 years. There is an unmet medical need for treatment options for recurrent/refractory follicular lymphoma.

About Parsaclisib

Parsaclisib is a potent, highly selective, next-generation investigational novel oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). It is currently under evaluation as a monotherapy in several ongoing Phase 2 trials as a treatment for non-Hodgkin lymphomas (follicular, marginal zone and mantle cell); and autoimmune hemolytic anemia. Pivotal trials of parsaclisib in combination with ruxolitinib for the treatment of patients with myelofibrosis are underway; and there are plans to initiate a trial to evaluate parsaclisib in combination with tafasitamab for B-cell malignancies.

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 parsaclisib and two other assets in Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

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 cancer, metabolic, autoimmune and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong, S.A.R., China 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 26 valuable assets in the fields of cancer, metabolic, autoimmune diseases and other major therapeutic areas, with 6 products, TYVYT? (sintilimab injection), BYVASDA? (bevacizumab biosimilar injection), SULINNO? (adalimumab biosimilar injection), HALPRYZA? (rituximab biosimilar injection),PEMAZYRE? (pemigatinib) and Olverematinib (BCR TKI) officially approved for marketing in China, 5 assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in clinical trials.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Roche, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. For more information, please visit: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

Note:
TYVYT? (sintilimab injection) is not an approved product in the United States.

BYVASDA? (bevacizumab biosimilar injection), SULINNO?, and HALPRYZA? (rituximab biosimilar injection) are not approved products in the United States.

TYVYT? (sintilimab injection, Innovent)
BYVASDA? (bevacizumab biosimilar injection, Innovent)
HALPRYZA? (rituximab biosimilar injection, Innovent)
SULINNO? (adalimumab biosimilar injection, Innovent)
Pemazyre? (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre? was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, S.A.R., China, Macau, S.A.R., China and Taiwan, China.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professionals only.

Forward-Looking Statements

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These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

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Source: Innovent Biologics