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信达生物将在WCLC及ESMO 2024年会上公布IBI363(PD-1/IL-2α-bias)等多项创新管线更新临床数据

Innovent Bio will announce updated clinical data for multiple innovative pipeline products, including IBI363 (PD-1/IL-2α-bias), at the WCLC and ESMO 2024 conferences.

PR Newswire ·  Aug 29 08:00

San Francisco, USA and Suzhou, China, August 29, 2024 / PRNewswire / - Innovent Biologics Group (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research and development, production, and sales of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, cardiovascular, and ophthalmology, announced today that it will present nearly 20 clinical data, including 6 oral presentations, at the 25th World Conference on Lung Cancer (WCLC) and the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. The WCLC conference will be held from September 7 to September 10, 2024, in San Diego, USA, and the ESMO Annual Meeting will be held from September 13 to September 17, 2024 in Barcelona, Spain.

The data covers: 1st phase update data of the global first IBI363 (PD-1 / IL-2α-bias) in the lung cancer treatment group (including data update of the 3mg/kg dose group) in the oral presentation at WCLC, 1st phase update data of the combined treatment group for certain colorectal cancers in the presentation at ESMO, key clinical data of Davotinib (fluazinam, KRAS G12C inhibitor) for the treatment of NSCLC in the oral presentation at WCLC, 1st phase data of IBI354 (HER2 ADC) for the treatment of HER2-positive solid tumors in the oral presentation at ESMO, and multiple clinical data of Darbrus (sintilimab injection).

Dr. Zhou Hui, Senior Vice President of Innovent Biologics Group, said, "We are pleased to continue updating clinical data on multiple next-generation innovative tumor bispecific antibodies and ADC molecules from Innovent Biologics at the two international academic conferences in September, following the ASCO, ESMO Plenary, and ESMO GI conferences in June this year. The achievements made in the early exploration are gratifying and give us confidence in further development. As a biopharmaceutical company with a few IO+ADC technology platforms and abundant pipeline reserves, Innovent Biologics will continue to make breakthroughs in cancer treatment and strive to provide more innovative, effective, and safe treatment methods and solutions for doctors and patients."

Summary information of important clinical research results is as follows:

WCLC Oral Presentation

Summary Title: Clinical Phase I Study of the First-in-Class PD-1/IL-2 Bispecific Antibody Fusion Protein IBI363 in Advanced Non-Small Cell Lung Cancer
Summary Number: MA11.04
Conference Type and Format: WCLC 2024 Oral Presentation
Presentation Time: September 10, 2024, 13:37-13:42 Pacific Daylight Time
Speaker: Professor Zhou Jianya, First Affiliated Hospital of Zhejiang University School of Medicine

Summary title: Update on the key phase II clinical study of IBI351, a KRAS G12C inhibitor, in patients with advanced non-small cell lung cancer
Abstract number: OA14.05
Conference type and presentation format: Oral presentation at WCLC 2024
Presentation time: September 9, 2024, 15:52-16:02 Pacific Daylight Time
Speaker: Professor Zhou Qing, People's Hospital of Guangdong Province

Summary title: CTONG2104 study: Phase II study of sintilimab combined with neoadjuvant therapy and optional adjuvant therapy with osimertinib or observation in EGFR-mutant NSCLC
Abstract number: MA15.11
Meeting type and presentation format: Oral presentation.
Presentation time: September 10, 2024, 3:48-3:53 PM.
Speaker: Zhang Chao, Guangdong Lung Cancer Research Institute.

Abstract title: First-line treatment of locally advanced or metastatic pulmonary lymphoepithelioma-like carcinoma: A multicenter, single-arm, Phase II study.
Abstract number: MA11.03.
Meeting type and presentation format: Oral presentation.
Presentation time: September 10, 2024, 1:32-1:37 PM.
Speaker: Zhou Chengzhi, Guangzhou Medical University Affiliated First Hospital

ESMO oral presentation

Abstract title: Clinical Phase I study of IBI354 (anti-HER-2 ADC) in advanced solid tumors and breast cancer patients
Abstract number: 345MO
Conference type and format: ESMO 2024 oral presentation
Presentation time: September 15, 2024, 9:15-9:20 Central European Summer Time
Speaker: Christina Teng, Scientia Clinical Research, Australia

Abstract Title: Clinical Phase I Study of IBI354 (anti-HER-2 ADC) in Advanced Gynecological Cancer Patients
Abstract Number: 720MO
Conference Type and Presentation Format: ESMO 2024 Oral Presentation
Presentation Time: September 15, 2024, 15:45-15:50 Central European Summer Time
Speaker: Shu Jin, Chongqing University Affiliated Tumor Hospital

WCLC Poster Presentation

Abstract Title: Neoadjuvant Chemotherapy and Immunotherapy for Potentially Resectable Stage IIIA/IIIB NSCLC: Updated Survival Results and Efficacy Prediction of MRD
Abstract Number: EP.08D.01
Meeting Type and Presentation Format: Poster
Presentation Time: September 7, 2024, 11:58-11:59 AM
Speaker: Mark Wei, First Hospital of Jilin University

Summary Title: The Safety and Efficacy of Sintilimab Combined with Anlotinib in Patients with Advanced KRAS-Mutant Non-Small Cell Lung Cancer
Abstract Number: P4.11E.10
Meeting Type and Presentation Format: Poster Presentation
Presentation Time: September 9, 2024, Monday 6:30 PM (PDT/ UTC -7)
Speaker: Wang Fen, Peking University Shenzhen Hospital

ESMO Poster Presentation

Abstract Title: Phase I Clinical Study of PD-1/IL-2 Bispecific Antibody Fusion Protein IBI363 Combined with Bevacizumab in Advanced Colorectal Cancer Patients
Abstract Number: 574P
Conference Type and Presentation Format: ESMO 2024 Poster
Presentation Time: September 16, 2024 Central European Summer Time
Speaker: Zhenyu Lin, Huazhong University of Science and Technology Tongji Medical College Affiliated Hiap Hoe Hospital

Abstract Title: Phase I Clinical Study of IBI354 (Anti-HER-2 ADC) in Advanced Gastrointestinal Cancer Patients
Abstract Number: 576P
Meeting Type and Presentation Format: ESMO 2024 Poster
Presentation Time: September 16, 2024, Central European Summer Time
Speaker: Gong Jifang, Peking University Cancer Hospital

Abstract Title: Retrospective Study of HAIC Combined with Sintilimab and Bevacizumab (IBI305) for the Treatment of Inoperable Hepatocellular Carcinoma (HCC) with Child-Pugh B Liver Function Score
Abstract Number: 980P
Meeting Type and Presentation Format: Hepatocellular Carcinoma - Poster
Presentation Time: September 16, 2024, Monday
Speaker: Li Huikai, Tianjin Cancer Hospital Airport Hospital

Abstract title: HAIC combined with Innovent monoclonal antibody and Regorafenib as adjuvant therapy for high-risk recurrent colorectal cancer liver metastases: A single-arm, phase II study
Abstract number: 539P
Conference type and presentation format: Colorectal cancer - Poster
Presentation date: September 16, 2024, Monday
Speaker: Wang Lu, Fudan University Cancer Hospital

Abstract Title: The updated results of the first-line treatment of non-squamous non-small cell lung cancer with gefitinib combined with cianodrilib and chemotherapy in EGFR/ALK negative patients.
Abstract Number: 1329P
Meeting Type and Presentation Format: Metastatic Non-Small Cell Lung Cancer - Poster
Presentation Date: September 14, 2024
Speaker: Ma Pei, Jiangsu Provincial People's Hospital

Abstract Title: Single-center, single-arm, phase II trial of cianodrilib combined with anlotinib in the treatment of advanced sarcoma (SINANLOSARC)
Abstract Number: 1735P
Meeting type and presentation format: Sarcoma - Poster
Presentation time: Saturday, September 14, 2024
Speaker: Liu Zengjun, Affiliated Tumor Hospital of Shandong First Medical University

Abstract Title: Preliminary Results of the Efficacy and Safety of Sugralimab Combined with Anlotinib and Beat-paced Chemotherapy in the Treatment of Advanced Triple-negative Breast Cancer (SPACE): A Single-arm, Multicenter Phase II Trial
Abstract Number: 389P
Meeting type and presentation format: Metastatic Breast Cancer - Poster
Presentation time: Monday, September 16, 2024
Speaker: Li Huihui, Shandong Cancer Hospital

Proposal Presentation (TiP)

Abstract Title: The FIRST-LINE USE OF fruquintinib COMBINED WITH sintiuximab AND CAPEOX IN THE TREATMENT OF ADVANCED GASTRIC CANCER OR GASTRIC-ESOPHAGEAL JUNCTION CANCER: A PHASE 1b/2 CLINICAL TRIAL (FUNCTION)
Abstract number: 1475TiP
Conference Type and Presentation Format: Gastric Esophageal Cancer - Poster
Presentation Time: September 16, 2024, Monday
Speaker: Chen Beibei, Henan Cancer Hospital

"Starting with trust and ending with action", developing high-quality biopharmaceuticals that the general public can afford is the ideal and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to the development, production, and sales of innovative drugs to treat major diseases such as tumors, metabolic diseases, and autoimmune diseases. On October 31, 2018, Innovent Biologics went public on the Main Board of the Hong Kong Stock Exchange with stock code: 01801. Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model. It has established a product chain including 23 new drug varieties, covering multiple disease areas such as tumors, metabolic diseases, and autoimmune diseases, of which 6 varieties have been selected for the national "Major New Drug Creation" special project, and 3 products (Sintilimab Injection, brand name: Tyvyt, English trademark: TYVYT; Bevacizumab Injection, brand name: Duligotong, English trademark: BYVASDA; Camrelizumab Injection, brand name: Sulinno, English trademark: SULINNO) have been approved.

"Start with trust and reach accomplishment", develop affordable high-quality biopharmaceuticals for the lbx pharmacy chain joint stock, that is the mission and goal of innovent bio. Established in 2011, innovent bio is committed to the research and development, production, and sales of innovative drugs in major disease areas such as cancer, autoimmunity, metabolism, and ophthalmology, benefiting more lives with our work. The company has obtained approval for 11 products to be listed, namely Sintilimab Injection (Tyvyt), Bevacizumab Injection (Byvasda), Adalimumab Injection (Ralimab), Rituximab Injection (Tyvyt), Pemigatinib Tablets (Pemazyre), Alectinib Tablets (Alecensa), Lenvatinib Injection (Raltensa), Selpercatinib Capsules (Ryvant), Epyrazole Injection (Fukelsu), Torizumab Injection (Shinbrela), and Fluzoparesib Tablets (Daberte). Currently, there are 3 varieties under NMPA review, 4 new drug molecules in Phase III or pivotal clinical studies, and an additional 18 new drug varieties in clinical trials.

The company has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. While seeking self-development through independent research and development of innovative drugs, Innovent adheres to the development concept of economic construction centering on the people. Over the years, it has always had a scientific and kind heart, stuck to the principle of "patient-centered," concerned about the patients and their families, and actively fulfilled its social responsibilities. The company has launched and participated in a number of drug public welfare assistance projects, enabling more and more patients to benefit from the progress of life sciences and buy and afford high-quality biological drugs. Up to now, Innovent's patient assistance project has benefited more than 170,000 ordinary patients, and the total value of drug donations is 3.4 billion yuan. Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry, to meet the accessibility of the people's medication and the pursuit of a better life and health.

For more details, please visit the company's website: [insert website link] or the company's LinkedIn account.

Declaration:

Innovent Bio does not recommend the use of unapproved drugs/indications.

Leimoceumab injection (Xiranze) and Sipuleucel-T capsules (Ruite) were developed by Eli Lilly and Co.

Forward-looking statements

This press release may contain certain forward-looking statements. These statements inherently involve risks and uncertainties. When using words such as "expect," "believe," "anticipate," "intend," "plan," and other similar expressions, it is the company's intention to identify forward-looking statements. The company has no obligation to continually update these forward-looking statements.

These forward-looking statements are based on management's current views, assumptions, expectations, estimates, forecasts, and understandings of future events, which are inherently subject to risks, uncertainties, and other factors, some of which are beyond the company's control, and may be difficult to predict. Therefore, actual results may differ materially from those included in the forward-looking statements due to future changes and developments in our business, competitive environment, politics, economy, laws, and social circumstances.

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