Q-1802

SHANGHAI, May 31, 2022 /PRNewswire/ -- QureBio Ltd., a clinical-stage biopharmaceutical company focusing on bi-specific antibodies and other engineered bio-therapeutics for the treatment of cancer, inflammation, and other serious disorders, today announced that its Q-1802 clinical program was selected for presentation at American Society of Clinical Oncology (ASCO) Annual Meetings on June 3–7, 2022, and the abstract of relevant results for this study has been published on ASCO website ( ). The presentation will showcase the preliminary results of a first-in-human Phase 1a/1b, multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity Q-1802, a Claudin18.2/PD-L1 bi-specific therapeutic in patients with relapsed or refractory solid tumors after standard therapies. Professor Lin Shen from Peking University Cancer Hospital and Institute leads this study. The key data from the mono-therapy of Q-1802 in both dose-escalation and dose-expansion studies demonstrate excellent safety, tolerability, and preliminary anti-tumor activities of Q-1802 at the dose up to 10 mpk. The abstract for the study is found in 2022-ASCO-Annual –Meeting Abstracts (#2568), and the poster session information is listed below. First Author, Dr. Jifang Gong from the Department of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute will present the relevant results on Sunday, June 5, 2022. Session Title: Developmental Therapeutics—Immunotherapy Session Type: Poster Session Date: Sunday, June 5, 2022 Time: 8:00 AM - 11:00 AM, Chicago Time (CDT) Location: Hall A Abstract ID (Temp. ID): 2568 (368426) Poster Board #: 223 Role Responsibilities: Presenter Primary Track: Developmental Therapeutics—Immunotherapy Session begins on Jun 5, 2022 at 8:00 AM Chicago Time (CDT) Room: Hall A-14355 Persons: Dr. Jifang Gong Presenting from 8:00 AM - 11:00 AM, Chicago Time (CDT) About Q-1802 Q-1802, a humanized bi-specific antibody, is the first FDA-approved Claudin18.2/PD-L1 bi-specific therapeutic to enter clinical trial. In animal model studies, Q-1802 demonstrates both superior anti-tumor activities and excellent safety pro It recruits multiple immune mechanisms to kill tumor cells, offering a novel therapeutic opportunity for Claudin18.2 positive solid tumors. Q-1802 also exhibits robust physicochemical properties and superb productivity with titers exceeding 4 grams per liter. About QureBio Ltd. QureBio Ltd. is a clinical-stage biopharmaceutical company focusing on innovative biopharmaceuticals for urgent and unmet clinical needs, such as the treatment of refractory cancers, inflammation and other serious disorders. Founded by experienced scientists from the relevant fields, QureBio Ltd. has built up a series of proprietary technologies for engineered bio-macromolecules, including innovative platforms for bi-specific and tri-specific antibodies. Founded in 2017 with seed capital from Viva Bio-Innovator, QureBio Ltd. has since received a series of funds from Jundu Investment, Watson Capital, Shenzhen Capital Group, New value Capital, Bocom Industrial Investment (Hangzhou) Equity Investment Partnership, Suzhou Oriza Holdings, Hangzhou CAPITAL GuoShun, Zhuhai Longmen Capital Management, Shanghai Pudong Kechuang Group, Shenzhen Lihe Hongxin Venture and Three Rivers Capital. QureBio Ltd. has secured a Series-B funding of nearly 200 million CNY. QureBio Ltd. engages in collaboration with partners to develop novel therapeutics for unmet medical needs and has on-going cooperation with a series of industrial partners including BRL Medicine, BioMap, Precision Scientific, and Hengrui Pharmaceuticals, an industry leader in China.

SUZHOU, China, March 2, 2021 /PRNewswire/ -- Recently, CMAB Biopharma (Suzhou) Inc's ("CMAB") partner QureBio Ltd ("QureBio") has announced its innovative drug Q-1802 received United States Food and Drug Administration (FDA) clearance for an Investigational New Drug (IND) application. This application is the first clinical research in the U.S. by QureBio. Q-1802 is the lead candidate in QureBio's pipeline and is the first bispecific antibody against PD-L1 and Claudin18.2 to be studied in a U.S. clinical trial. As part of the collaboration, CMAB provided integrated CDMO services for the Q-1802 program, utilizing its antibody production platform. Services included CMC development activities and successful production of drug substance and drug product batches in only 9 months. "We are very glad to collaborate with CMAB. During the Q-1802 program, the two groups worked together and completed the CMC development and production of clinical samples efficiently and rapidly." said Dr. Xiangdong Qu, Founder and CEO of QureBio. "The first-class technology and GMP level, as well as thoughtful services of CMAB team impressed us a lot during our collaboration. We are looking forward to continuing work with CMAB, and we are also striving to bring better innovative dual anti-drugs to patients as soon as possible." Dr. Yongzhong Wang, CEO of CMAB said, "We appreciate the trust of Dr.Qu and QureBio, and congratulation them on having Q-1802 become the world's first bispecific antibody against PD-L1 and Claudin18.2 approved for a clinical trial in the US. There are unique development challenges when dealing with a bispecific antibody and we are very proud of our team who utilized our antibody platform in order to achieve, industry-leading speed to get a US IND approved successfully. It is also a testament to the excellent cooperation between CMAB and QureBio. CMAB will continue to accelerate the process of Q-1802 from QureBio, and look forward to reaching the next milestone early." About QureBio Ltd. QureBio Ltd. was established in July 2017. It is a company incubated by Viva Biotech that focuses on the research and development of innovative macromolecular biopharmaceuticals. The company is registered in the Shanghai Pilot Free Trade Zone. QureBio aims to develop novel therapeutic drugs for the treatment of tumors, autoimmune diseases and metabolic diseases in China and the world to benefit patients. The company has multiple technology platforms for antibody drug development including phage display, hybridoma as well as protein and antibody engineering. In addition, the company's goal is to make effective and robust manufacturing process for biologics. QureBio recently received tens of millions of A + rounds of financing, and the investor is the Shenzhen Capital Group Company, Ltd. ("SCGC"). This round of financing will mainly be used to advance the pre-clinical development of Q-1802 and Q-1801 projects. Q-1802 is a bispecific antibody immunotherapy for solid tumors such as gastric cancer. It has completed three batches of pilot production and is expected to complete the dual IND filings in both China and the United States this year. The Q-1801 project is a bispecific antibody drug targeting the tumor microenvironment signaling pathway. It is expected to complete the clinical declaration in 2021. QureBio Ltd. Address: Room 206, Building 1, No. 1227 Zhangheng Road, No. 1118 Halei Road, Pudong District, Shanghai About CMAB Biopharma (Suzhou), Inc. CMAB is a flexible full-service CDMO dedicated to providing bespoke development manufacturing services of antibodies and biologics for clients in China and across the globe. CMAB complies with global quality standards, we get European commission EudraLex (EMA) Vol 4. GMP guidelines which is a successful external QP Audit by Parexel. To find out more about our dynamic CDMO, please go to the website: CMAB Biopharma (Suzhou) Inc Address: C37&C29, No.188 Dongping Street, Suzhou Industrial Park Tel: 0512-6799 5177 Business Contact: BDChina@cmabbio.com Public Relations: PR@cmabbio.com View original content: SOURCE CMAB Biopharma Limited