- CMAB completed a full scope development and manufacturing project for Q-1802 in 9 months for dual IND filing in China and the US
- Completion of the project demonstrates the significant speed to clinic achievable with CMAB's fully integrated development and manufacturing platform
- QureBio's bispecific antibody Q-1802 will enter clinical trials to assess treatment of solid tumors such as gastric cancer
SUZHOU, China, May 13, 2020 /PRNewswire/ -- CMAB Biopharma (Suzhou) Inc. ("CMAB"), a company exclusively focused on delivering contract development and manufacturing services for biologics, and QureBio Ltd. ("QureBio") announced today that CMAB has successfully completed the development and manufacturing of QureBio's bispecific antibody Q-1802 in only 9 months through its fully integrated platform. The filing package and drug product conforms to requirements necessary to submit IND's in both China and the United States. Q-1802 is a bispecific antibody being studied for the treatment of solid tumors such as gastric cancer.
CMAB employed a full complement of integrated services to successfully complete the rapid development and manufacturing of Q-1802. Accelerated cell line development resulted in an expression level exceeding 4 g/L while parallel process and formulation development work saved time in the initial development phase. Pilot scale up allowed CMAB's drug substance (DS) and drug product (DP) teams to complete three 200 L DS batches in single-use bioreactors and three corresponding lyophilized DP batches within the 9 month timeline. The last batch was performed under CGMP and is expected to be fully released within 2 months. Through the coordinated and integrated actions of all departments within CMAB, the Q-1802 project provides a further demonstration and confirmation of CMAB's development and manufacturing platform for time sensitive projects.
Dr. Yejie Du, Vice President of QureBio and Head of CMC said: "Q-1802 is a bispecific antibody researched and developed based on QureBio's own technology platform. On the basis of maintaining a high level of bioactivity, it ensures that the bispecific antibodies are of good quality and of high output. The professional process development and project management team of CMAB worked closely with us to actively propose and implement solutions that enable us to quickly achieve important milestones and enable QureBio to gain a stronger competitiveness. The two parties will continue to work together to accelerate the dual IND filings in both China and the United States, and quickly push the major products of QureBio to the clinical trial, bringing more effective drugs to the patients."
Dr. Xiangdong Qu, Founder of QureBio said: "QureBio uses the concept of 'Quality by Design' to embed developability evaluation into early molecular design and evaluation. The smooth development of the project is the verification of this concept. The advanced integrated technology platform and coordinated project management capabilities of CMAB have prompted the efficient completion of the CMC of the project."
Dr. Yongzhong Wang, CEO of CMAB said: "Despite the recent challenges imposed by the ongoing pandemic, CMAB was able to deliver on our committed timeline while at the same time, protecting the safety of our staff. Based on our integrated biopharmaceutical development platform and technology, we are proud to have helped QureBio successfully complete their Q-1802 project, pre-clinical CMC process development and production. We are very glad to help innovative drug companies such as QureBio to advance their bispecific projects and hope it can benefit cancer patients as quickly as possible."
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 and has received angel investment. The goal of QureBio is to develop new therapeutic drugs for the treatment of refractory cancer, 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 technology platforms and hybridoma antibodies technology platform and monoclonal antibody platform, etc.
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.
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About CMAB Biopharma Inc.
CMAB Biopharma Inc. is a flexible full-service CDMO dedicated to providing bespoke development and manufacturing services of antibodies and biologics for clients in China and across the globe. Our adaptable, service-oriented business enables clients to take their innovative concepts for tomorrow's medicines from DNA to CGMP product today.
CMAB Biopharma (Suzhou) Inc.
Building C37 & C29 (F1), No.188 Dongping Street, Suzhou Industrial Park, China
Tel: +86 512 6799 5177
Email: [email protected]
SOURCE CMAB Biopharma Limited