On December 29 of 2021, BioHeng and PPC GROUP, a leading biotechnology clinical research CRO company in the Asia-Pacific region, signed a clinical strategy and development cooperation agreement in the field of cell therapy and gene therapy, and will carry out registered clinical trials in China to evaluate BioHeng CTA101 and UCAR-T The safety and effectiveness of cell injection products.
Through this strategic cooperation, the two parties will integrate their respective professional management teams and technical platforms and other advantages to jointly provide full support for BioHeng's clinical research. According to the agreement, BioHeng and PPC GROUP will immediately carry out the next clinical trial for the CTA101 UCAR-T cell injection product to evaluate the safety and effectiveness of CTA101 in the treatment of r/r B-ALL.
BioHeng CMO Dr. Chen Jie said: CTA101 is our first-generation universal CAR-T product based on CRISPR gene editing technology. Compared with autologous CAR-T, UCAR-T can significantly shorten the treatment cycle and reduce costs. The clinical cooperation with PPC GROUP will further promote the development of universal CAR-T. We hope to understand and develop new cell therapies in order to solve the bottleneck of immune cell therapy drugs and improve their safety and effectiveness.
Mr. Liu Hansong, General Manager of PPC GROUP China expressed his congratulations to BioHeng for completing the submission of the first clinical trial application (IND) for the first universal CAR-T injection in China last week. “This is undoubtedly a milestone achievement for the entire cell therapy industry. BioHeng and PPC GROUP, in line with the goal of complementary advantages and win-win development, reached a consensus on this strategic cooperation. At the same time, working with BioHeng this time, we hope that through PPC GROUP's years of experience in the field of cell therapy, clinical trials can be accelerated and benefit the majority of patients as soon as possible.”, Liu said.
The CTA101 UCAR-T (Universal CAR-T) cell injection product independently developed by BioHeng has been accepted for clinical trial applications by the Center for Drug Evaluation (CDE) of the State Drug Administration of China. CTA101 is a universal cell therapy product that is expected to become "first-in-class" in China. It can be used to treat relapsed/refractory B-cell acute lymphoblastic leukemia in CD19 and/or CD22-positive adults. CTA101 is also a dual-target universal CAR-T cell therapy based on CRISPR/Cas9 gene editing program developed by BioHeng's first-generation universal CAR-T technology platform, "off-the-shelf", anti-CD19/CD22 dual-target universal CAR-T cell therapy. Our data suggests its good tolerability and potent anti-tumor effect.
About PPC GROUP
PPC GROUP was established in 1997. It is a contract research organization (CRO) focusing on providing one-stop professional services for drug clinical research. The scope of services includes registration consulting, medical affairs, clinical monitoring, project management, and data Management, statistical analysis and drug safety alert. PPC GROUP is headquartered in Shanghai, China, and provides comprehensive clinical research and laboratory services in China, Taiwan, South Korea and Japan. PPC GROUP has 1 phase I clinical research center, 4 biological analysis laboratories and 1 central laboratory.
Founded in 1996, Novotech is the largest contract research organization (CRO) in the Asia-Pacific region. Novotech's service scope covers Australia, New Zealand and Asia, and its service quality has been recognized by customers and the industry.
In October 2020, two leading Asian contract research organizations (CROs)-Novotech and PPC GROUP merged to form Novotech Health Holdings, aiming to build a fully integrated contract research organization (CRO) with multi-regional coverage. Platform to meet the fast-growing demand for high-quality clinical trial services in Asia. The combined new company will become Asia's largest biotechnology professional CRO platform, which can provide comprehensive clinical services from the first human to phase IV clinical research. Novotech Health Holdings currently has an international professional team of more than 2,075 people and 21 offices in 14 countries and regions.
Source: Bioheng website