Shanghai-based biotech firm ITabMed Ltd has announced the receipt of Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate, A-337. A-337 is a CD3-activating bispecific antibody (BsAb) targeting EpCAM, a tumor-associated antigen (TAA) that is up-regulated and over-expressed in many solid tumor types, particularly epithelial cancers. This approval paves the way for a Phase I, open-label dose-escalation study to evaluate A-337 in patients with advanced solid tumors.
A-337: A Promising Therapy for Advanced Solid Tumors
ITabMed’s A-337 is designed with two EpCAM targeting fragments (EpCAM x EpCAM x CD3), which produces significantly enhanced properties and an improved safety profile compared to competitor products, including EpCAM x CD3 TCE and EpCAM x CD3 bispecific antibodies. The molecule has successfully completed preclinical testing and is poised to enter clinical trials, offering a potentially effective treatment option for patients with EpCAM-positive solid tumors.
ITabMed’s iTab T Cell Engager (TCE) Platform
ITabMed is established around its iTab T cell engager (TCE) platform, which specializes in human CD3-activating bi- and tri-specific antibodies targeting TAAs. A-337 is the second molecule to be generated using this platform, following A-319, a CD19/CD3 BsAb. The platform’s innovative approach to engaging T cells with TAAs has shown promising results in preclinical studies, indicating a strong potential for clinical success.
Company Background and Financing
ITabMed was established in 2021 through a joint venture with Evive Biotech (formerly Generon BioMed Ltd) and Dr. Xiaoqiang Yan. The firm closed a Series A financing round for USD 20 million in December 2021, highlighting the confidence of investors in the company’s innovative approach to antibody development.-Fineline Info & Tech
