China-based TG ImmunoPharma Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its bispecific antibody (BsAb) TGI-6 in China. This approval marks a significant milestone in the development of innovative cancer treatments within the country.
Mechanism of Action and Design of TGI-6
TGI-6 is designed to specifically bind to both tumor-associated antigens on the surface of tumor cells and CD3 molecules on the surface of T cells. This dual-action mechanism strongly activates T cells and induces the killing of tumor cells. The drug’s design features high-affinity binding to tumor targets and low-affinity binding to CD3, which allows for potent anti-tumor activity while reducing the risk of cytokine release syndrome, commonly known as a cytokine storm.
Comparative Advantages and Collaborations
Compared with the only other CD3 BsAb currently in Phase I, TGI-6 demonstrates higher anti-tumor activity and safety. This positions TGI-6 as a promising candidate in the field of immuno-oncology. Partners Caidya (formerly dMed-Clinipace) and GenScript ProBio provided essential support for the IND filing and pre-clinical CMC services, respectively, highlighting a collaborative approach to advancing the drug through the development pipeline.
Conclusion
The NMPA’s approval to proceed with the Phase I clinical study for TGI-6 is a testament to the potential of TG ImmunoPharma’s innovative approach to cancer treatment. This step forward in clinical development brings the company closer to offering a new therapeutic option for patients with cancer, emphasizing the importance of continued research and development in the biopharmaceutical sector.-Fineline Info & Tech
