Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors

Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors.

BAT8008 is an innovative ADC that consists of a recombinant humanized anti-Trop2 antibody linked to a toxic small molecule topoisomerase I inhibitor via a self-developed cleavable linker. This ADC demonstrates potent anti-tumor activity, with the toxin small molecule exhibiting a strong bystander effect that can effectively overcome tumor tissue heterogeneity. BAT8008 also boasts good stability and safety, with extremely low release of small toxin molecules in plasma, thereby reducing the risk of off-target toxicity. Non-clinical evaluations have indicated that BAT8008 has a favorable safety profile.

BAT1308, on the other hand, is an in-house developed PD-1 monoclonal antibody (mAb) that binds to PD-1 on the surface of T cells, alleviating the immune inhibitory effect of the PD-1 pathway. This action helps restore and enhance T cell immune killing function, thereby inhibiting tumor growth.- Flcube.com

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