Weekly Digest - August 2025
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
CAR-T Digest - August 2020
Weekly Digest - August 2025
07 August 2025: Henlius to initiate a Phase 1 multicenter study in US of its PD-L1 ADC HLX43 for the treatment of thymic carcinoma
- The U.S. FDA has approved Henlius to initiate a Phase 1 multicenter trial of HLX43, a PD-L1-targeting antibody-drug conjugate (ADC), in thymic carcinoma (TC), adding to its ongoing global Phase 2 program in advanced NSCLC
- HLX43 is the first PD-L1 ADC to reach Phase 2 development globally, showing high efficacy and low toxicity across multiple solid tumors, including NSCLC and thymic squamous cell carcinoma (TSCC)
- In Phase 1 results presented at ASCO 2025, HLX43 demonstrated a manageable safety profile and strong efficacy, with a 75% ORR (3/4 patients) in TSCC
- The ADC combines a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker, and a topoisomerase inhibitor payload (DAR ≈ 8), delivering targeted cytotoxicity and immune checkpoint blockade for synergistic anti-tumor effects
