HLX49 / Shanghai Henlius Biotech, Fosun Pharma - LARVOL DELTA

A best-in-class HER2xHER2 novel biparatopic antibody-drug conjugate with an efficacious, low-toxicity design that maximizes antibody functionality (AACR 2026) - "When combined with HLX02 (a trastuzumab biosimilar), HLX22 increases internalization of HER2 homodimers and HER2/EGFR heterodimers, reducing cell proliferation signals. This combination shows stronger antitumor effects than HLX02 plus HLX11 (a pertuzumab biosimilar) both in vitro and in vivo...Preliminary toxicology in cynomolgus monkeys was assessed at 60 mg/kg, administered every three weeks for three cycles. The HER2xHER2 biparatopic ADC demonstrated superior internalization efficiency than KN026 (a HER2-targeted bispecific antibody) and trastuzumab deruxtecan in BT474 and NCI-N87 cell lines... We have developed a potential best-in-class HER2xHER2 novel biparatopic ADC that exhibits a superior therapeutic index, antibody-mediated signaling blockade. The preclinical findings support clinical development in breast and gastric cancers, with the hope that the improved therapeutic index of this agent confers survival benefit."

ADC • Gastric Cancer • Oncology • Solid Tumor • EGFR

[AACR] AbClon highlights Henlius' HER2 ADC outperforming Enhertu in a preclinical study (BioNews) - "HLX49 demonstrated superior internalization efficiency and cytotoxic activity compared to Enhertu in both breast cancer (BT-474) and gastric cancer (NCI-N87) cell lines...In particular, results from multiple xenograft animal models showed that a single dose of 6 mg/kg induced marked complete tumor remission (CR). Above all, Henlius reported that HLX49 demonstrated overwhelmingly superior antitumor efficacy compared with Enhertu even in 'HER2 ultra-low expression models (IHC < 1+),' a blind spot of Enhertu....'Our partner's plan to file an Investigational New Drug (IND) application for HLX49 within this year also reflects strong confidence in the candidate.'"

IND • Preclinical • Breast Cancer • Gastric Cancer

At this year’s AACR conference, Henlius will showcase seven early-stage innovative assets with first-in-class (FIC) or best-in-class (BIC) potential. (Henlius Press Release) - "These include...multiple novel ADC candidates developed based on proprietary platform Hanjugator, including the EGFR×cMET bispecific ADC HLX48, HER2 biparatopic ADC HLX49, ADAM9 ADC HLX402, and ALPP/ALPPL2 ADC HLX85."

Preclinical • Oncology