IBI3019 / Innovent Biologics - LARVOL DELTA

IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies (AACR 2025) - "Inhibition of EGFR signaling is clinically effective in colorectal cancer (CRC) as evidenced by the approval for Cetuximab in combination with chemotherapy or Encorafenib, a BRAF inhibitor, and the promising clinical results when combined with KRAS inhibitors, such as Adagrasib or Sotorasib...Additionally, IBI3019 incorporates a high affinity CD16A single domain antibody that mediates stronger antibody-dependent cell cytotoxicity (ADCC) than IgG1 used in Cetuximab or the low fucosylated Fc of Amivantamab, a bispecific antibody targeting c-MET and EGFR, both in vitro and in vivo...It exhibited strong synergy with Fulzerasib, a KRAS G12C inhibitor and MRTX1133, a KRAS-G12D inhibitor...IBI3019 is a highly optimized FIC molecule with enhanced EGFR blocking capability and ADCC, maximizing tumor inhibition while minimizing toxicity. Its superior efficacy and safety profile support further clinical evaluation."

Preclinical • Trispecific • Colorectal Cancer • Oncology • Solid Tumor • CDH17 • FCGR3A • KRAS • MET

Topic: IBI3019, a first-in-class EGFR/CDH17/CD16A tri-specific antibody, demonstrated potent efficacy against CRC and an excellent safety profile in preclinical studies (PRNewswire) - "Innovent Biologics...announces that preclinical data...from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025....IBI3019...demonstrated strong tumor-specific EGFR inhibition by targeting the overexpressed CDH17 on tumors, while significantly reducing skin toxicities commonly associated with EGFR therapies. Additionally, IBI3019 incorporates a high-affinity CD16A nanobody that showed better antibody-dependent cell cytotoxicity than those mediated by low-fucose Fc. Importantly, IBI3019 not only demonstrated superior in vitro and in vivo anti-tumor efficacy to Cetuximab and Amivantamab but was also highly tolerable in cynomolgus monkeys with HNSTD at 150 mg/kg in a pilot tox study."

Preclinical • Solid Tumor

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2025 AACR Annual Meeting (PRNewswire) - "Innovent Biologics...announces that preclinical data on multiple novel bispecific antibodies as well as antibody-drug-conjugates (ADCs) from its oncology pipeline will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025."

Preclinical • Acute Myelogenous Leukemia • T Acute Lymphoblastic Leukemia