IBI3019 / Innovent Biologics - LARVOL DELTA

The Trispecific Antibody IBI3019 Integrates CDH17-Enhanced EGFR Antagonism with Optimized CD16A Engagement to Elicit Potent Antitumor Activity with Minimal Toxicity. (PubMed, Cancer Res) - "This "anchor and capture" mechanism allowed the EGFR/CDH17 bsAb to achieve superior and more sustained suppression of the EGFR pathway than cetuximab and amivantamab. It demonstrated superior in vivo efficacy and a good safety profile in cynomolgus monkeys, with no observable skin toxicity. These promising pre-clinical findings warrant the clinical development of IBI3019. ."

Journal • Colorectal Cancer • Dermatology • Oncology • Solid Tumor • CDH17 • EGFR • FCGR3A • MET • PTPRC

A novel CD16A-nanobody platform overcomes Fc polymorphism limitations for potent and broad-spectrum NK cell engager therapeutics (AACR 2026) - "Immunogenicity assessment in PBMCs from 45 HLA-diverse healthy donors showed low anti-drug antibody (ADA) rates for IBI3019, which incorporates the CD16A nanobody platform. The ADA rate is comparable to that of trastuzumab and significantly lower than atezolizumab. The CD16A nanobody integrates seamlessly into the antibody architecture, offering superior stability over scFv formats and straightforward CMC manufacturing akin to standard bispecifics, without specialized glycoengineering or licensing. This versatile, high-performance platform exemplifies the next-generation NK cell engagers, delivering broad patient coverage and superior therapeutic potential."

IO biomarker • Late-breaking abstract • Oncology • CDH17 • EGFR • FCGR3A • PD-L1 • PTPRC

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...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