IBI-323 / Innovent Biologics - LARVOL DELTA

LAG-3 antagonists for cancer treatment: an updated patent review (2020-2025). (PubMed, Expert Opin Ther Pat) - "The trend shows that monospecific antibodies against LAG-3 continue to be the main antagonists, followed by multispecific t, treatment methods using known LAG-3 antagonists, LAG-3 binding peptides, and LAG-3 binding small molecules. The monospecific antibodies encelimab, miptenalimab, and the bispecific antibodies tobemstomig, IBI323, ABL501, fanastomig, and FS118 are added, during this period, to the potential drugs targeting LAG-3."

Journal • Review • Oncology • CD4 • CD8 • IFNG • LAG3

Efficacy and Biomarker Explanation of IBI-323 + Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Hunan Province Tumor Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Biomarker • Enrollment open • Trial completion date • Trial primary completion date • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK

Study of IBI323 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1 | N=322 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Study of IBI323 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1; N=322; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI323 (Anti-LAG-3/PD-L1 Bispecific Antibody) in Patients with Advanced Malignant Tumors (PRNewswire) - "Innovent Biologics, Inc...announced that the first patient has been dosed in a Phase 1 study of IBI323, an anti-LAG-3/PD-L1 bispecific antibody. The objective of this open-label, multi-center Phase 1 dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI323 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment."

Trial status • Oncology

PD-L1/LAG-3 bispecific antibody enhances tumor-specific immunity. (PubMed, Oncoimmunology) - "Collectively, these data demonstrated that IBI323 preserved the blockade activities of parental antibodies while processing a novel cell bridging function. Based on the encouraging preclinical results, IBI323 has significant value in further clinical development."

Journal • Immune Modulation • Immunology • Inflammation • Oncology • CD4 • CD8 • LAG3

Study of IBI323 in Patients With Advanced Malignancies (clinicaltrials.gov) - P1; N=322; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

"some mistakes IBI110 belongs to Anti-Lag3 MAb, while IBI323 is Anti-Lag3xPD-L1 bispecific Ab" (,@ksrcristianchen)

Innovent Bio’s LAG-3/PD-L1 BsAb nails tacit clinical nod in China (GBI Health) - "The Center for Drug Evaluation (CDE) website indicates that Innovent Biologics Inc., (HKEX.01801)’s IBI323, a bispecific antibody (BsAb) targeting lymphocyte activation gene-3 (LAG-3) and programmed cell death-ligand 1 (PD-L1), has obtained tacit clinical trial approval. The drug candidate will be assessed in advanced malignant tumors."

Non-US regulatory • Oncology