IBI319 / Innovent Biologics, Eli Lilly - LARVOL DELTA

Phase I study of the efficacy and safety of IBI319 in patients with advanced malignant tumors. (ASCO 2022) - P1a/1b | "IBI319 demonstrates good tolerability in patients with advanced solid tumors or hematological malignancies, with a safety profile characterized by a lack of hepatotoxicity frequently observed with CD137-targeting antibodies."

Clinical • P1 data • Back Pain • Hematological Disorders • Hematological Malignancies • Hepatology • Hodgkin Lymphoma • Lymphoma • Musculoskeletal Pain • Oncology • Pain • Solid Tumor • CRP

Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b | N=256 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2024 ➔ Jun 2023 | Trial primary completion date: May 2024 ➔ Dec 2022

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Innovent Will Present Clinical Data of IBI110 (anti-LAG-3 monoclonal antibody) and Other Multiple Trials at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire-Asia) - "Innovent Biologics...announced that the company will present clinical data from multiple trials in relation to TYVYT (sintilimab injection), Pemazyre (pemigatinib), olverembatinib (BCL ABL TIK), IBI110 (anti-LAG-3 monoclonal antibody), IBI376 (PI3Kδ inhibitor), IBI344 (ROS1/NTRK TKI), IBI351 (KRAS G12C inhibitor) and IBI319 (PD-1/CD137 bispecific antibody) at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, June 3-7, 2022."

Clinical data • P1 data • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Follicular Lymphoma • Gastric Cancer • Gastroesophageal Cancer • Gastrointestinal Cancer • Gastrointestinal Stromal Tumor • Hematological Malignancies • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lymphoma • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Oncology • Sarcoma • Solid Tumor • Thoracic Cancer

Innovent Publishes the Preclinical Results of IBI319 (Anti PD-1/CD137 Bispecific Antibody) in Nature Communications (PRNewswire) - "Innovent Biologics...announced that the preclinical result of IBI319 was published in Nature Communications....In CT26 and MC38 tumor models, compared with PD-1 mAb or CD137 mAb, IBI319 generates synergistic antitumor efficacy by blocking PD-1 and activating CD137 simultaneously. It enhances tumor infiltration of T and NK cells in the absence of signs of hepatotoxicity. A non-human primate GLP toxicology study suggests that IBI319 is a well-tolerated molecule with a good safety profile..."

Preclinical • Oncology

Cancer immune therapy with PD-1-dependent CD137 co-stimulation provides localized tumour killing without systemic toxicity. (PubMed, Nat Commun) - "Besides limiting systemic T cell co-stimulation, the anti-PD-1 arm of IBI319 also exhibits checkpoint blockade functions, with an overall result of T and NK cell infiltration into tumours. Toxicology profiling in non-human primates shows that IBI319 is a well-tolerated molecule with IgG-like pharmacokinetic properties, thus a suitable candidate for further clinical development."

IO biomarker • Journal • Hepatology • Immune Modulation • Inflammation • Oncology • TNFRSF9

Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI319 (Anti-PD-1/CD137 Bispecific Antibody) in Patients with Advanced Malignant Tumors (PRNewswire) - "Innovent Biologics...announced that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific antibody. The objective of this open-label, multi-center Phase 1a/1b dose escalation and expansion study is to evaluate the safety, tolerability, potential optimal dosage and preliminary efficacy of IBI319 in patients with advanced malignant tumors whose cancer progressed on standard-of-care treatment."

Trial status • Oncology

Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b; N=256; Recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Study of the Efficacy and Safety of IBI319 in Patients With Advanced Malignant Tumors (clinicaltrials.gov) - P1a/1b; N=256; Not yet recruiting; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Clinical • New P1 trial • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Newly added product (Innovent Biologics Press Release) - Preclinical, Oncology

Pipeline update • Oncology