IBI-334 / Innovent Biologics - LARVOL DELTA

B7-H3-mediated cis-inhibition of EGFR by a tumor-selective bispecific antibody enhances anti-tumor efficacy and minimizes toxicities. (PubMed, Nat Commun) - P1/2 | "Toxicological evaluations in non-human primates reveals a favorable safety profile, with no EGFR-related adverse effects observed at doses up to 120 mg/kg over 4 weeks. Supported by these preclinical findings, IBI334 has advanced to a phase 1 clinical trial (NCT05774873) for advanced/metastatic solid tumors."

Journal • Oncology • Solid Tumor • CD276 • EGFR • KRAS

The Primary Objective of This Study to Evaluate the Safety and Tolerability of IBI334 and Determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D)and Anti Tumor Activity of IBI334. (clinicaltrials.gov) - P1/2 | N=28 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed | N=128 ➔ 28 | Trial completion date: Jun 2026 ➔ Mar 2025 | Trial primary completion date: Oct 2025 ➔ Mar 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

IBI3001: A potentially first-in-class site-specifically conjugated B7-H3/EGFR bispecific ADC for multiple solid tumors (AACR 2024) - "We previously demonstrated in IBI334 (B7-H3/EGFR bsAb) study that (1) B7-H3 and EGFR are co-expressed in multiple solid tumors; (2) B7-H3-aided EGFR signaling inhibition was significantly more potent than Zalutumumab (EGFR mAb) and Amivantamab (c-met/EGFR bsAb); and (3) IBI334 has favorable safety profile in cynomolgus monkey at 120 mg/kg/week. IBI3001 has a favorable PK profile in BALB/c mice with the half-life at 282 hours, and is well-tolerated in cynomolgus monkeys up to 90 mg/kg/week. In conclusion, IBI3001 is a novel bispecific ADC that demonstrated strong anti-tumor efficacy cross multiple solid tumors, and has excellent PK and safety profile."

Late-breaking abstract • Breast Cancer • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CD276 • EGFR • MET

IBI334, a novel ADCC-enhanced B7-H3/EGFR bispecific antibody, demonstrated potent pre-clinical efficacy in solid tumors (AACR 2024) - "Antibodies that inhibit EGFR signaling, such as Cetuximab, show clinical efficacy but are associated with on-target toxicities that potentially limit the drug efficacy...With the aid of B7-H3, IBI334 showed enhanced EGFR signal inhibition than Zalutumumab (EGFR mAb) and Amivantamab (c-met/EGFR bsAb)...In conclusion, IBI334 is a potent B7-H3/EGFR bispecific antibody with broad application in many EGFR-driven solid tumors. The large therapeutic window enables safe and effective cancer treatment at high exposure levels."

Late-breaking abstract • Preclinical • Colorectal Cancer • Esophageal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • CD276 • KRAS • MET

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2024 AACR Annual Meeting (PRNewswire) - "With the aid of B7-H3, IBI334 showed better tumor growth inhibition in vitro and in vivo than EGFR monoclonal antibody and c-met/EGFR bispecific antibody benchmarks....IBI334 has a favorable safety profile with the highest non-severely toxic dose (HNSTD) in cynomolgus monkeys at 120 mg/kg and a large therapeutic window of > 200 folds."

Preclinical • Oncology • Solid Tumor

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=128 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Phase classification: P1 ➔ P1/2

Phase classification • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • RAS

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=128 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • RAS

Innovent Biologics (01801) EGFR/B7-H3 bisantibody obtained clinical approval (Investing.com) - "Zhitong Finance APP was informed that on September 11, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of China announced that the Class 1 new drug IBI334 applied by Innovent Biologics (01801) has obtained implicit approval for clinical trials and is intended to be used to treat unresectable , patients with locally advanced or metastatic solid tumors....The official website of ClinicalTrials shows that Innovent is conducting a Phase 1 study of IBI334 in patients with unresectable, locally advanced or metastatic solid tumors."

New P1 trial • Oncology • Solid Tumor

IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=128 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • RAS