IBI3001 / Innovent Biologics, Takeda, Fortvita Biologics - LARVOL DELTA

Safety and efficacy of IBI3001, an anti-EGFR/B7H3 bispecific ADC, in patients (pts) with advanced solid tumors: Results of a multi-regional phase 1 study (ESMO 2026) - No abstract available

ADC • Bispecific • Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD276

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."

ADC • Bispecific • 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

Innovent Biologics Announces Closing of Global Strategic Partnership with Takeda for Next-Generation IO and ADC Therapies (PRNewswire) - "Takeda will pay Innovent an upfront payment of US$1.2 billion, including a US$100 million equity investment in Innovent through new share issuance at premium, i.e., HK$112.56 per share. Furthermore, Innovent is eligible for development and sales milestone payments for IBI363, IBI343, and IBI3001 (if option exercised) totaling up to approximately $10.2 billion, for a total deal value of up to $11.4 billion. Innovent is also eligible to receive potential royalty payments for each molecule outside Greater China, except with respect to IBI363 in the U.S...."

Licensing / partnership • Solid Tumor

IBI3001 (EGFR/B7H3 ADC): Option to Global License for Development and Commercialization (PRNewswire) - "Innovent will grant Takeda an exclusive option to license global development, manufacturing, and commercialization rights for IBI3001 outside of Greater China. If exercised, Takeda will pay Innovent an exercise fee, potential milestone payments, and tiered royalties on net sales up to mid-teens."

Licensing / partnership • Solid Tumor

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=250 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting | Phase classification: P1/2 ➔ P1 | N=180 ➔ 250 | Trial completion date: May 2027 ➔ Dec 2027 | Initiation date: May 2024 ➔ Dec 2024 | Trial primary completion date: May 2026 ➔ Dec 2026

Enrollment change • Enrollment open • Metastases • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • Oncology • Solid Tumor

Innovent Biologics’ new dual-antibody ADC cancer drug approved for clinical trials in China [Google translation] (vbdata.cn) - "Innovent Biologics' new bispecific ADC drug IBI3001 has been approved for clinical trials in China. It targets B7-H3 and EGFR, has multiple anti-tumor mechanisms, shows good efficacy and safety, and has been conducting a Phase 1/2 study in Australia."

New trial • Oncology • Solid Tumor

Innovent Biologics (01801) has received clinical trial application for IBI3001, a Class 1 new drug with multiple anti-tumor mechanisms [Google translation] (Sina Corp) - "...the official website of the Drug Evaluation Center (CDE) of the China National Medical Products Administration (NMPA) announced that the clinical trial application for the new drug IBI3001 of Innovent Biologics (01801) Class 1 new drug was accepted."

New trial • Oncology

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2024 AACR Annual Meeting (PRNewswire) - "IBI3001 has multiple anti-tumor mechanisms of action: (1) enhanced EGFR signaling blockade; (2) EGFR- and B7-H3-aided payload internalization and cytotoxicity; and (3) potent bystander killing effects of ADC. The optimized B7-H3 arm not only enhances the EGFR signaling blockade but also reduces EGFR on-target toxicities. IBI3001 showed strong anti-tumor efficacy in vitro and in vivo across multiple solid tumors and is well tolerated with the therapeutic index at 40."

Preclinical • Oncology • Solid Tumor

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=180 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Metastases • New P1/2 trial • Oncology • Solid Tumor

Innovent to Present Preclinical Data of Multiple Novel Molecules at the 2024 AACR Annual Meeting (PRNewswire) - "Innovent Biologics, Inc...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 2024. The AACR meeting will take place April 5-10, 2024, in San Diego, California."

Preclinical • Oncology • Solid Tumor