Kivu Bioscience announced HREC approval and Clinical Trial Notification (CTN) clearance in Australia to initiate a first-in-human clinical trial for KIVU-305

CAR-T Digest - August 2020

Weekly Digest - February 2026

25 February 2026: Kivu Bioscience announced HREC approval and Clinical Trial Notification (CTN) clearance in Australia to initiate a first-in-human clinical trial for KIVU-305

Kivu Bioscience announced new preclinical data for its CEACAM5-targeted antibody–drug conjugate KIVU-305 at World ADC London 2026, alongside confirmation that it has received Human Research Ethics Committee approval and Clinical Trial Notification clearance in Australia to initiate a first-in-human study
The Australian regulatory clearances mark a key milestone for KIVU-305, which will enter clinical development as the company’s second ADC program and further advance Kivu’s strategy of designing next-generation ADCs with improved stability, potency, and tolerability
KIVU-305 targets CEACAM5, a protein broadly expressed across solid tumors such as colorectal, pancreatic, and non-small cell lung cancers, where high expression is associated with poor prognosis and where earlier ADC approaches have faced limitations due to payload-related toxicity
Preclinical data presented at the conference demonstrated selective tumor cell binding, potent target-dependent cytotoxicity, meaningful bystander activity, strong antitumor efficacy across multiple xenograft models including chemotherapy-resistant tumors and favorable pharmacokinetics with high plasma stability and low free payload levels
These findings support advancement of KIVU-305 into a Phase 1 clinical trial in patients with advanced CEACAM5-expressing solid tumors, where the study will evaluate safety, tolerability, pharmacokinetics, and early signals of antitumor activity