KIVU-305 / Kivu Bioscience - LARVOL DELTA

Preclinical efficacy and safety of KIVU-305, a novel CEACAM5-targeting antibody-drug conjugate (ADC) for colorectal cancer (CRC) (AACR 2026) - "The first-generation CEACAM5 ADC labetuzumab govitecan demonstrated clinical feasibility but with limited efficacy at tolerable doses, highlighting the opportunity for an improved ADC with more stable linker payload to provide superior clinical benefit.KIVU-305 is a CEACAM5-targeting ADC composed of a humanized monoclonal antibody conjugated to SYNtecan E™ via the GlycoConnect®/ Hydraspace® (GC/HS) site-specific conjugation technology, delivering an exatecan-based topoisomerase I inhibitor payload at an average drug-to-antibody ratio (DAR) of 4...In vivo, KIVU-305 induced sustained tumor regressions in multiple CEACAM5-positive CRC and PDAC xenograft models, including models resistant to irinotecan...No on-target toxicities were identified, consistent with historical CEACAM5 ADC experience.Collectively, these data support KIVU-305 as a promising CEACAM5-directed ADC with a favorable safety profile that may provide an improved therapeutic index. A Phase I..."

ADC • Preclinical • Colorectal Cancer • Gastric Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CEACAM5

A Study of KIVU-305 in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=76 | Not yet recruiting | Sponsor: Kivu Bioscience Inc.

First-in-human • New P1 trial • Oncology • Solid Tumor

Kivu Bioscience to Present Preclinical Data on Next-Generation ADC Programs at AACR Annual Meeting 2026 (Businesswire) - "Clinical-stage PTK7 ADC KIVU-107 shows strong preclinical anti-tumor activity, favorable pharmacokinetics and improved tolerability....KIVU-305 demonstrates potent preclinical activity and enhanced stability across colorectal and other solid tumor models....KIVU-305 is a next-generation ADC targeting CEACAM5...with a Phase 1 clinical trial in patients with advanced solid tumors planned for 2026."

New P1 trial • Preclinical • Colorectal Cancer

Kivu Bioscience Presents KIVU-305 Preclinical Data at World ADC London 2026 and Advances into Phase 1 Clinical Trial (Businesswire) - "Preclinical results presented at World ADC London demonstrated: Selective nanomolar binding to CEACAM5-positive tumor cells with efficient internalization; Potent target-dependent cytotoxicity and meaningful bystander killing activity....Kivu also announced another significant milestone with receipt of Human Research Ethics Committee (HREC) approval and Clinical Trial Notification (CTN) clearance in Australia to initiate a first-in-human clinical trial for KIVU-305."

First-in-human • New P1 trial • Preclinical • Solid Tumor