- Receives Australian HREC Approval and CTN Clearance for First-in-Human Study

Kivu Bioscience, Inc., a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, today announced the presentation of new preclinical data for KIVU-305, its CEACAM5-targeted ADC, at World ADC London 2026.

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. KIVU-305 will enter clinical development as Kivu’s second ADC program and further validate the company’s differentiated approach to designing ADCs with improved stability, potency, and tolerability.

“Presenting these data at World ADC London while also securing Australian HREC approval and CTN clearance marks a significant milestone for Kivu as we advance our second ADC candidate into the clinic,” said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. “KIVU-305 reflects our focus on improving ADC stability and tumor exposure while minimizing free payload toxicity, and we look forward to evaluating its potential to deliver a differentiated treatment option for patients with CEACAM5-expressing cancers.”

CEACAM5 is broadly expressed across multiple solid tumors, including colorectal, pancreatic, and non-small cell lung cancers, where high expression is associated with poor prognosis and reduced overall survival. Despite prior validation of CEACAM5-directed ADCs, toxicity related to payload release has limited therapeutic benefit, highlighting the need for next-generation designs with improved stability and a wider therapeutic index.

KIVU-305 is a next-generation CEACAM5-targeted ADC composed of a humanized antibody conjugated via site-specific GlycoConnect^® technology to a HydraSpace^®-linked SYNtecan E^™ topoisomerase inhibitor payload. The molecule incorporates an Fc-silenced antibody and optimized DAR4 configuration designed to enhance plasma stability, reduce Fc-mediated immune activity, enable higher intact ADC tumor exposure, and lower circulating free payload levels.

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
• Strong anti-tumor efficacy across multiple cell-line-derived and patient-derived xenograft models, including chemotherapy-resistant tumors
• Favorable pharmacokinetics, high plasma stability, and low free payload concentrations
• Encouraging tolerability in repeat dose studies in non-human primates

These findings support advancement of KIVU-305 into a Phase 1 study evaluating safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced CEACAM5-expressing solid tumors.

About KIVU-305

KIVU-305 is a next-generation CEACAM5-targeted antibody-drug conjugate engineered to selectively bind tumor cells and deliver a potent topoisomerase inhibitor payload. Through site-specific conjugation, Fc-silencing, and optimized linker-payload design, KIVU-305 is designed to improve stability, reduce off-target toxicity, and potentially widen the therapeutic window in patients with advanced solid tumors.

About Kivu Bioscience

Kivu Bioscience is a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for oncology. Kivu’s ADC platform is built on a design philosophy aimed at improving linker stability, optimizing drug-to-antibody ratio, and increasing delivery of intact ADC to tumors while reducing systemic toxicity. This strategy is intended to expand the therapeutic window and enable more effective treatment of heterogeneous solid tumors. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing innovative therapies for patients with cancer. Kivu is headquartered in San Mateo, CA. For more information, visit www.kivubioscience.com.

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