Kivu Bioscience Advances Novel Cancer Drug into Human Trials

SAN MATEO, CA – February 25, 2026 – Kivu Bioscience is advancing its second precision cancer therapy into human trials, marking a significant step in the development of next-generation treatments for aggressive solid tumors. The company announced it has received regulatory clearance in Australia to begin a Phase 1 clinical study for KIVU-305, an antibody-drug conjugate (ADC) targeting a key protein found in colorectal, pancreatic, and lung cancers.

The announcement coincided with the presentation of promising preclinical data for KIVU-305 at the prestigious World ADC London 2026 conference, a leading global forum for ADC development. This dual milestone highlights the company's rapid progress in translating its innovative drug design platform into potential new medicines for patients with limited options.

Engineering a Smarter, Safer "Smart Bomb"

Antibody-drug conjugates are often described as "biological smart bombs," designed to deliver potent chemotherapy payloads directly to cancer cells while sparing healthy tissue. However, the first generations of these complex drugs have often been hampered by instability, leading to premature release of the toxic payload and causing significant side effects that can limit their effectiveness. Kivu Bioscience aims to solve this long-standing challenge with KIVU-305.

The drug candidate is built on a sophisticated engineering platform designed to maximize stability and precision. It employs several key technologies, licensed from the Dutch firm Synaffix, to create a more stable and targeted ADC. One core component is the GlycoConnect® technology, which allows for the precise attachment of the drug payload to a specific site on the antibody. This site-specific conjugation creates a highly uniform product and inherently "silences" the antibody's Fc region, which can trigger unwanted immune responses and off-target toxicity in healthy tissues.

This is coupled with a HydraSpace® linker, a highly polar spacer that further enhances the drug's stability in the bloodstream. The goal is to ensure the ADC remains intact until it reaches its destination. By minimizing the amount of "free payload" circulating in the body, this design is expected to create a much wider therapeutic window—the sweet spot between a dose that is effective and one that is too toxic.

"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."

The preclinical data presented in London supports this design philosophy, demonstrating that KIVU-305 had favorable pharmacokinetics, high plasma stability, and low free payload concentrations in non-human primate studies.

Targeting a High-Value, High-Risk Cancer Marker

KIVU-305 is designed to seek out and destroy tumor cells that express a protein called carcinoembryonic antigen-related cell adhesion molecule 5, or CEACAM5. This protein is highly expressed on the surface of several difficult-to-treat cancers, including colorectal, pancreatic, and non-small cell lung cancers, where its presence is often linked to a poor prognosis.

While its prevalence makes CEACAM5 an attractive target, the path to a successful therapy has been fraught with challenges. The target has been clinically validated, but previous attempts to develop CEACAM5-directed ADCs have struggled to find the right balance between efficacy and safety. For instance, Sanofi's tusamitamab ravtansine program was discontinued in late 2023 after failing to show a significant benefit over standard chemotherapy in a late-stage trial.

This history of setbacks highlights the critical need for innovation in ADC design. The competitive landscape includes Merck KGaA, which is advancing its own CEACAM5-targeting ADC, M9140, in clinical trials. Kivu's entry into the space with KIVU-305 is predicated on the belief that its next-generation technology can overcome the toxicity issues that have limited earlier candidates. The preclinical results are encouraging, showing not only potent cancer-killing activity in lab models but also strong efficacy in patient-derived tumors, including those resistant to conventional chemotherapy.

A Strategic Path from Lab to Clinic

The advancement of KIVU-305 into the clinic is not just a scientific milestone but also a validation of Kivu Bioscience's corporate strategy. It is the company's second ADC to reach this stage, following KIVU-107 which began Phase 1 trials in January 2026. This demonstrates the productivity of its platform and its ability to build a robust pipeline, a key factor for investors who backed the company with a $92 million Series A financing round in 2024.

The decision to initiate the first-in-human trial in Australia is also a calculated strategic move. Australia has become a premier destination for early-phase biotechnology trials due to its efficient regulatory framework. The Clinical Trial Notification (CTN) scheme allows companies to begin studies rapidly after receiving approval from a Human Research Ethics Committee (HREC), often much faster than in the United States or Europe.

Furthermore, the Australian government's generous R&D tax incentive can provide a rebate of up to 43.5% on eligible trial-related expenditures, making it a highly cost-effective path for clinical development. Crucially, the high-quality data generated in Australian trials is accepted by major global regulatory bodies like the U.S. Food and Drug Administration (FDA), smoothing the path for subsequent global studies.

With KIVU-305 now entering its Phase 1 study, researchers will begin evaluating its safety, tolerability, and preliminary anti-tumor activity in patients with advanced CEACAM5-expressing cancers. The trial represents a critical test of whether Kivu's sophisticated engineering can translate from promising preclinical models into a meaningful new treatment for patients who desperately need better options.