Kivu Bioscience Secures HREC Approval and CTN Clearance for Next-Generation ADC
Why are next-generation antibody-drug conjugates (ADCs) crucial for advancing cancer treatments? Kivu Bioscience, a clinical-stage biotechnology company based in San Mateo, CA, is making significant strides in this area. The company has announced the presentation of new preclinical data for KIVU-305, its CEACAM5-targeted ADC, at World ADC London 2026. Additionally, Kivu has secured 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. This marks a significant milestone as Kivu advances its second ADC candidate into clinical development, further validating its innovative approach to ADC design.
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.” This announcement sets the stage for a deeper exploration of KIVU-305’s potential impact on cancer treatment.
Key Insights at a Glance
- CEACAM5 Expression: CEACAM5 is broadly expressed across multiple solid tumors, including colorectal, pancreatic, and non-small cell lung cancers.
- Improved Stability: KIVU-305 is designed to enhance plasma stability and reduce off-target toxicity.
- Preclinical Success: Preclinical results demonstrate potent target-dependent cytotoxicity and strong anti-tumor efficacy.
- Clinical Trial Initiation: KIVU-305 will enter a Phase 1 study to evaluate safety, tolerability, and preliminary anti-tumor activity.
Why CEACAM5-Targeted ADCs Are Critical for Cancer Treatment
CEACAM5 is a protein widely expressed in various solid tumors, including colorectal, pancreatic, and non-small cell lung cancers. High expression of CEACAM5 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. This highlights the urgent need for next-generation ADCs with improved stability and a wider therapeutic index. Addressing this challenge is crucial for developing more effective treatments for patients with advanced solid tumors.
The Regulatory Clock Is Ticking for KIVU-305
Just as a marathon runner must pace themselves to finish strong, Kivu Bioscience must navigate the complex regulatory landscape to bring KIVU-305 to market. The company’s receipt of HREC approval and CTN clearance in Australia is a critical step in this journey. These regulatory milestones enable Kivu to initiate a first-in-human clinical trial, which will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-305. This trial is essential for validating the company’s innovative ADC design and advancing the treatment of CEACAM5-expressing cancers.
Kivu Bioscience’s Innovative Approach to ADC Design
Kivu Bioscience is advancing KIVU-305, a next-generation CEACAM5-targeted ADC, into clinical trials. The molecule is designed to selectively bind to tumor cells and deliver a potent topoisomerase inhibitor payload. Through site-specific conjugation, Fc-silencing, and optimized linker-payload design, KIVU-305 aims to improve stability, reduce off-target toxicity, and potentially widen the therapeutic window. Preclinical results have shown selective nanomolar binding to CEACAM5-positive tumor cells, potent target-dependent cytotoxicity, and strong anti-tumor efficacy across multiple models. These findings support the advancement of KIVU-305 into a Phase 1 study, where it will be evaluated for its potential to treat advanced CEACAM5-expressing solid tumors.
Future Outlook
The future of cancer treatment is evolving, and Kivu Bioscience is at the forefront of this transformation. The company’s innovative approach to ADC design, exemplified by KIVU-305, is poised to address critical challenges in cancer therapy. As KIVU-305 progresses through clinical trials, the potential for a new, more effective treatment option for patients with CEACAM5-expressing cancers becomes increasingly tangible. The next milestone for Kivu is the Phase 1 study, which will provide crucial insights into the safety and efficacy of KIVU-305.
Conclusion
Kivu Bioscience’s advancement of KIVU-305 into clinical trials represents a significant step forward in the development of next-generation ADCs for difficult-to-treat cancers. For the biotechnology industry, this milestone underscores the importance of innovative drug design and rigorous preclinical testing. For healthcare providers and patients, it offers hope for more effective and safer treatment options. How is your organization preparing to integrate these advancements into your cancer treatment strategies? Join the conversation in the comments below.
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.
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