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Kivu Bioscience Presents Preclinical Data for KIVU-107 Demonstrating Potent and Durable Anti-Tumor Activity and a Wide Therapeutic Index at World ADC San Diego 2025

via Business Wire

KIVU-107 is the first PTK7-targeting ADC with a DAR4 exatecan payload, engineered for exceptional stability and highly selective on-tumor delivery.

Preclinical data demonstrate deeper and durable anti-tumor activity across multiple xenograft models, with a wide therapeutic index and well-tolerated profile in repeat-dose GLP studies.

Kivu to initiate a Phase 1 clinical study of KIVU-107 this quarter.

Kivu Bioscience, a biotechnology company advancing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, today announced that it will present new preclinical activity and safety data for KIVU-107, a best-in-class PTK7-targeting ADC, at the 16th World ADC San Diego, held November 3-6, 2025. The data will be featured in both an oral and poster presentation highlighting the unique biophysical and therapeutic properties of KIVU-107, and its potential to set a new standard among next-generation ADCs.

KIVU-107 is a PTK7-targeting ADC generated via site-specific GlycoConnect™ and HydraSpace™ conjugation technologies. It is designed to be highly stable in circulation, with negligible free payload release, maximizing on-tumor activity while minimizing off-target toxicity. The ADC leverages an exatecan payload (SYNtecan E™) with an optimized drug-antibody ratio (DAR), resulting in a wider therapeutic index and deeper, more durable responses in preclinical tumor models.

“These preclinical data highlight the potential of KIVU-107 as a next-generation ADC designed to deliver enhanced efficacy, superior stability, and improved tolerability,” said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. “In preclinical studies, KIVU-107 is both highly potent and exceptionally well-tolerated, a combination that’s rare among ADCs. We look forward to initiating our Phase 1 clinical trial this quarter.”

Both the oral and poster presentations feature preclinical data highlighting KIVU-107’s strong anti-tumor activity, and excellent safety profile. KIVU-107 demonstrated potent antigen-specific cytotoxicity with rapid internalization in vitro and. in mouse xenograft models, durable complete tumor regressions were observed after a single dose. KIVU-107 also showed robust activity in combination with olaparib and in ADC-resistant patient-derived xenograft models, supporting its potential to overcome resistance mechanisms seen with current ADC therapies.

Repeat-dose GLP toxicology studies in non-human primates demonstrated favorable pharmacokinetics, minimal unconjugated exatecan exposure, and an exceptional tolerability profile supporting a potential higher starting dose for first-in-human evaluation. Together, these findings confirm a wide therapeutic index and a best-in-class potential for efficacy, stability, and safety.

The preclinical data collectively demonstrate that KIVU-107 combines precision targeting with a potent and controllable payload, resulting in a differentiated ADC profile with a remarkably wide therapeutic index.

Presentation Details:

Oral Presentation

  • Title: Striving for Kinder and Gentler ADCs: Spotlight on Solid Tumor Target and Preclinical Development of KIVU-107
  • Presenter: Mohit Trikha, Ph.D.
  • Session: Discovery Biology
  • Date/Time: Tuesday, November 4, 3:00 PM PT

Poster Presentation

  • Title: Preclinical Efficacy and Safety of KIVU-107, a Novel PTK7-Targeting Antibody-Drug Conjugate (ADC)
  • Authors: N. Viller, L. Zhang, X. Jiang, A. MacLaren, M. Trikha
  • Session: Day 2 Poster Session
  • Poster Number: 84
  • Date/Time: Wednesday, November 5, 8 AM – 6 PM PT

About Kivu Bioscience

Kivu Bioscience is pioneering next-generation antibody-drug conjugates (ADCs) in oncology. The company’s proprietary linker-payload technology delivers enhanced safety and efficacy, minimizing off-target effects to improve patient outcomes. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing its lead candidates to clinical trials. The company is headquartered in San Mateo, CA. For more information, visit www.kivubioscience.com.

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