Kivu Bioscience Initiates First-in-Human Trial of KIVU-107, Next-Generation PTK7-Targeting ADC for Advanced Solid Tumors
核心洞察
Kivu Bioscience (搜索) has dosed the first patient in a Phase 1 clinical trial of KIVU-107 (搜索), a next-generation PTK7 (搜索)-targeting antibody-drug conjugate for advanced solid tumors (搜索).
The company advanced KIVU-107 (搜索) from preclinical development to first-in-human dosing in under 12 months, demonstrating platform efficiency.
KIVU-107 (搜索) utilizes GlycoConnect® and HydraSpace® site-specific conjugation technologies to enable precise drug-to-antibody ratios and optimized pharmacokinetics.
Kivu Bioscience (搜索) has achieved a significant milestone by dosing the first patient in its Phase 1 clinical trial of KIVU-107 (搜索), a next-generation PTK7 (搜索)-targeting antibody-drug conjugate (ADC) designed for patients with advanced solid tumors (搜索). The achievement marks a rapid progression from preclinical development to first-in-human dosing in under 12 months.
"Dosing the first patient with KIVU-107 (搜索) marks an important milestone for Kivu and for patients with advanced solid tumors (搜索) who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience (搜索). "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."
Advanced Conjugation Technology Platform
KIVU-107 (搜索) is built using proprietary GlycoConnect® and HydraSpace® site-specific conjugation technologies, which enable precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. The ADC is designed to deliver potent, targeted cytotoxic activity in PTK7 (搜索)-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs.
The drug represents the first PTK7 (搜索)-targeting ADC with a DAR4 exatecan payload, engineered for exceptional stability and highly selective on-tumor delivery. KIVU-107 (搜索) leverages an exatecan payload (SYNtecan E™) with an optimized drug-antibody ratio, designed to be highly stable in circulation with negligible free payload release, maximizing on-tumor activity while minimizing off-target toxicity.
Phase 1 Study Design and Regulatory Approval
The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 (搜索) in patients with advanced solid malignancies (搜索). The study has received regulatory approval in both the United States and Australia.
Compelling Preclinical Data
Preclinical studies demonstrated that KIVU-107 (搜索) showed potent antigen-specific cytotoxicity with rapid internalization in vitro. In mouse xenograft models, durable complete tumor regressions were observed after a single dose. The ADC 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. These findings confirm a wide therapeutic index and best-in-class potential for efficacy, stability, and safety.
"These preclinical data highlight the potential of KIVU-107 (搜索) as a next-generation ADC designed to deliver enhanced efficacy, superior stability, and improved tolerability," said Trikha. "In preclinical studies, KIVU-107 is both highly potent and exceptionally well-tolerated, a combination that's rare among ADCs."
Company Platform and Pipeline
Kivu Bioscience (搜索) is a clinical-stage biotechnology company developing next-generation antibody-drug conjugates for oncology. The company's proprietary linker-payload technologies are designed to improve safety and efficacy by minimizing off-target toxicity. With multiple ADC programs in development and a team of industry veterans, Kivu is advancing innovative therapies for patients with cancer (搜索). The company is headquartered in San Mateo, California.