WILMINGTON, DE — NiKang Therapeutics Inc. announced it has completed dosing in the first patient cohort of its Phase 1 dose-escalation study evaluating NKT5097, an oral small molecule designed to selectively degrade CDK2 and CDK4. The investigational therapy targets hormone receptor-positive (HR+) breast cancer and other tumors driven by cyclin E pathway activation.
The open-label trial (NCT07029399) is assessing safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced or metastatic solid tumors, with a focus on HR+ breast cancer and CCNE1-amplified cancers. The goal is to establish recommended doses for future expansion cohorts.
Early findings indicate that NKT5097 achieves favorable oral exposure and significant suppression of thymidine kinase activity (TKa), a biomarker of cell proliferation. In the initial cohort, breast cancer patients previously treated with CDK4/6 inhibitors showed marked reductions in TKa levels. The compound has been well-tolerated to date.
“We are pleased to achieve this significant milestone expeditiously after IND clearance,” said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. “Due to its superior selectivity against CDK1 and CDK6, NKT5097 has the potential to mitigate neutropenia and diarrhea associated with existing CDK2 or CDK4/6 inhibitors. These early findings underscore the potential of our dual degrader approach.”
NKT5097 is positioned as the first highly selective, oral CDK2/4 dual degrader in clinical development. By targeting two key regulators of the cell cycle, NiKang aims to address resistance mechanisms limiting current CDK4/6 inhibitors and to establish a new treatment option for HR+ breast cancer.
Completion of the first cohort marks a step forward in validating the company’s strategy of applying targeted protein degradation to high-value oncology targets. Expansion cohorts are expected to further define NKT5097’s therapeutic potential across breast cancer and other solid tumors with aberrant CDK2/cyclin E activity.
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