On December 11, 2025 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to bring transformative therapies to patients in need, reported the presentation of detailed preclinical data on NKT5097 at the 2025 San Antonio Breast Cancer Symposium (SABCS 2025) being held December 9-12, 2025, in San Antonio, TX. NKT5097 is a first-in-class, orally bioavailable small molecule engineered to selectively degrade CDK2 and CDK4 simultaneously, offering potential therapeutic benefits for patients with HR+ breast cancer and tumors driven by aberrant CDK2/cyclin E pathway activation.

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NiKang has initiated a Phase 1, open-label, dose escalation study of NKT5097 as a single agent. This first-in-human study (NCT07029399) is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of NKT5097 in patients with advanced or metastatic solid tumors, with a focus on breast cancer and tumors with CCNE1 amplification.

"We are excited to share these compelling preclinical data for NKT5097 at this year’s SABCS," said Zhenhai Gao, Ph.D., co-founder, president and CEO of NiKang. "Our research has centered on designing a molecule that selectively degrades CDK2 and CDK4 while sparing CDK1, CDK6, CDK7, and CDK9, with the goal of significantly reducing the gastrointestinal and hematologic toxicities associated with currently approved CDK4/6 inhibitors and addressing emerging resistance mechanism. NKT5097 represents the first compound from our industry-leading CDK2/4 degrader portfolio. Its unique ability to simultaneously degrade both CDK2 and CDK4 offers a promising therapeutic strategy that may deliver deeper and more durable clinical benefits for patients."

Poster Presentation Details:

Title:

Discovery of NKT5097: a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader for cancer therapy

Presenter:

Ke Liu

Abstract Number:

847

Presentation Number:

PS4-04-30

Date and Time:

Thursday, December 11, 2025, 5:00 PM – 6:30 PM

About NKT5097

NKT5097 is a first-in-class, highly potent and selective, orally bioavailable CDK2/4 dual degrader, designed to achieve sustained inhibition of the CDK2 and CDK4 pathway. By maximizing selective suppression of these pathways, NKT5097 has the potential to harness the full therapeutic benefits of CDK2 and CDK4 inhibition. NKT5097 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT07029399).

(Press release, NiKang Therapeutics, DEC 11, 2025, View Source [SID1234661388])