WILMINGTON, DE — NiKang Therapeutics® Inc. has achieved a pivotal step in the development of its first-in-class CDK2 degrader, NKT3964, by completing the dosing of the first patient cohort in a Phase 1 dose-escalation study. Designed to target cyclin E-driven cancers, NKT3964 is an oral small molecule offering substantial promise for addressing a subset of aggressive cancers, including ovarian, endometrial, gastric, and HR+HER2- breast cancers.
NKT3964 stands out as a highly potent and selective CDK2 degrader that inhibits the CDK2 pathway while effectively avoiding cyclin E accumulation, a key benefit that enhances its therapeutic potential. Early pharmacokinetic (PK) and pharmacodynamic (PD) data from the trial indicate promising results, with the molecule demonstrating good oral exposure and achieving CDK2 degradation levels consistent with preclinical in vivo findings.
“We are thrilled to reach this milestone in the clinical development of NKT3964,” said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. “Initial data from the first cohort showed good oral bioavailability and aligned closely with our human PK projections. These findings reinforce our confidence in overcoming the challenges typically associated with oral PROTAC degraders and pave the way for optimizing the dose as we move forward. This progress underscores the potential for NKT3964 to transform cancer treatment while addressing unmet needs for patients.”
The Phase 1 clinical trial (NCT06586957) is an open-label study designed to evaluate the safety, tolerability, and early anti-tumor activity of NKT3964. Enrolled participants include adults with advanced or metastatic solid tumors, many of whom require novel therapeutic approaches due to limited existing treatment options.
NKT3964’s innovative mechanism distinctively targets aberrant CDK2/cyclin E pathway activation, a common driver in certain cancers. By maintaining prolonged inhibition of the CDK2 pathway, the therapy may deliver more consistent and effective outcomes compared to existing treatments.
Aligned with its commitment to cell cycle-focused innovation, NiKang is building a portfolio of therapies addressing challenging cancer pathways, including dual CDK2/CDK4 inhibitors. The company remains steadfast in advancing projects like NKT3964 toward improving outcomes for patients battling advanced stages of cancer.
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