On April 15, 2024 NiKang Therapeutics Inc. ("NiKang"), a clinical stage biotech company focused on developing innovative small molecule oncology medicines to help patients with unmet medical needs, reported that the first patient has been dosed in a phase 1/1b, open-label, first-in-human dose escalation and expansion study of single agent NKT3447, a small molecule that inhibits cyclin-dependent kinase 2 (CDK2) (Press release, NiKang Therapeutics, APR 15, 2024, View Source [SID1234642079]). NKT3447 is designed to treat patients with cancers driven by cyclin E amplification or overexpression, which is present in many different tumor types.
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The Phase 1/1b trial (NCT06264921) is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of NKT3447 in adult patients with advanced or metastatic solid tumors driven by cyclin E or CDK2.
"The initiation of dosing in this study marks a major milestone for NiKang, as NKT3447 is the first of our pipeline programs targeting the cell cycle to begin clinical evaluation," said Zhenhai Gao, Ph.D., co-founder, president, and CEO of NiKang. "We have strong conviction that CDK2 is a key oncology target and have taken a holistic approach to build an industry-leading portfolio that also includes a CDK2-selective degrader and a CDK2/4 dual degrader. While there has been clinical success with drugs targeting the cell cycle, it has been challenging to identify inhibitors of CDK2 that spare CDK1 and do not cause a compensatory increase of cyclin E which is a driver of tumor cell proliferation. NKT3447 binds inactive monomeric CDK2, disrupting the CDK2/cyclin E complex without impacting CDK1. Furthermore, its interaction with CDK2 results in suppression of activating phosphorylation of CDK2 on Thr160 and a substantial downregulation of cyclin E, potentially preventing a mechanism of resistance."
"We are excited to initiate clinical trials of NKT3447, which has unique features that have led to sustained pharmacodynamic effects and significant anti-tumor activity in various cyclin E amplified tumor models," said Joanne Jenkins Lager, M.D., Chief Medical Officer of NiKang. "CDK2 and cyclin E are deregulated in many human cancers, and we believe NKT3447 has the potential to change the standard of care for people with cyclin E amplified or overexpressing cancers including ovarian cancer, endometrial cancer and gastric cancer."