- NKT3964, a first-in-class, highly potent and selective oral CDK2 degrader, is designed to treat patients with cyclin E driven cancers -
- Initial pharmacokinetic (PK) and pharmacodynamic (PD) data suggest good exposure and desirable CDK2 degradation in patients -
WILMINGTON, Del.--(BUSINESS WIRE)--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, announced today the successful completion of dosing the first cohort of patients in its Phase 1 dose escalation study of NKT3964 as a single agent. NKT3964 is a first-in-class, orally bioavailable small molecule that selectively degrades CDK2. NKT3964, with high potency, selectivity and sustained inhibition of the CDK2 pathway without cyclin E accumulation, has the potential to provide therapeutic benefits for patients with aberrant CDK2/cyclin E pathway activation, such as ovarian, endometrial, gastric and HR+HER2- breast cancers.
The Phase 1 trial (NCT06586957) is an open-label, dose escalation study designed to evaluate safety, tolerability, PK, PD and preliminary anti-tumor activity to determine the recommended dose(s) for expansion of NKT3964 monotherapy in adults with advanced or metastatic solid tumors.
“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. “Completing dosing in our first cohort brings us one step closer to understanding the potential of this groundbreaking CDK2 degrader, one of several molecules in our portfolio targeting the cell cycle. Initial PK data from the first cohort demonstrated good oral exposure that aligns with human PK projections. Additionally, NKT3964 has achieved CDK2 degradation levels in patients that are consistent with those observed in preclinical in vivo studies. These early observations are particularly encouraging as they address the considerable challenges of achieving oral bioavailability with a PROTAC degrader. These findings will help guide dose optimization as the trial advances. Our pipeline focused on cell cycle inhibition via CDK2 degradation or CDK2/CDK4 dual degradation enables us to have multiple opportunities for success. We are excited by this progress and remain committed to advancing transformative therapies to help patients fight cancer and live better lives.”
About NKT3964
NKT3964 is a first-in-class, highly potent and selective, orally bioavailable CDK2 degrader, causing prolonged CDK2 pathway inhibition without cyclin E accumulation. It has the potential to maximally and selectively suppress the CDK2 pathway, thereby harnessing the full therapeutic benefits of CDK2 inhibition. NKT3964 is currently under evaluation in a Phase 1 clinical study in advanced or metastatic solid tumors as a single agent (NCT06586957).
About NiKang Therapeutics
NiKang Therapeutics is a clinical-stage biotech company focused on discovering and developing innovative small molecule oncology medicines to bring transformative therapies to patients in need. Our target selection is driven by deep insight into disease biology and molecular pathways. Our discovery approach is informed by target structure biology and capitalizes on structure-based drug design. The successful implementation of our strategy enables us to rapidly and efficiently discover and advance proprietary drug candidates with the most desirable pharmacological features into clinical studies. We have successfully advanced three programs into clinical trials, including NKT2152 (HIF2α), NKT3447 (CDK2), and NKT3964 (CDK2).
For more information, please visit http://www.nikangtx.com
Contacts
Kelsey Chen
Chief Financial and Operating Officer
IR@nikangtx.com
