BOSTON — Nimbus Therapeutics announced the completion of dose escalation in the Phase 1/2 clinical trial evaluating NDI-219216, an investigational non-covalent Werner syndrome helicase inhibitor being developed for the treatment of microsatellite instability-high tumors.
The dose escalation portion of the open-label study, known as Part A, showed a favorable safety profile for NDI-219216. Nimbus said no dose-limiting toxicities or severe treatment-related adverse events were observed through the maximum administered dose, and a maximum tolerated dose was not reached. Pharmacokinetic and pharmacodynamic data demonstrated sustained WRN target engagement for more than 24 hours across multiple dose levels.
Nimbus completed dose escalation approximately nine months ahead of schedule, driven by strong patient recruitment and accelerating enrollment across global clinical sites.
“Completing dose escalation represents an important milestone in the clinical development of NDI-219216,” said Anita Scheuber, M.D., Ph.D., senior vice president and therapeutic area head of oncology at Nimbus. “We are encouraged by the favorable safety profile and robust target coverage that is translating into early clinical activity in patients. The accelerated timeline, driven by strong patient recruitment, underscores the significant unmet need in this patient population. These results reinforce our confidence in NDI-219216’s differentiated profile and its potential to address patients with MSI-H tumors who have limited treatment options. We look forward to sharing clinical data at an upcoming scientific conference.”
The Phase 1/2 trial is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of NDI-219216 in patients with advanced solid tumors. The study is being conducted in three stages: Part A for dose escalation, Part B for dose optimization, and Part C for dose expansion.
With Part A complete, Nimbus said the trial is now advancing into Part B, which will focus on identifying the recommended dose or doses for further clinical evaluation.
