NeOnc Sets 610 mg Phase 2 Dose After Reaching 810 mg MTD with NEO212
NeOnc reached Maximum Tolerated Dose at 810 mg for oral NEO212 and set the Recommended Phase 2 Dose at 610 mg, with the Phase 2a metastasis cohort starting at 400 mg. Early efficacy signals included durable disease control in heavily pretreated recurrent glioblastoma and brain metastases patients.
1. Dose-Escalation Results and RP2D Determination
NeOnc notified FDA that the Phase 1 dose-escalation portion reached MTD at Cohort 5 (810 mg, Days 1–5 of a 28-day cycle) after a second dose-limiting toxicity, halting escalation. The Recommended Phase 2 Dose was set at 610 mg (Cohort 4), with the Phase 2a metastasis cohort to start at 400 mg.
2. Early Clinical Efficacy Signals
Despite its safety focus, the study observed promising signs of clinical efficacy, including indications of lasting disease control in heavily pretreated patients with recurrent glioblastoma and brain metastases across dose-escalation cohorts.
3. Regulatory and Development Plans
NeOnc intends to request a Type B FDA meeting to review safety, PK/PD, preliminary efficacy, RP2D justification and Phase 2 design, pursuing potential accelerated approval pathways for NEO212 as it transitions into Phase 2.
4. NEO212 Mechanism and Platform Significance
NEO212 is the first oral bio-conjugated temozolomide, designed to overcome MGMT-mediated resistance by promoting MGMT degradation and enhancing blood–brain barrier penetration, validating NeOnc’s drug-engineering capabilities and supporting its CNS therapy platform.