Story
NeOnc Technologies Shares Surge on Positive Phase 2 Glioma Trial Data
Summary
NeOnc Technologies Holdings (NASDAQ:NTHI) reported that its drug NEO100 met its primary endpoint in a Phase 2a study for recurrent high-grade glioma, causing the company's stock to rise sharply.
Shares of NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) surged after the company announced positive topline results from its Phase 2a clinical trial of NEO100 in patients with a recurrent form of brain cancer. The company's stock rose 11.7% following the news.
Key Trial Results
The study, which evaluated intranasal NEO100 in patients with recurrent IDH1-mutant high-grade glioma, successfully met its primary endpoint. The trial demonstrated a six-month progression-free survival (PFS) rate of 48.9%, significantly higher than the pre-specified benchmark of 20% for standard of care, with a p-value of 0.0047.
The trial enrolled 24 patients with Grade III and Grade IV tumors that had progressed after initial treatment. According to NeOnc, key secondary and other endpoints included:
- Median overall survival reached 26.09 months.
- 86.7% of patients were alive at the six-month mark.
- The objective response rate was 8.3%, with two patients achieving a response.
Safety Profile and Next Steps
AdThe company reported that NEO100, which is self-administered by patients at home four times daily, was well-tolerated. No major toxicities were observed, and adverse events were described as predominantly low-grade. Five patients from the study remain on active treatment.
NeOnc Technologies plans to request a Type B meeting with the U.S. Food and Drug Administration (FDA) to discuss a registrational development path for NEO100. This is a critical step toward potential market approval. The company noted that there are currently no approved targeted therapies for this specific patient population—recurrent IDH1-mutant high-grade glioma.
Market Context
This indication represents a significant unmet medical need. While other IDH-targeted agents have been approved, they are for lower-grade disease in the front-line setting, not for patients with recurrent high-grade tumors like those in the NEO100 trial.
NeOnc stated it expects to present the full dataset from the Phase 2a study, including detailed safety and pharmacokinetic data, at a future medical conference. Further analyses are currently ongoing.
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