NeOnc Technologies announced topline results from the Phase 2a portion of NEO100-01, an open-label study of intranasal NEO100 in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint. Six-month progression-free survival was 48.9% by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care. Secondary survival endpoints were supportive. Median overall survival was 26.09 months, with 12 deaths among 24 patients. Overall survival was 86.7% at six months, 60.9% at 12 months and 54.1% at 24 months. Evidence of durable disease control was observed across the cohort. Five of 24 patients remain on active treatment. One patient has remained progression-free for approximately 19 months. A second patient achieved a partial response sustained for 114 days through the end of Cycle 8 and remains on treatment in response. Objective response rate was 8.3% by RANO 2.0. The data suggests that NEO100 was well tolerated. No major toxicities were reported across the cohort, and adverse events to date have been predominantly low-grade. The tolerability profile is consistent with the Phase 1 portion of the study, in which the data suggested that NEO100 was well tolerated at all dose levels, with no severe or dose-limiting toxicities observed. The absence of significant toxicity is notable in a population receiving continuous therapy and reflects a delivery route designed to reach the brain without systemic cytotoxic exposure. NEO100-01 is directed at a population that existing IDH-targeted therapies do not serve. Approved and late-stage IDH-targeted agents for glioma have been developed in the front-line setting for lower-grade disease, typically Grade 2, non-enhancing tumors in patients who have undergone surgery but have not yet received radiation or chemotherapy. NEO100-01 enrolled the opposite population: patients with Grade III and Grade IV IDH1-mutant tumors that have recurred or progressed after radiation and temozolomide. There is no approved targeted therapy for these patients. Approximately 90% of high-grade glioma patients recur within six to nine months of maximal therapy, and at recurrence, surgery is often not repeatable and systemic agents face rapid resistance and cumulative toxicity. NEO100 is administered intranasally by the patient at home, four times daily, in 28-day cycles, a delivery route designed to reach the brain directly while avoiding systemic cytotoxic exposure. NeOnc intends to request a Type B meeting with the U.S. Food and Drug Administration to align on a registrational development path for NEO100 in recurrent IDH1-mutant high-grade glioma. Additional pre-specified analyses including the Grade III versus Grade IV subgroup analysis, pharmacokinetics, and quality-of-life measures are ongoing and will be reported separately. The Company expects to present the full Phase 2a dataset, including detailed safety, at a future medical meeting.

6/15 16:30

NeOnc Technologies Files to Sell 555,554 Shares of Common Stock

NeOnc Technologies files to sell 555,554 shares of common stock for holders

4/10 17:20

NeOnc Technologies Files to Sell 680,558 Shares of Common Stock

NeOnc Technologies files to sell 680,558 shares of common stock for holders

4/10 16:50

Company Signs $75M Equity Distribution Agreement with BTIG

On April 10, the company entered into an Equity Distribution Agreement with BTIG and A.G.P./Alliance Global Partners to create an "at the market" equity program under which it may sell up to an aggregate of $75M of shares of the company's common stock from time to time through or to the placement agents.

4/2 13:10

NeOnc Technologies Files $300M Mixed Securities Shelf

NeOnc Technologies files $300M mixed securities shelf

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