NeOnc Technologies disclosed that 24 % of 25 patients with recurrent WHO Grade III/IV IDH1‑mutant astrocytoma achieved significant radiographic remission, 44 % reached six‑month progression‑free survival, and 36 % remain alive 18 months or longer after starting treatment. No significant toxicity was observed during chronic dosing.
The 24 % response rate represents a three‑fold increase over the typical 8 % seen with salvage therapies in this patient population, while the 44 % PFS‑6 exceeds historical benchmarks of 21–31 %. The 36 % 18‑month survival rate further underscores the durability of the clinical signal and suggests that intranasal delivery of perillyl alcohol can achieve meaningful disease control in a heavily pre‑treated glioma cohort.
NEO100’s intranasal formulation delivers perillyl alcohol directly to the central nervous system, bypassing the blood‑brain barrier and positioning the drug as a first‑in‑class CNS‑penetrant metabolic therapy. The absence of chronic toxicity supports the feasibility of long‑term dosing, a critical factor for a disease with limited treatment options.
While the data strengthen NEO100’s clinical profile, NeOnc remains a clinical‑stage company with a net loss and accumulated deficit that will require additional financing. The results are expected to influence regulatory discussions and the company’s Phase II readout timeline, but investors are likely to weigh the financial headwinds and the need for future capital when assessing the company’s prospects.
Executive Chairman, President and CEO Amir F. Heshmatpour said, “The addition of another patient achieving both long‑term survival and radiographic remission further validates what we believe is a highly compelling and differentiated therapeutic signal. With radiographic responses now 300 % higher than the rate historically reported with salvage therapies, these updated data reinforce our conviction that NEO100 may represent a meaningful advance for patients with recurrent IDH1‑mutant high‑grade gliomas.”
Investors have responded cautiously, focusing on valuation and the company’s financial position. The market reaction has been muted, reflecting concerns about NeOnc’s need for future financing and the early‑stage nature of the data.
The updated results provide a stronger clinical foundation for NEO100, but the company must secure additional capital and navigate the regulatory pathway to translate this signal into a viable product. The data are a positive milestone, yet they underscore the challenges that remain before the therapy can reach patients and generate revenue.
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