Beyond Air, Inc. (NASDAQ: XAIR) disclosed that its oncology subsidiary, Beyond Cancer, Ltd., has observed encouraging early clinical activity in its Phase 1 ultra‑high‑concentration nitric oxide (UNO) trial. The study enrolled ten heavily pre‑treated patients with solid tumors; as of October 1, 2025, seven of those patients remain alive between 19 and 37 months after a single intratumoral UNO injection, and two triple‑negative breast cancer patients achieved no evidence of disease.
Safety data from the trial were also favorable. Most treatment‑related adverse events were Grade 1, and only one serious adverse event—hypoxia—occurred during a 25,000 ppm dose and resolved fully. Six patients received 25,000 ppm UNO and four received 50,000 ppm, and the median survival in this end‑stage population was 22 months, compared with a typical 12‑month survival for similar patients.
Steve Lisi, CEO of Beyond Air, said the results "strengthen our belief that UNO could serve as a differentiated complement to anti‑PD‑1 therapy in metastatic disease and perhaps as monotherapy prior to metastases." The data suggest that UNO may enhance existing immunotherapies or provide a new treatment option for patients who have exhausted standard options.
Beyond Cancer plans to present an updated analysis of the Phase 1 data at the American Association for Cancer Research (AACR) Annual Meeting, scheduled for April 17‑22, 2026, in San Diego, California.
The early‑stage findings are a promising step for Beyond Cancer’s oncology pipeline, offering a potential new therapeutic avenue that could be combined with or used independently of current anti‑PD‑1 agents. While the trial is small and preliminary, the survival signals and safety profile provide a foundation for further clinical development and may influence the company’s future research priorities and investor expectations.
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