On April 20, 2026 Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an investigational immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), reported updated follow-up data from its Phase 1 UNO trial, which are being presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 in San Diego, California.
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The Phase 1 trial (NCT05351502) was a clinical proof-of-concept trial that assessed the intratumoral administration of UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions. The trial enrolled ten heavily pretreated patients, including breast cancer (n=6), squamous cell carcinoma (n=2), and melanoma (n=2). Patients received a median of 4 prior systemic therapies and 11 total cancer-directed treatments. Six patients received 25,000 ppm UNO and four patients received 50,000 ppm UNO.
As of February 2, 2026, six of ten patients remain alive between 22 to 40 months following a single UNO injection. While the study was not designed to assess efficacy and lacks a control arm, these observations may suggest prolonged survival in this heavily pretreated population. Interpretation of these results is limited by the small sample size and early-stage design. Two patients with triple negative breast cancer continue to demonstrate no evidence of disease, based on available imaging, testing, and clinical examinations. Treatment demonstrated a generally favorable safety and tolerability profile, with most treatment related adverse events predominantly Grade 1 or Grade 2. One treatment-related serious adverse event (hypoxia) occurred during administration at 25,000 ppm; the event was not considered dose-limiting and resolved fully. Median overall survival had not yet been reached at last follow-up because more than 50% of patients remain alive at last follow up.
"We are pleased to present these updated and promising data from the UNO study at AACR (Free AACR Whitepaper)," said Robert Goodman, Chief Executive Officer of Beyond Air. "What stands out is not only the durability of survival, but the context in which it is occurring. These observations are notable in a salvage stage population with few therapeutic alternatives, where enrolled patients had exhausted standard treatment options and received a median of four prior systemic therapies. Observing prolonged survival following a single localized UNO injection reinforces our conviction that UNO has meaningful therapeutic potential and supports further development, including evaluation in combination with immune checkpoint inhibitors and in earlier lines of disease."
In addition, the company announced that the U.S. Patent and Trademark Office issued a Notice of Allowance for a patent application titled, "System and Method for Delivery of Gas to a Tissue." Once issued, the patent will further strengthen the company’s intellectual property portfolio supporting its UNO platform.
About Nitric Oxide
Nitric Oxide (NO) is a potent molecule, naturally synthesized in the human body, proven to play a critical role in a broad array of biological functions. In the airways, NO targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs. Currently, exogenous inhaled NO is used in adult respiratory distress syndrome, post certain cardiac surgeries and persistent pulmonary hypertension of the newborn to treat hypoxemia. Additionally, NO is believed to play a key role in the innate immune system and in vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, including both gram-positive and gram-negative, but also against other diverse pathogens.
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to contribute to anti-tumor immune responses and may be explored for its role in preventing relapse or metastatic disease in future studies, including evaluation of dosing and treatment duration, and with limited toxicity or off-target effects.
(Press release, Beyond Cancer, APR 20, 2026, View Source [SID1234664558])