Beyond Cancer Reports Early Clinical Activity and Favorable Safety Profile with Interim Data from Phase 1 UNO Trial

Core Insights - Beyond Cancer, Ltd. has reported early signs of clinical activity and a favorable safety profile for its investigational immunotherapeutic, ultra-high concentration nitric oxide (UNO), in a Phase 1 clinical trial for solid tumors [1][4] Group 1: Clinical Trial Details - The Phase 1 trial (NCT05351502) involved ten heavily pretreated patients with unresectable cutaneous or subcutaneous lesions, including breast cancer (6 patients), squamous cell carcinoma (2 patients), and melanoma (2 patients) [2] - Patients had a mean of 5.5 prior systemic therapies and 10.3 total cancer-directed treatments, with six patients receiving 25,000 ppm UNO and four patients receiving 50,000 ppm UNO [2] Group 2: Patient Outcomes - As of October 1, 2025, seven out of ten patients remained alive between 19 to 37 months post-treatment, with one patient dying from disease progression 25 months after treatment [3] - Two patients with triple-negative breast cancer showed no evidence of disease, and no deaths occurred within 12 weeks after treatment [3] Group 3: Safety and Tolerability - The treatment demonstrated a favorable safety and tolerability profile, with most treatment-related adverse events classified as Grade 1; one serious adverse event (hypoxia) occurred but was not dose-limiting and resolved fully [3] Group 4: Future Directions - The CEO of Beyond Air expressed optimism that UNO could complement anti-PD-1 therapy in metastatic disease and potentially serve as a monotherapy prior to metastases, highlighting the compelling survival duration in this heavily pre-treated population [4] Group 5: Upcoming Presentation - Data from the ongoing Phase 1 trial will be presented at the AACR Annual Meeting 2026 on April 19, 2026, in San Diego, California, with an updated analysis beyond the published abstract [5]