On December 27, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities (Press release, Beyond Air, DEC 27, 2023, View Source [SID1234638837]).
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The first-in-human, open-label, non-randomized Phase 1 study is being conducted in two parts: Dose Escalation and Dose Expansion. The Dose Escalation consists of three UNO cohorts (25,000, 50,000 and 100,000 ppm) of three to six patients. The Dose Expansion will begin once the recommended dose is determined in the Dose Escalation portion. The primary objective of the trial is to assess the safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to UNO therapy.
"We are delighted to advance to the next cohort of our Phase 1 trial with no reported dose limiting toxicities," said Dr. Jedidiah Monson, Beyond Cancer’s Chief Medical Officer. "The well tolerated administration of UNO is encouraging and the feasibility of UNO administration in patients has been demonstrated. We look forward to completing Dose Escalation, advancing the UNO development program to the Dose Expansion portion of the study, and future combinations with immune checkpoint inhibitors. We expect to build upon the positive initial preliminary efficacy data presented at this year’s SITC (Free SITC Whitepaper) annual meeting demonstrating evidence of immune system activation with further updates at major medical conferences in 2024."
Additional information about this trial is available at clinicaltrials.gov (NCT#05351502).
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.