Beyond Air (NASDAQ:XAIR) Announces Approval for Phase 1b Clinical Trial of LV UNO with Anti-PD-1 Therapy

On December 3, 2024, Beyond Air, Inc. reported a significant development involving its majority-owned affiliate, Beyond Cancer, Ltd. The Israeli Ministry of Health has given its approval for the use of Low Volume UNO (LV UNO) in a Phase 1b clinical trial in combination with anti-PD-1 therapy.

The Phase 1b study conducted by Beyond Cancer, Ltd. will focus on evaluating LV UNO in patients with unresectable cutaneous or subcutaneous primary or metastatic solid tumor cancers. These patients have either progressed or maintained prolonged stable disease on single-agent PD-1 inhibitors. The primary goal of this trial is to measure the preliminary efficacy through objective response rate (ORR) and duration of response (DOR) based on RECIST version 1.1 guidelines, along with assessing immune-related responses using iRECIST criteria. Patient recruitment is set to commence in early 2025 across four different sites in Israel.

Steven A. Lisi, the Chief Executive Officer of Beyond Air, expressed enthusiasm about the Phase 1b trial, considering LV UNO as a potential game-changer in solid tumor treatment when used alongside PD-1 inhibitors. Dr. Jedidiah Monson, Chief Medical Officer of Beyond Cancer, emphasized the promising outcomes of preclinical studies, where UNO exhibited increased PD-L1 expression and enhanced overall survival compared to anti-PD-1 treatment alone.

Dr. Selena Chaisson, CEO, and Director of Beyond Cancer highlighted the initiation of the Phase 1b trial as a crucial step in advancing personalized cancer care. She sees UNO as a promising adjunct therapy for future cancer treatments, especially for individuals with anti-PD-1 refractory or resistant conditions, possibly offering broader access to effective treatment options.

Beyond Cancer aims to use ultra-high concentration nitric oxide (UNO) through a proprietary delivery system to treat primary tumors and prevent metastases. This innovative approach seeks to minimize relapse or metastatic disease with potentially limited toxicity or off-target effects through as little as a single 5-minute treatment.

The approval of the Phase 1b trial heralds a step forward in the quest for advanced cancer therapy strategies. Beyond Air and Beyond Cancer’s initiatives to utilize nitric oxide for treating solid tumors could pave the way for improved outcomes in cancer treatment paradigms worldwide.

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This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Beyond Air’s 8K filing here.

About Beyond Air

Beyond Air, Inc operates as a commercial-stage medical device and biopharmaceutical company in the United States. The company engages in the development of LungFit platform, a nitric oxide generator and delivery system. It offers LungFit PH for the treatment of persistent pulmonary hypertension of the newborn.