On October 16, 2023 Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, reported promising new preclinical data further supporting the company’s novel UNO therapy for various types of solid tumors as a single agent and in combination with checkpoint inhibitors (Press release, MediGene, OCT 16, 2023, View Source [SID1234636022]). These data were presented in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) (Free AACR-NCI-EORTC Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2023, which was held October 11th – 15th in Boston, Massachusetts. Full abstracts and posters are available on the company’s website (click here).
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"With today’s data we continue to further elucidate the mechanism by which UNO demonstrates synergy with checkpoint inhibitors," stated Dr. Selena Chaisson, Chief Executive Officer and Director of Beyond Cancer. "We further quantified the extent of the synergy seen with the combination of UNO and checkpoint inhibitors by using a meta-analysis of the data in a large body of work. Data from this analysis are exciting additions to the growing body of evidence supporting UNO as a potential therapeutic option for cancer patients. We look forward to the initial data from our first-in-human Phase 1a study later this year."
Abstract #: 35782 describes a pooled analysis of preclinical studies utilizing 50,000 or 100,000 ppm UNO for 5 or 10 minutes in combination with 4-5 doses of 5 or 10 mg/kg Anti-mPD-1. The analysis showed that the combination therapy resulted in statistically significant primary and secondary tumor-free mice at day 75 compared with mice treated with anti-mPD-1 alone (p=0.02). In addition, the analysis showed a statistically significant improvement in survival during the same time period (p=0.0038).
Abstract #: 35688 represented an ex vivo analysis of T-cell response following administration of a 5-minute treatment of 50,000 or 100,000 ppm UNO in combination with 2-5 doses of 5 or 10 mg/kg Anti-CTLA-4. At day 5, mice treated with the combination therapy showed a statistically significant increase in the expression of proliferating T-helper cells versus mice treated with anti-mCTLA-4 alone. Mice treated with the combination therapy also demonstrated increases in cytotoxic T-cells, as well as a significant increase in active T-helper cells as represented by IFNƔ responses. At day 7, mice treated with either UNO alone or in combination with Anti-mCTLA-4 had significant increases in the expression of central memory T-cells. Further, at day 55, in cured mice treated with the combination therapy, the expression of the antigen specific T-cells was nearly statistically significant relative to untreated mice. A separate experiment carried out to day 100, demonstrated a statistically significant expression of antigen specific cytotoxic T-cells relative to naïve mice.
"This pooled analysis involving a significant number of mice across multiple experiments strengthens support for ongoing and future studies of UNO alone and in combination with immunotherapy for the treatment of solid tumors," stated Dr. Frederick Dirbas, Chair of the Beyond Cancer Scientific Advisory Board.
Details of the company’s poster presentations are as follows:
Title: Intratumoral Administration of Ultra High-Concentration Nitric Oxide (UNO) and Anti PD-1 Treatment Leads to High Tumor Regression Rates and Prolonged Survival in Tumor-Bearing Mice
Poster number: A078
Session: Poster Session A
Session Date and Time: Thursday, October 12, 2023 / 12:30 pm – 4:00 pm EDT
Session Location: Level 2, Exhibit Hall D
Abstract Number: 35782
Participant: Yana Epshtein, PhD; Head of Translational Science, Beyond Cancer, Ltd.
Title: Ultra-high concentration nitric oxide (UNO) enhances anti-CTLA-4 treatment activity and induces a durable anti-tumor response
Poster number: C080
Session: Poster Session C
Session Date and Time: Saturday, October 14, 2023 / 12:30 pm – 4:00 pm EDT
Session Location: Level 2, Exhibit Hall D
Abstract Number: 35688
Participant: Yogev Sela, PhD; Head of In Vitro Studies, Beyond Cancer, Ltd.
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.