XAIR - Beyond Cancer™ Presents Positive First-in-Human Clinical Data for Ultra-High Concentration Nitric Oxide (UNO) Therapy in Solid Tumors During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting | Benzinga
First-in-human Phase 1 study demonstrates early clinical proof of concept
Positive clinical biomarker data demonstrate evidence of immune system activation and the translation of the immunogenic response previously observed in preclinical studies
Data represent the first successful administration of intratumoral UNO therapy
Additional Phase 1 data for UNO expected in 2024
GARDEN CITY, N.Y. and HAMILTON, Bermuda, Nov. 03, 2023 (GLOBE NEWSWIRE) -- 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, today announced encouraging first-in-human and first-in-class clinical data demonstrating a promising safety profile and clear evidence of immune system activation via biomarker response. The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of ultra-high concentration nitric oxide as an immunotherapeutic. These data were presented today at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2023, which is being held in San Diego, California from November 1st to 5th via a poster presentation of abstract number 733.
"The development of immunotherapy has pushed the frontier of cancer medicine further than ever expected," stated Dr. Jedidiah Monson, Chief Medical Officer. "Beyond Cancer is thrilled to contribute to this rapidly evolving landscape with a straightforward, minimally invasive procedure that may very well become a part of the immunotherapeutic armamentarium."
The Company's abstract presented at SITC includes safety, tolerability, biomarker and initial antitumor activity results from 5 subjects dosed with 25,000 ppm UNO. The data show UNO at 25,000 ppm delivered over 5-minutes upregulates cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulating T-regulatory cells and mononuclear-myeloid-derived suppressor cells (M-MDSC).
Specifically, by Day 21, a single UNO administration resulted in an immunostimulatory effect. Dendritic cells increased more than 250%, representing more than a 2-fold increase in the magnitude observed in a murine model utilizing 50,000 ppm UNO. In addition, more than a 150% increase in T-central memory cells was observed, consistent with previously reported murine data (Sela Y et al. AACR/NCI/EORTC 2023). Encouragingly, there was also a greater than 50% increase in M1 macrophages over the same time period.
UNO also had a favorable impact on the inhibitory cells of the immune system. T-regulatory cells decreased by 40% by Day 21 and myeloid derived suppressor cells (M-MDSC) decreased by greater than 30% by Day 7.
Dr. Frederick Dirbas, Head of the Beyond Cancer Scientific Advisory Board, commented, "Prior preclinical data convincingly demonstrated immunostimulatory and anti-tumor effects of UNO compared to control in mice. To see the same immunostimulatory effects from preclinical studies carry over to humans is an important milestone in assessing the potential anti-tumor effects of UNO in humans."
Of the five heavily pre-treated patients treated as of this data cut, UNO was well tolerated with primarily Grade 1 related toxicities ...