ultra-high concentration nitric oxide (UNO101) / Beyond Air - LARVOL DELTA

Beyond Air Reports Fiscal First Quarter 2026 Financial Results and Provides Corporate Update (GlobeNewswire) - "Part A of the trial evaluating UNO therapy in subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed. Phase 1b trial (combination therapy) - Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO)..."

Trial status • Solid Tumor

Beyond Air Granted U.S. Patent Covering Treatment of NTM Infections Using gaseous Nitric Oxide (gNO) (GlobeNewswire) - "Beyond Air...announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 12,274,830. The issued patent gives the Company protection for its method of delivering gaseous nitric oxide (gNO) to a patient that has a condition associated with non-tuberculous mycobacteria (NTM) lung infection....The allowed claims in this patent encompass a novel dosing regimen of 200 ppm to 320 ppm gNO for 10 to 45 minutes, 2 to 5 times per day, to provide a nitric oxide-load (NO load) of 300 ppm-hrs to 900 ppm-hrs of gNO per day over a period of at least 14 days. The patent will expire on March 12, 2038."

Patent • Infectious Disease • Nontuberculous Mycobacterial Disease • Respiratory Diseases

Beyond Air Reports Fiscal Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Beyond Cancer - Solid Tumor Program:...Phase 1b trial (combination therapy) - Received regulatory approval in Israel for Part B of the trial, which will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment. Topline data from the Phase 1b portion of the study are anticipated late in calendar 2025 or early-2026."

P1 data • Trial status • Solid Tumor

Beyond Cancer Announces Approval by the Israeli Ministry of Health to Conduct a Phase 1b Clinical Trial Utilizing Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in Combination with Anti-PD-1 Therapy (GlobeNewswire) - "The trial will be conducted at four sites in Israel and patient screening will begin in the first quarter of 2025. The Phase 1b trial (NCT05351502) is a clinical proof-of-concept trial that will assess the intratumoral administration of LV UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (≥ 12 weeks) after receiving a single agent anti-PD-1 containing treatment. The trial, which is expected to enroll up to 20 subjects, is designed to assess the preliminary efficacy of LV UNO by objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 and secondarily immune-related response via iRECIST."

Trial status • Solid Tumor

Intratumoral administration of low volume ultra-high concentration nitric oxide (UNO201) and anti PD-L1 treatment leads to prolonged survival in MAT B III tumor-bearing rats (SITC 2024) - "Ethics Approval All in vivo experimental procedures will be carried out in accordance with the protocol approved by the Invivotek Ethics Committee on the Use and Care of Animals. Institutional Animal Care and Use Committee (IACUC) approval number: 22-4M.22, 26M.22."

Preclinical • Oncology

Beyond Air Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upon clearance from regulators in Israel, expected shortly, a Phase 1b trial is planned to enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination."

New P1 trial • Solid Tumor

Beyond Cancer Presents Promising Preclinical Data on Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) Therapy at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Data presented in abstract #: 724...showed a greater reduction in primary tumor volume in mice receiving LV UNO in combination with anti-mPD-1 (n=25) at Day 11, compared to mice receiving HV UNO administration with anti-mPD-1 (n=14). Both combination treatment arms (HV UNO and LV UNO with anti-mPD-1) resulted in better tumor reduction than anti-mPD-1 alone (n=16)....HV UNO administration revealed Grade 1 staining, defined as a few positive cells [< 5 cells] versus Grade 3 staining, defined as a mild reaction [15–25 cells] for LV UNO administration (p < 0.01 compared to sham, ANOVA and Tukey HSD statistical methods). Tumors treated with sham or nitrogen showed the lowest levels of nitro-tyrosine staining."

Preclinical • Oncology • Solid Tumor

Beyond Cancer to Present Preclinical Data of Ultra-High Concentration Nitric Oxide (UNO) Low Volume Therapy at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting (GlobeNewswire) - "Beyond Cancer, Ltd...announced being selected to present two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024, which is scheduled to be held November 6–10 at the George R. Brown Convention Center in Houston, Texas. Abstracts are scheduled to be released to SITC registrants on November 5, 2024, 9:00 AM U.S. ET....Presentations of Beyond Cancer’s two full posters will take place on November 8th and 9th at the SITC Annual Meeting; ePublications of the posters will be available November 7th; Therapeutic efficacy of Low Volume (<1L) UNO demonstrated in both mice and rat tumor models."

Preclinical • Oncology • Solid Tumor

A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Beyond Air Inc. | Trial completion date: Apr 2025 ➔ Jun 2025 | Trial primary completion date: Jul 2024 ➔ May 2025

Metastases • Trial completion date • Trial primary completion date • Oncology

Beyond Air Reports Fiscal Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Beyond Cancer - Solid Tumor Program:...Upon regulatory approval, a Phase 1b trial will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with UNO + anti-PD-1 combination upon completion of the Phase 1a trial prior to the end of this year."

New P1 trial • Solid Tumor

Beyond Cancer Presents First-in-Class Clinical Data Showing an Immunogenic Response in Subjects with r/r Unresectable Solid Tumors Treated with Ultra-High Concentration Nitric Oxide (UNO) (GlobeNewswire) - P1b | N=38 | NCT05351502 | Sponsor: Beyond Air Inc. | "Beyond Cancer, Ltd...announced encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population in the ongoing Phase 1a trial....The immune biomarker data at Day 21, following a single 5 minute dose of UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic T-cells, central memory T-cells and a favorable increase in the M1/M2 ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed a 54% decrease. In the 25,000 ppm cohort, the same stimulatory immune biomarkers were upregulated....The Phase 1b trial has been submitted to the Israeli Ministry of Health (IMOH) and upon regulatory approval will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence..."

Biomarker • P1 data • Trial status • Oncology

Beyond Cancer Selected to Present on the Clinical Development of Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2024 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "Beyond Cancer, Ltd...today announced being selected to present on the clinical development program of its Ultra-High Concentration Nitric Oxide (UNO) at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 31 – June 4, 2024 at the McCormick Place Convention Center in Chicago, Illinois. In addition, the Company will host a KOL event that will highlight the ongoing clinical development of UNO (additional details below)."

Clinical data • Oncology • Solid Tumor

A Study to Assess the Safety and Efficacy of Nitric Oxide Injection Into Unresectable Solid Primary or Metastatic Tumors (clinicaltrials.gov) - P1 | N=38 | Recruiting | Sponsor: Beyond Air Inc. | Trial completion date: Jul 2024 ➔ Apr 2025 | Trial primary completion date: Dec 2023 ➔ Jul 2024

Metastases • Trial completion date • Trial primary completion date • Oncology

Beyond Cancer Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors (GlobeNewswire) - "Beyond Cancer, Ltd...today announced 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....We expect to build upon the positive initial preliminary efficacy data presented at this year’s SITC annual meeting demonstrating evidence of immune system activation with further updates at major medical conferences in 2024."

P1 data • Trial status • Oncology • Solid Tumor

Phase 1 study of ultra-high concentration nitric oxide ablation in relapsed or refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies (SITC 2023) - P1 | "This study was approved by the Israel Ministry of Health (Form 8; 202124820) as well as the participating institution’s Ethics Board. Written informed consent was obtained for all enrolled subjects and a copy of the written consent is available for review."

Metastases • P1 data • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor

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 (GlobeNewswire) - P1 | N=38 | NCT05351502 | Sponsor: Beyond Air Inc. | "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."

P1 data • Oncology • Solid Tumor

Intratumoral Administration of High-Concentration Nitric Oxide and Anti-mPD-1 Treatment Improves Tumor Regression Rates and Survival in CT26 Tumor-Bearing Mice. (PubMed, Cells) - "Combining high-concentration NO and immune checkpoint inhibitors warrants further assessment especially in tumors resistant to checkpoint inhibitor therapy."

IO biomarker • Journal • Preclinical • Oncology • Solid Tumor • CD8 • PD-L1

Beyond Cancer Presents Positive Preclinical Data for Ultra-High Concentration Nitric Oxide (UNO) in Combination with Checkpoint Inhibitor Therapy During the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "50,000 or 100,000 ppm UNO alone or in combination with anti-mCTLA-4 more than tripled antigen specific central memory T-cell response versus anti-mCTLA-4 alone...Pooled analysis of combination studies of 50,000 or 100,000 ppm UNO with anti-mPD-1 demonstrated more than a doubling in survival at Day 75 versus anti-mPD-1 alone....Initial data from a Phase 1a, first-in-human study to be presented at the Society for Immunotherapy in Cancer (SITC) on November 3, 2023."

P1 data • Preclinical • Oncology • Solid Tumor

Beyond Cancer Publishes Pre-Clinical Data in Cells Demonstrating that the Combination of Ultra-High Concentration Nitric Oxide (UNO) and Anti-mPD-1 Therapy Improves Tumor Regression Rates and Survival in Mice (GlobeNewswire) - "Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc...announced today the publication of pre-clinical data demonstrating that its proprietary technology reduces immunosuppression and creates a favorable microenvironment that can contribute to immune potentiation....Specifically, in vitro studies showed that PD-L1 was upregulated in both CT26 and 4T1 tumor models following exposure to UNO, implying a possible mechanism for overcoming PD-1 resistance. Intratumorally, UNO resulted in a substantial and enduring reduction in the T-reg/CD8+ ratio demonstrating a less tumorigenic microenvironment."

Preclinical • Oncology

Beyond Cancer Selected to Present Proffered Posters Discussing Data from the UNO Therapy Program at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (GlobeNewswire) - "Beyond Cancer, Ltd...announced that Beyond Cancer, Ltd. will present two proffered posters at the upcoming American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics 2023, which is scheduled to be held October 11th – 15th in Boston, Massachusetts."

Preclinical • Oncology • Solid Tumor

Beyond Air Reports Financial Results for Fourth Quarter and Fiscal Year-End 2023 (GlobeNewswire) - "Beyond Cancer - Solid Tumor Program: (i) Received a notice of allowance for its patent titled, 'System and Method for Delivery or Gas to a Tissue', which is the first patent covering Beyond Cancer’s UNO therapy; (ii) Continue to see a similar immune profile in our phase 1a human study (UNO monotherapy) as seen in pre-clinical studies in mice; (iii) Phase 1a data expected to be released before year end 2023."

P1 data • Patent • Oncology • Solid Tumor

Beyond Cance to Present Two Posters for Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2023 AACR Annual Meeting (GlobeNewswire) - "Beyond Cancer, Ltd., an affiliate of Beyond Air...that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that Beyond Cancer, Ltd. will present two posters at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2023, which is scheduled to be held April 14-19 in Orlando, Florida."

Preclinical • Oncology • Solid Tumor

Gaseous nitric oxide tumor ablation induces an anti-tumor abscopal effect. (PubMed, Cancer Cell Int) - "Taken together, our data demonstrate that UHCgNO followed by the surgical removal of the primary tumor 14 days later induces a strong and potent anti-tumor response."

Journal • Lung Cancer • Oncology • Solid Tumor

Beyond Cancer Publishes Pre-Clinical Data in Cancer Cell International Demonstrating Its Tumor Ablation Method Utilizing Ultra-High Concentration Nitric Oxide (UNO) Induced a Systemic Response that Prevents Metastases (GlobeNewswire) - "Beyond Cancer, Ltd....announced today the publication of pre-clinical data demonstrating that its proprietary tumor ablation technology utilizing UNO results in a potent innate and adaptive immune response that prevents metastases and resulted in a statistically significant survival benefit....at day 55, all of the mice treated with 50,000 ppm gNO rejected the secondary CT26 cell inoculation versus none of the mice in the naïve group. In addition, 73% of the mice treated with 20,000 ppm gNO rejected the secondary inoculation, also a significantly better result than naïve control."

Preclinical • Oncology • Solid Tumor

Beyond Cancer Presents Promising New In Vivo Data Showing Ultra-High Concentration Nitric Oxide Therapy (UNO) in Combination with Anti-PD-1 During the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting (GlobeNewswire) - "Beyond Cancer...announced promising new in vivo combination data that support the potential of the company’s novel gaseous nitric oxide (gNO) therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor (ICI) therapies, including anti-PD-1. These data were published in an abstract by the Society for Immunotherapy of Cancer (SITC) and will be presented in a poster presentation today at the 37th Annual SITC Meeting in Boston, MA."

Preclinical • Oncology • Solid Tumor