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
GARDEN CITY, N.Y. and HAMILTON, Bermuda, Oct. 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, today announced 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. These data were presented in two posters at the 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 was held October 11th – 15th in Boston, Massachusetts. Full abstracts and posters are available on the company’s website (click here).
“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.
About Beyond Cancer, Ltd.
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human study is underway in patients with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. The company’s Scientific Advisory Board (SAB) includes several prominent key opinion leaders in oncology including Dr. Frederick Dirbas, Assoc. Prof. of Surgery, Div. of Surgical Oncology, Stanford University School of Medicine, Dr. Sunil Panchal, President of the National Institute of Spine and Pain, and Dr. Mark Pegram, Susy Yuan-Huey Hung Professor of Medicine (Oncology), Medical Director, Clinical Translational Research Unit, and Associate Dean for Clinical Research Quality at Stanford University.
For more information, visit www.beyondcancer.com.
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately 90% of all cancer-related deaths. Current cancer treatment modalities generally include chemotherapy, immunotherapy, radiation, and/or surgery. Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease. In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models. Beyond Cancer, Ltd. believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment and with limited toxicity or off-target effects.
About Beyond Air®, Inc.
Beyond Air is a commercial stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. The Company has received FDA approval for its first system, LungFit® PH for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), and nontuberculous mycobacteria (NTM). The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of Autism Spectrum disorder (ADS) and other neurological disorders. Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit www.beyondair.net.
Forward Looking Statements
This press release contains “forward-looking statements” concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “expects,” “plans,” “anticipates,” “believes” “expects,” “intends,” “looks,” “projects,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: Beyond Cancer’s ability to raise additional capital; the timing and results of future preclinical studies and clinical trials concerning the ultra-high concentration nitric oxide product candidate; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for the ultra-high concentration nitric oxide product candidate; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; Beyond Cancer’s ability to fund and the results of further preclinical studies and clinical trials of the ultra-high concentration nitric oxide product candidate; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; broad acceptance of the Company’s conclusive interpretation of its research results, potential delay or disruption in our operations resulting from military activity in and around Israel and other risks, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air’s most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air’s website. Beyond Cancer and Beyond Air undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Corey Davis, PhD
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
Matt Johnson, Head of Corporate Development & Strategy
Beyond Cancer, Ltd.
Mjohnson@beyondcancer.com
