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

UNO therapy results in a more immunogenic tumor microenvironment (TME) as well as a systemic response that overcomes anti-PD-1 resistance

First-in-human Phase 1 clinical study is ongoing with initial data expected to be released on November 3^rd at the Society for Immunotherapy of Cancer (SITC) Annual Meeting

GARDEN CITY, NY and HAMILTON, BERMUDA, October 17, 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, 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.

The data were published in an article entitled, “Intratumoral Administration of High-Concentration Nitric Oxide and Anti-mPD-1 Treatment Improves Tumor Regression Rates and Survival in CT26 Tumor-Bearing Mice,” in the peer-reviewed journal Cells. The article is available on the Cells website. (click here).

“The combination of UNO and anti-mPD-1 resulted in a potent, synergistic immune response,” stated Dr. Hila Confino, Head of In Vivo Studies. “This work aligns with prior data utilizing UNO to treat solid tumors and has repeatedly demonstrated increased tumor regression rates and improvement in survival.”

Dr. Frederick Dirbas, MD, Associate Professor of Surgery, Div of Surgical Oncology, Dept of Surgery, Stanford University School of Medicine and Chair of the Beyond Cancer Scientific Advisory Board commented, “This manuscript details the beneficial effects of UNO alone and in conjunction with immunotherapy in a murine tumor model. The boost seen with the combination of UNO and immunotherapy is important. We look forward to further investigation exploring mechanisms of action of UNO as well as the potential merits of UNO in treating human solid tumors.” 

The manuscript published in Cells describes several studies elucidating UNO’s effect on both the adaptive and innate immune responses, as well as tumor responses, to a single administration of therapy.  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 (Figure 1). 

Figure 1: PD-L1 Upregulation in CT26 and 4T1 Cells after In Vitro Exposure to UNO

Intratumorally, UNO resulted in a substantial and enduring reduction in the T-reg/CD8+ ratio demonstrating a less tumorigenic microenvironment (Figure 2). 

Figure 2: T-cell profiling in tumors of CT26 mice treated with UNO

Systemically, the acute effects of UNO treatment included a decrease in MDSC’s and simultaneous increase in M1 macrophages, demonstrating a more immunogenic blood profile (Figure 3).

Figure 3: Myeloid cell profiling in CT26 tumors treated with UNO

“The publication of our second peer-reviewed manuscript in the journal Cells further demonstrates the acceptance of the science of UNO by an expanding community of researchers,” said Dr. Selena Chaisson, Chief Executive Officer. “I am excited for the presentation of our initial clinical data at SITC.”

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. Fred 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
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