Data demonstrate the ablation of solid tumors with nitric oxide
All tumor-bearing mice treated with nitric oxide rejected a second tumor challenge, suggesting induction of an anti-tumor immune response
GARDEN CITY, N.Y., June 22, 2020 — Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced in vivo and in vitro data that show the potential efficacy of high concentration nitric oxide in ablation of solid tumors. The data were presented by Dr. Hila Confino of Beyond Air in an e-poster poster titled, “Gaseous Nitric Oxide at High Concentration is a Powerful Anti-Tumor Agent both in-vitro and in-vivo” at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.
Three studies were conducted to characterize the anti-tumor effects of gNO in vivo. In the first study, subcutaneous colon cancer tumors were treated locally with high-dose gNO delivered by intratumoral injection or direct external exposure. Tumor ablation was successful in five of 30 mice.
In the second study, gNO was used to ablate primary tumors in tumor-bearing mice. The NO-treated tumor-bearing mice were later inoculated with a second challenge of tumor cells. All gNO-treated tumor-bearing mice (n=6) rejected the second tumor cell inoculation. In contrast, tumor take was 100% following tumor cell inoculation in naïve mice serving as controls (n=7). These data suggest that an anti-tumor immune response was triggered by gNO ablation of the primary tumor.
In the third study, splenocytes extracted from an NO-treated tumor-bearing mouse were mixed with mouse colon cancer cells and inoculated to naïve mice. The splenocytes dose-dependently inhibited the growth of tumors in the naïve mice, supporting an immune-mediated anti-tumor effect of gNO.
Professor Ido Wolf, the head of the oncology division at Sourasky Medical Center in Tel Aviv, commented, “These data demonstrate the potential utility of gNO as a novel treatment for cancer and indicate that tumor ablation with gNO may stimulate an anti-tumor immune response. This effect could result in the elimination of distant metastases, which account for 90% of cancer deaths.”
“These preclinical data demonstrate that gNO is a novel and potentially powerful treatment for solid tumors,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. “These data show that ultra-high concentration gNO not only has a substantial cytotoxic effect on cancer cells, but also suggest that our treatment may stimulate an anti-tumor immune response. Our goal is to initiate the first human study in the second half of next year.”
In addition to the in vivo studies, in vitro studies demonstrated that exposure of mouse colon and breast cancer cell cultures to high-concentration gNO reduced cell viability by more than 95%, further demonstrating cytotoxic effects of gNO against tumor cells.
About Beyond Air, Inc.
Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company developing a revolutionary NO Generator and Delivery System, LungFit™, that uses NO generated from ambient air to deliver precise amounts of NO to the lungs for the potential treatment of a variety of pulmonary diseases. The LungFit™ can generate up to 400 ppm of NO, for delivery either continuously or for a fixed amount of time and has the ability to either titrate dose on demand or maintain a constant dose. The Company is applying its therapeutic expertise to develop treatments for pulmonary hypertension in various settings, in addition to treatments for respiratory tract infections that are not effectively addressed with current standards of care. Beyond Air is currently advancing its revolutionary LungFit™ for clinical trials for the treatment of severe lung infections such as SARS-CoV-2 and nontuberculous mycobacteria (NTM). Additionally, Beyond Air is using 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.
About Nitric Oxide (NO)
Nitric Oxide (NO) is a powerful 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, including mycobacteria, viruses, fungi, yeast and parasites, and has the potential to eliminate multi-drug resistant strains.
About 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. Nitric oxide at high concentrations has been reported to show anticancer properties and to serve as a chemosensitizer and radiotherapy enhancer. Based on its current findings, Beyond Air is developing treatment protocols using ultra-high nitric oxide concentrations to ablate primary tumors and treat metastatic disease.
Forward Looking Statements
This press release contains “forward-looking statements” concerning inhaled nitric-oxide and the Company’s LungFit™ product, including statements with regard to potential regulatory developments, the potential impact on patients and anticipated benefits associated with its use. Forward-looking statements include statements about our expectations, beliefs, or intentions regarding our product offerings, business, financial condition, results of operations, strategies or prospects. You can identify such forward-looking statements by the words “anticipates,” “expects,” “intends,” “impacts,” “plans,” “projects,” “believes,” “estimates,” “likely,” “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 our 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 our views as of the date they are made with respect to future events and financial performance. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to: our approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; our ability to fund and the results of further pre-clinical and clinical trials; obtaining, maintaining and protecting intellectual property utilized by our products; our ability to enforce our patents against infringers and to defend our patent portfolio against challenges from third parties; our ability to obtain additional funding to support our business activities; our dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of our product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to ours and others developing products for similar uses; our dependence on collaborators; our short operating history and other risks identified and described in more detail in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and other filings with the SEC, all of which are available on our website. We undertake no obligation to update, and we do not have a policy of updating or revising, these forward-looking statements, except as required by applicable law.
Steven Lisi, Chief Executive Officer
Beyond Air, Inc.
Corey Davis, Ph.D.
LifeSci Advisors, LLC