• Single and repeat dosing of UNO improves outcomes compared to checkpoint inhibitor monotherapy in the aggressive 4T1 breast cancer model
  
• mPD-L1 upregulation following UNO treatment helps to elucidate the mechanism for the previously reported sensitization of tumors to immune checkpoint blockade
• Phase 1 first-in-human study ongoing and expanded to multiple centers

GARDEN CITY, N.Y. and HAMILTON, Bermuda, April 19, 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 promising new in vivo and in vitro data that support the potential of the company’s novel UNO therapy to treat various types of solid tumors as a single agent and in combination with checkpoint inhibitors. These data were presented today at the American Association for Cancer Research (AACR) Annual Meeting 2023, which is being held in Orlando, Florida from April 14^th to 19^th via poster presentations for abstract numbers 6327 and 6363.

“Today’s impressive new data demonstrating that UNO is effective in treating the aggressive murine breast cancer model (4T1) along with evidence of mPD-L1 upregulation is suggestive of UNO’s ability to sensitize tumors to checkpoint therapy. In addition, we are pleased that these new data show efficacious responses from single and repeat doses of UNO,” stated Dr. Selena Chaisson, Chief Executive Officer and Director. “These data are exciting additions to the growing body of evidence supporting UNO as a potential therapeutic option for cancer patients. We look forward to the readout of our first-in-human Phase 1 study later this year. Additional trial sites are being activated throughout Israel to expedite enrollment, increase the diversity of patients, and expand awareness of the safe and effective administration of our UNO technology.”

Abstract #: 6327 describes experiments assessing the ability of single or repeat dosing of UNO to treat 4T1 tumors, which resemble human triple-negative breast cancers (TNBC). Data showed a statistically significant survival benefit for repeat dosing of UNO compared to anti-CTLA-4 as a monotherapy and in combination with anti-PD-1 compared to anti-PD-1 alone. With regard to tumor volume, statistically significant reductions were observed with repeat dosing of UNO versus anti-mPD-1 as a monotherapy and in combination with anti-CTLA-4 versus anti-CTLA-4.

Results from abstract #: 6363 show that short exposures between 10 seconds to one minute of tumor cells to UNO at increasing concentrations of 25,000 ppm to 100,000 ppm NO significantly upregulate mPD-L1 expression in a dose and time-dependent manner. In addition, in vivo experiments exhibited a statistically significant day 1 increase in M1 macrophages, decrease in Tregs, and reduction in tumor cell viability that was maintained through day 5.

“We believe that together with the known ability of nitric oxide to activate and recruit the immune system, the data presented at this year’s AACR annual meeting show that repeat dosing of UNO is feasible and may be effective even in difficult-to-treat, non-immunogenic tumor types. We look forward to presenting additional preclinical data to identify relevant biomarkers and optimize UNO combination regimens and administration schedules,” stated Hila Confino, Chief Scientific Officer of Beyond Cancer.

Dr. Mark Pegram, a member of the Beyond Cancer Scientific Advisory Board, commented, “Triple-negative and metastatic breast cancers have limited treatment options. I look forward to further pre-clinical, and eventually clinical data that may support UNO as a therapeutic agent in these tumors.”

The presentations detailing the in vivo and in vitro data presented at the AACR Annual Meeting 2023, which are titled, “Intratumoral administration of ultra-high concentration nitric oxide (UNO) is more efficacious than anti-mPD-1 therapy in 4T1 tumor-bearing mice” (abstract #: 6327) and “Short-term exposure of cancer cells to ultra-high concentrations of nitric oxide (UNO) activates the mPD-1/mPD-L1 axis and immune response” (abstract #: 6363) will be made available on the company's website (click here).

Details of the poster presentations are as follows:

Title: Intratumoral administration of ultra-high concentration nitric oxide (UNO) is more efficacious than anti-mPD1 therapy in 4T1 tumor-bearing mice
Session Category: Immunology
Session Title: Anticancer Immunotherapeutics
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM - 12:30 PM EST
Location: Orange County Convention Center, Poster Section 22
Poster Board Number: 3
Abstract Number: 6327
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer

Title: Short-term exposure of cancer cells to ultra-high concentrations of nitric oxide (UNO) activates the mPD-1/mPD-L1 axis and immune response
Session Category: Immunology
Session Title: Immune Checkpoints
Session Date and Time: Wednesday, Apr 19, 2023, 9:00 AM - 12:30 PM EST
Location: Orange County Convention Center, Poster Section 23
Poster Board Number: 7
Abstract Number: 6363
Participant: Hila Confino, PhD; Chief Scientific Officer, Beyond Cancer

About Nitric Oxide

Nitric Oxide 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. The Company 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 medical device and biopharmaceutical company dedicated to harnessing the power of nitric oxide through its 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. Beyond Air has received FDA approval for its first system, LungFit PH for persistent pulmonary hypertension of the newborn. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19), nontuberculous mycobacteria (NTM) and severe lung infections in other settings. 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, 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
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(212) 915-2577

Matt Johnson, Head of Corporate Development & Strategy
Beyond Cancer, Ltd.
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