GARDEN CITY, N.Y. and HAMILTON, Bermuda, Jan. 30, 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, announced today the appointment of Gavin Choy, PharmD as Chief Operating Officer. He brings more than 20 years of expertise to Beyond Cancer in the development of small molecules as well as immunotherapy in oncology with the successful management of multiple early first-in-human studies in the U.S. and Australia/New Zealand, and late-stage registrational clinical studies globally, as well as early access, and compassionate use programs.

“Gavin’s extensive experience facilitating new drug products through the clinical trial process is a welcomed addition to the talented team at Beyond Cancer,” commented Selena Chaisson, Chief Executive Officer of Beyond Cancer. “Gavin will be instrumental in our efforts to begin clinical trials in the U.S. and successfully develop UNO as a therapeutic option for patients with solid tumors.”

“I am thrilled to partner with the talented and innovative Beyond Cancer team to advance UNO into additional clinical studies,” remarked Dr. Choy. “Harnessing ultra-high concentration nitric oxide to engage the immune system with the aim of preventing metastatic disease and relapse across a variety of solid tumors can be a potentially viable treatment option added to the existing armamentarium of therapeutics for the treatment of solid tumors.”

Dr. Choy has held various executive leadership roles in the pharmaceutical and biotechnology industry and has extensive experience leading cross-functional teams in early-, mid-, and late-stage clinical development programs. Dr. Choy successfully led or was an integral member of a team in four New Drug Applications (NDA) and seven Investigational New Drugs (IND) and has experience in achieving Fast Track and Orphan Drug Designations. He has also led a lead asset into a global Phase 2 program in fourteen countries with approximately 100 clinical investigative sites. He most recently served as Chief Clinical Development Officer at GT Biopharma where he authored an orphan drug application submission, co-authored an abbreviated clinical study report, and implemented their quality system. Prior to his role at GT Biopharma, he served as Chief Operating Officer at Apollomics, Inc. and was President at CG Pharmaceuticals, Inc. Dr. Choy is the co-founder and Chief Operating Officer of Adaptive Research, Inc., a healthcare ecosystem that enables physicians to participate in clinical trials and engages biotechnology and pharmaceutical sponsors to expand access to larger eligible and diverse patient pools in community settings.

Throughout Dr. Choy’s career, he has prolifically published manuscripts, abstracts and journal articles with over 75 peer-reviewed publications to his credit. Dr. Choy has 18 years of clinical experience in hematology/oncology/bone marrow transplantation and geriatrics at the Department of Veterans Affairs and Stanford University Hospital.

Dr. Choy received his Doctor of Pharmacy from the University of Southern California and completed residency training at the University of Southern California and at the U.S. Department of Veteran Affairs, Sepulveda Medical Center. He also holds a Master of Business Administration focused on Health Care from the University of California, Irvine, Paul Merage School of Business.

About Nitric Oxide

Nitric Oxide 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 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.

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 an entirely 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. The Company 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. Additionally, Beyond Cancer, an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the preclinical 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; 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, Ph.D.
LifeSci Advisors, LLC
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(212) 915-2577

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