No dose limiting toxicities were reported in the first cohort of ultra-high concentration of nitric oxide administered at 25,000 parts per million (PPM)
Phase 1 study continues to recruit eligible patients in the next protocol defined cohort of 50,000 ppm in multiple centers in Israel
HAMILTON, Bermuda, Dec. 27, 2023 — Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) and a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that the Phase 1 Study evaluating UNO in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities.
The first-in-human, open-label, non-randomized Phase 1 study is being conducted in two parts: Dose Escalation and Dose Expansion. The Dose Escalation consists of three UNO cohorts (25,000, 50,000 and 100,000 ppm) of three to six patients. The Dose Expansion will begin once the recommended dose is determined in the Dose Escalation portion. The primary objective of the trial is to assess the safety and tolerability of UNO with a secondary objective of assessment of efficacy by immune biomarker response to UNO therapy.
“We are delighted to advance to the next cohort of our Phase 1 trial with no reported dose limiting toxicities,” said Dr. Jedidiah Monson, Beyond Cancer’s Chief Medical Officer. “The well tolerated administration of UNO is encouraging and the feasibility of UNO administration in patients has been demonstrated. We look forward to completing Dose Escalation, advancing the UNO development program to the Dose Expansion portion of the study, and future combinations with immune checkpoint inhibitors. We expect to build upon the positive initial preliminary efficacy data presented at this year’s SITC annual meeting demonstrating evidence of immune system activation with further updates at major medical conferences in 2024.”
Additional information about this trial is available at clinicaltrials.gov (NCT#05351502).
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. is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide 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. Beyond Cancer, Ltd. is also 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 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.
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, Ltd.’s ability to raise additional capital; the timing and results of future pre-clinical 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; 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. Beyond Cancer, Ltd. undertakes 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
