Beyond Cancer Reports Early Clinical Activity and Favorable Safety Profile with Interim Data from Phase 1 UNO Trial
MWN-AI** Summary
Beyond Cancer, Ltd., a biotechnology company focusing on innovative cancer treatments, has announced encouraging interim results from its Phase 1 clinical trial, named the UNO trial, evaluating ultra-high concentration nitric oxide (UNO) as an immunotherapy for solid tumors. As part of the trial, which enrolled ten heavily pretreated patients, participants received either 25,000 ppm or 50,000 ppm of UNO injected directly into tumors. Notably, among the ten patients, seven have survived between 19 to 37 months after treatment, with two patients diagnosed with triple-negative breast cancer showing no signs of the disease.
The preliminary findings indicate a favorable safety profile for UNO therapy. Most treatment-related adverse events were Grade 1, and no deaths occurred within 12 weeks post-treatment, aside from one patient who passed away due to disease progression after 25 months. The trial’s outcomes will be part of a poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in April 2026.
Steve Lisi, CEO of Beyond Air, emphasized the promising nature of these results, suggesting that UNO could be an effective treatment option both as a standalone therapy and in combination with existing treatments like anti-PD-1 therapy.
Beyond Cancer is developing UNO therapy to combat the challenges posed by solid tumor metastases, which are responsible for a significant number of cancer-related deaths globally. The treatment leverages nitric oxide's potent biological properties, potentially enhancing immune response and limiting toxicity risk. This latest update marks a crucial step forward in Beyond Cancer's pioneering research and development efforts aimed at improving outcomes for cancer patients. For further details, information will be presented at the AACR Annual Meeting, showcasing ongoing advancements in this revolutionary treatment approach.
MWN-AI** Analysis
Beyond Cancer, Ltd.’s recent announcement regarding early clinical activity and a favorable safety profile for its ultra-high concentration nitric oxide (UNO) therapy from the ongoing Phase 1 UNO trial presents a compelling investment opportunity. The data highlighted significant survival outcomes among heavily pretreated patients, including notable cases of disease remission in individuals with triple-negative breast cancer, a particularly hard-to-treat cancer type. This early efficacy, coupled with a manageable safety profile—where most adverse events were Grade 1—positions Beyond Cancer as a potential leader in the immunotherapy space.
As Beyond Cancer prepares for its AACR Annual Meeting presentation, investor sentiment may rise, spurred by the potential for UNO therapy to serve as a complementary treatment to existing therapies. The trial's indication that UNO could stimulate an anti-tumor immune response through localized administration may bolster its appeal as a forward-thinking solution in oncology treatment paradigms, particularly given the substantial unmet need for advanced cancer therapies.
Investors should consider the implications of this data on Beyond Cancer's valuation. Given the promising early results and the company's focus on a method that could effectively prevent tumor metastasis with limited toxicity, interest from both financial and clinical stakeholders is likely to grow. The ability to leverage this data into meaningful partnerships or potential future funding for extended trials may further enhance Beyond Cancer's market position.
However, investors should remain cautious and aware of the risks inherent in clinical-stage biotechs, including regulatory hurdles and the necessity for further clinical validation. As the biotech market is inherently volatile, monitoring Beyond Cancer's progress and investor communications leading up to and following the AACR presentation will be crucial in making informed investment decisions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
GARDEN CITY, N.Y., March 17, 2026 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an investigational immunotherapeutic for solid tumors and subsidiary of Beyond Air, Inc. (NASDAQ: XAIR), today announced early signs of clinical activity and a favorable safety and tolerability profile from its Phase 1 clinical trial evaluating a single intratumoral UNO injection administered as monotherapy. These data were included in an Online Itinerary Planner issued today for the American Association for Cancer Research (AACR) Annual Meeting 2026, which is scheduled to be held from April 17-22, 2026 at the San Diego Convention Center in San Diego, California.
The Phase 1 trial (NCT05351502) was a clinical proof-of-concept trial that assessed the intratumoral administration of UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions. The trial enrolled ten heavily pretreated patients, including breast cancer (n=6), squamous cell carcinoma (n=2), and melanoma (n=2). Patients received a mean of 5.5 prior systemic therapies and 10.3 total cancer-directed treatments. Six patients received 25,000 ppm UNO and four patients received 50,000 ppm UNO.
As of October 1, 2025, seven of ten patients remain alive between 19 to 37 months following a single UNO injection. One patient died of disease progression 25 months after treatment. Two patients with triple negative breast cancer have no evidence of disease. No deaths occurred within 12 weeks after treatment. Treatment demonstrated a favorable safety and tolerability profile, with most treatment?related adverse events limited to Grade 1. One treatment-related serious adverse event (hypoxia) occurred during administration at 25,000 ppm; the event was not considered dose-limiting and resolved fully.
“The combination of favorable safety and tolerability and early clinical activity strengthen our belief that UNO could serve as a differentiated complement to anti?PD?1 therapy in metastatic disease and perhaps as monotherapy prior to metastases,” said Steve Lisi, Chief Executive Officer of Beyond Air. “The duration of survival in this end-stage, heavily pre-treated population is compelling, and we look forward to future studies to better understand the potential of UNO therapy.”
| AACR Annual Meeting 2026 Poster Presentation Details: | |
| Session Category: | Experimental and Molecular Therapeutics |
| Session Title: | Innovative Therapeutic Modalities and Translational Platforms |
| Session Start: | April 19, 2026 at 5:00 PM ET / 2:00 PM PT |
| Session End: | April 19, 2026 at 8:00 PM ET / 5:00 PM PT |
| Location: | Poster Section 13, San Diego Convention Center |
| Poster Board Number: | 22 |
| Poster Number: | 304 |
The poster presentation at AACR will include data from an updated analysis of the ongoing Phase 1 trial beyond what is reflected in the published abstract referenced in this release.
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 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 Cancer, Ltd.
Beyond Cancer, Ltd. 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. For more information, visit www.beyondcancer.com.
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 and CE Mark 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 revolutionary 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).
Additionally, 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, tolerability 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, but are not limited to, statements regarding the potential safety, tolerability, efficacy and therapeutic potential of ultra-high concentration nitric oxide (UNO”); the significance of interim clinical data from Beyond Cancer’s Phase 1 trial; the potential for UNO to be studied as a monotherapy, in combination with anti-PD-1 therapy, or in earlier lines of treatment; the expected content and timing of the AACR presentation; and the development, clinical, regulatory, and commercial prospects of Beyond Cancer’s and Beyond Air’s product candidates. Forward-looking statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “goal,” “intend,” “look,” “may,” “plan,” “potential,” “project,” “target,” “will,” “would,” and similar expressions, 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, many of which are outside the control of Beyond Air or Beyond Cancer, 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 the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; 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. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except as required by law, Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Investor Relations contacts
Corey Davis, Ph.D.
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
FAQ**
How might the early signs of clinical activity reported for Beyond Cancer, Ltd.'s UNO therapy impact the market performance of Beyond Air Inc. (NASDAQ: XAIR)?
What are the implications of the favorable safety and tolerability profile observed in the Phase 1 trial for Beyond Air Inc. XAIR's future drug development strategies?
In what ways could the collaboration between Beyond Cancer, Ltd. and Beyond Air Inc. XAIR enhance the commercial prospects of their nitric oxide-based therapies?
How might the outcomes of the AACR Annual Meeting 2026 presentation affect investor confidence in Beyond Air Inc. XAIR's product pipeline and overall market valuation?
**MWN-AI FAQ is based on asking OpenAI questions about Beyond Air Inc. (NASDAQ: XAIR).
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