Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors
- The Phase 1 study has cleared the first cohort of 25,000 ppm single dose UNO with no reported dose limiting toxicities, indicating a positive safety profile for the treatment.
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Insights
The announcement that Beyond Cancer, Ltd. has reported no dose limiting toxicities in its Phase 1 Study for ultra-high concentration nitric oxide (UNO) therapy is a significant milestone in the development of new cancer treatments. The progression to the next cohort without safety concerns suggests a favorable risk profile for UNO at this stage, which is crucial for patient safety and regulatory approval processes. The safety review committee's findings are a critical factor in the continuation of the trial and potentially for future investment and partnership opportunities.
UNO's potential as an immunotherapeutic for solid tumors could represent a novel approach in oncology, complementing existing treatments such as immune checkpoint inhibitors. The study's design, with a focus on dose escalation and expansion, is a standard approach in early-phase clinical trials aimed at determining the optimal dose for therapeutic effect while minimizing adverse reactions. The well-tolerated administration of UNO could lead to further research and development, possibly impacting the company's valuation and investor interest positively.
From a market perspective, Beyond Air, Inc.'s progress in the development of UNO therapy is likely to be closely monitored by competitors and potential collaborators within the biotechnology and pharmaceutical sectors. The advancement to higher UNO concentrations without dose limiting toxicities may position the company as a leader in the niche field of ultra-high concentration nitric oxide therapies. This could attract strategic partnerships or licensing deals, especially if the efficacy data continues to show promise.
Investor sentiment in the biotech sector is often influenced by clinical trial outcomes and positive news such as this can lead to increased stock volatility. However, investors should consider the inherent risks of biotech investments, including the long development timelines, the possibility of future trial failures and regulatory hurdles. The anticipation of further updates at major medical conferences in 2024 could maintain investor interest and media attention on Beyond Air, Inc.
As an oncology specialist, the progression of Beyond Cancer’s UNO therapy into the next phase of trials is noteworthy. UNO's immunotherapeutic approach may offer a new avenue for treating advanced, relapsed, or refractory unresectable solid tumors, which are often challenging to treat with current modalities. The lack of dose limiting toxicities at 25,000 ppm is promising, as it suggests a potentially higher therapeutic threshold for UNO, which could translate into more aggressive treatment strategies for patients with fewer side effects.
The secondary objective of assessing efficacy by immune biomarker response is also of interest. Biomarkers are increasingly used to predict and monitor treatment response and positive immune biomarker responses could indicate the activation of the immune system against cancer cells, which is a desirable outcome in immunotherapy. The combination of UNO with immune checkpoint inhibitors could potentially enhance the efficacy of both treatments, offering a synergistic approach to cancer therapy.
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 (GLOBE NEWSWIRE) -- 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
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
FAQ
What is the purpose of the Phase 1 study conducted by Beyond Cancer, Ltd. (NASDAQ: XAIR)?
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