Beyond Cancer Presents First-in-Class Clinical Data Showing an Immunogenic Response in Subjects with r/r Unresectable Solid Tumors Treated with Ultra-High Concentration Nitric Oxide (UNO)
Beyond Cancer has revealed promising Phase 1a clinical data for their ultra-high concentration nitric oxide (UNO) platform, showing early tumor responses and immune system activation in subjects with relapsed or refractory unresectable solid tumors.
Data presented at the 2024 American Society of Clinical Oncology Annual Meeting highlighted immune biomarker responses, including increases in dendritic cells, cytotoxic T-cells, and central memory T-cells, along with a decrease of 54% in Myeloid Derived Suppressor Cells (MDSCs) post-treatment.
The Phase 1b trial, combining UNO with anti-PD-1 therapy, has been filed for regulatory approval and aims to enroll up to 20 subjects. UNO was generally well-tolerated, with primarily Grade 1 toxicities and one Grade 3 adverse event noted.
- Phase 1a data shows early tumor responses and immune system activation.
- Increased immune biomarkers like dendritic cells and cytotoxic T-cells observed.
- 54% reduction in Myeloid Derived Suppressor Cells (MDSCs).
- UNO treatment led to clinical resolution of radiation-induced dermatitis in TNBC subject.
- Phase 1b trial combining UNO with anti-PD-1 therapy filed for regulatory approval.
- UNO was generally well-tolerated with mostly Grade 1 toxicities.
- One Grade 3 adverse event was identified as a dose-limiting toxicity in the 50,000 ppm cohort.
- Only six subjects were added to the 50,000 ppm cohort after observing dose-limiting toxicity.
- The trial's success hinges on future regulatory approval and successful enrollment for Phase 1b.
Insights
The clinical data from Beyond Cancer’s ongoing Phase 1a trial of Ultra-High Concentration Nitric Oxide (UNO) is significant for oncology treatment. Observing notable immune biomarker responses like increases in dendritic cells, cytotoxic T-cells and central memory T-cells, alongside a favorable M1/M2 ratio, underscores the potential of UNO to enhance immune system activity in patients with difficult-to-treat cancers.
The ability to achieve an immunogenic response even in relapsed or refractory cases suggests that UNO may offer a new therapeutic avenue for patients who have exhausted conventional treatments. However, it’s important to observe long-term results and larger sample sizes to validate these findings, particularly focusing on any unforeseen immune-related adverse events and overall survival benefit.
From a clinical perspective, the development of UNO as an immunotherapeutic agent could significantly change the treatment landscape for solid tumors, offering hope for enhanced efficacy and safety over existing therapies.
Analyzing the data from a medical research standpoint, Beyond Cancer's report on UNO's efficacy in solid tumors shows a promising leap in cancer treatment innovation. The demonstrated decrease in Myeloid Derived Suppressor Cells (MDSCs) by
Furthermore, the expansion to a Phase 1b trial to include combination therapy with anti-PD-1 antibodies could harness the complementary mechanisms of action, potentially improving patient outcomes in a synergistic manner. This trial's design and results will be critical to observe as it may provide a robust dataset on the safety and efficacy of such combined treatments.
– Ongoing Phase 1a first-in-human clinical trial continues to demonstrate proof of concept for the UNO solid tumor platform with observed early tumor responses and clinical resolution of radiation dermatitis
– Phase 1a data continue to support feasibility of administering UNO at ultra-high concentrations with immune biomarkers at 50,000 parts per million (ppm) demonstrating an immunogenic response
– Phase 1b protocol of UNO in combination with anti-PD-1 antibody therapy filed for regulatory approval
– Phase 1a clinical data and Phase 1b study design unveiled at 2024 American Society of Oncology Annual Meeting
HAMILTON, Bermuda, June 03, 2024 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., a clinical-stage biotechnology company developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, announced encouraging first-in-class clinical data demonstrating evidence of immune system activation via biomarker response in a heavily pretreated population in the ongoing Phase 1a trial. The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of UNO as an immunotherapeutic up to 50,000 parts per million. These data were presented at the American Society of Clinical Oncology Key Opinion Leader Event held in conjunction with the 2024 Annual Meeting in Chicago, Illinois.
The Company also reported a case of relapsed/refractory Triple Negative Breast Cancer (TNBC) in which the subject showed no evidence of malignancy in a satellite lesion 21 days following UNO treatment and a corollary, rapid and durable clinical resolution of radiation-induced dermatitis.
The immune biomarker data at Day 21, following a single 5 minute dose of UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic T-cells, central memory T-cells and a favorable increase in the M1/M2 ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed a
The Phase 1b trial has been submitted to the Israeli Ministry of Health (IMOH) and upon regulatory approval will enroll up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (≥ 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with the UNO + anti-PD-1 combination upon completion of the Phase 1a trial.
“We are excited to present first-in-class data that demonstrate the potential of UNO to induce a clinically meaningful response in a subject with triple-negative breast cancer who was highly refractory to standard of care therapy, with complete resolution of the radiation-induced dermatitis. The safety profile and promising anti-tumor activity observed in this Phase 1a study provide a strong foundation to advance UNO in the clinical setting,” said Jedidiah Monson, MD, Chief Medical Officer of Beyond Cancer. “We look forward to future results of the planned Phase 1b trial in combination with PD-1 inhibitor therapy and potentially expand its application to other cancer types.”
About UNO Therapy for Solid Tumors
Cancer is the second leading cause of death globally, with tumor metastases responsible for approximately
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 (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. Beyond Cancer is also conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols. For more information, visit www.beyondcancer.com.
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, which may, in part, be identified and described in the “Risk Factors” section of Beyond Air, Inc.’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, Inc.’s website. Beyond Cancer, Ltd. and Beyond Air, Inc. undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law.
CONTACTS:
Matt Johnson, Head of Corporate Development & Strategy
Beyond Cancer, Ltd.
Mjohnson@beyondcancer.com
FAQ
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