Beyond Cancer Announces Approval by the Israeli Ministry of Health to Conduct a Phase 1b Clinical Trial Utilizing Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in Combination with Anti-PD-1 Therapy
Beyond Cancer has received approval from the Israeli Ministry of Health to conduct a Phase 1b clinical trial evaluating Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in combination with anti-PD-1 therapy. The trial will enroll up to 20 patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumors who have progressed or shown prolonged stable disease on PD-1 inhibitors.
The study will be conducted at four Israeli sites starting Q1 2025, with topline data expected in H2 2025. The primary objective is to assess preliminary efficacy through objective response rate and duration of response. Preclinical studies showed that a single UNO dose increased PD-L1 expression and improved overall survival compared to anti-PD-1 alone.
Beyond Cancer ha ricevuto l'approvazione dal Ministero della Salute israeliano per condurre un trial clinico di Fase 1b che valuta il Nitrossido ad Alta Concentrazione a Basso Volume (LV UNO) in combinazione con la terapia anti-PD-1. Il trial arruolerà fino a 20 pazienti con tumori solidi primari o metastatici, cutanei o sottocutanei, non reseccabili e che hanno mostrato progressione o una malattia stabile prolungata con gli inibitori di PD-1.
Lo studio verrà condotto in quattro centri in Israele a partire dal primo trimestre del 2025, con dati preliminari attesi nel secondo semestre del 2025. L'obiettivo principale è valutare l'efficacia preliminare attraverso il tasso di risposta obiettivo e la durata della risposta. Studi preclinici hanno dimostrato che una singola dose di UNO aumenta l'espressione di PD-L1 e migliora la sopravvivenza generale rispetto all'anti-PD-1 da solo.
Beyond Cancer ha recibido la aprobación del Ministerio de Salud israelí para llevar a cabo un ensayo clínico de fase 1b que evalúa el Óxido Nítrico Ultra-Alto Concentrado de Bajo Volumen (LV UNO) en combinación con la terapia anti-PD-1. El ensayo inscribirá hasta 20 pacientes con tumores sólidos primarios o metastásicos, cutáneos o subcutáneos, no resecables que han mostrado progresión o una enfermedad estable prolongada con los inhibidores de PD-1.
El estudio se llevará a cabo en cuatro sitios en Israel a partir del primer trimestre de 2025, con datos preliminares esperados para el segundo semestre de 2025. El objetivo principal es evaluar la eficacia preliminar a través de la tasa de respuesta objetiva y la duración de la respuesta. Estudios preclínicos mostraron que una dosis única de UNO aumentó la expresión de PD-L1 y mejoró la supervivencia general en comparación con anti-PD-1 solo.
Beyond Cancer는 이스라엘 보건부의 승인을 받아 1b상 임상 시험을 진행하게 되었습니다. 이 시험은 저용량 초고농도 질산산화물(LV UNO)과 항-PD-1 요법의 병용 효과를 평가합니다. 시험에는 절제할 수 없는 피부 또는 피하의 조직학적으로 확인된 원발성 또는 전이성 고형 종양을 가진 환자 최대 20명이 등록될 예정이며, PD-1 억제제에 대해 진행되었거나 장기적으로 안정화된 질병이 확인된 환자들입니다.
연구는 2025년 1분기부터 이스라엘 내 네 곳에서 진행되며, 주요 데이터는 2025년 하반기에 예상됩니다. 주요 목표는 객관적인 반응률과 반응 지속 시간을 통해 초기 효능을 평가하는 것입니다. 전임상 연구에서는 UNO 단일 투여량이 PD-L1 발현을 증가시키고 항-PD-1 단독 사용 시보다 전체 생존률을 개선한 것으로 나타났습니다.
Beyond Cancer a reçu l'approbation du ministère de la Santé israélien pour réaliser un essai clinique de phase 1b évaluant l'Oxyde Nitrique Ultra-Hautes Concentrations à Faible Volume (LV UNO) en combinaison avec la thérapie anti-PD-1. L'essai recrutera jusqu'à 20 patients atteints de tumeurs solides primaires ou métastatiques cutanées ou sous-cutanées, non résécables, ayant montré une progression ou une maladie stable prolongée sous inhibiteurs de PD-1.
L'étude sera conduite sur quatre sites en Israël à partir du premier trimestre 2025, avec des données préliminaires attendues au deuxième semestre 2025. L'objectif principal est d'évaluer l'efficacité préliminaire à travers le taux de réponse objective et la durée de réponse. Des études précliniques ont montré qu'une dose unique de UNO augmentait l'expression de PD-L1 et améliorait la survie globale par rapport à l'anti-PD-1 seul.
Beyond Cancer hat die Genehmigung des israelischen Gesundheitsministeriums erhalten, um eine Phase 1b klinische Studie durchzuführen, die die Kombination von niedrigvolumigem, ultra-hochkonzentriertem Stickoxid (LV UNO) mit einer Anti-PD-1-Therapie bewertet. Die Studie wird bis zu 20 Patienten mit nicht resektablen, histologisch bestätigten, primären oder metastatischen soliden Tumoren einschließen, die unter PD-1-Inhibitoren progressiert sind oder eine verlängerte stabile Erkrankung gezeigt haben.
Die Studie wird an vier Standorten in Israel ab dem ersten Quartal 2025 durchgeführt, wobei die ersten Daten im zweiten Halbjahr 2025 erwartet werden. Das Hauptziel ist die Bewertung der vorläufigen Wirksamkeit durch objektive Ansprechrate und Dauer des Ansprechens. Präklinische Studien haben gezeigt, dass eine einzelne UNO-Dosis die PD-L1-Expression erhöht und das Gesamtüberleben im Vergleich zu anti-PD-1 allein verbessert hat.
- Received regulatory approval from Israeli Ministry of Health for Phase 1b trial
- Previous Phase 1a human data demonstrated immune system activation
- Preclinical studies showed improved survival rates compared to anti-PD-1 alone
- Small trial size to 20 subjects
- Results not expected until second half of 2025
Insights
This clinical trial approval represents a significant milestone in developing a novel cancer immunotherapy approach. The study combines Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) with existing PD-1 inhibitors, targeting patients who have shown response to standard immunotherapy.
Key aspects of the trial design show promise:
- Focus on patients with unresectable or metastatic solid tumors who progressed on PD-1 inhibitors
- Primary endpoints measuring objective response rate and duration of response
- Preclinical data showing increased PD-L1 expression and improved survival
- Phase 1a results already demonstrated immune activation
The 20-patient trial across 4 Israeli sites could provide important proof-of-concept data by H2 2025. The approach of using nitric oxide to potentially enhance immunotherapy response is innovative and could address a significant unmet need in cancer treatment resistance.
For Beyond Cancer's parent company Beyond Air (XAIR), this regulatory approval advances their oncology pipeline significantly. The trial's relatively quick timeline, with screening starting Q1 2025 and topline data expected H2 2025, provides a clear catalyst pathway. Given XAIR's small market cap of
The focus on PD-1 inhibitor-resistant patients is strategically sound, as this represents a large market opportunity. Success in this population could position LV UNO as a valuable combination therapy in the lucrative immuno-oncology space. The company's approach to addressing treatment resistance could attract partnership interest from larger pharmaceutical companies with existing PD-1 inhibitor portfolios.
- The Phase 1b study will evaluate LV UNO in unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumor cancer patients that have progressed or have prolonged stable disease on single agent PD-1 inhibitors
- The primary objective of the Phase 1b study is to assess preliminary efficacy by objective response rate (ORR) and duration of response (DOR) per RECIST version 1.1 and secondarily immune-related response via iRECIST
- The study will recruit patients from four sites across Israel
HAMILTON, Bermuda, Dec. 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, today announced that the Israeli Ministry of Health (IMOH) has approved the use of Low Volume UNO (LV UNO) in a Phase 1b clinical trial of LV UNO in combination with anti-PD-1 therapy. The trial will be conducted at four sites in Israel and patient screening will begin in the first quarter of 2025.
The Phase 1b trial (NCT05351502) is a clinical proof-of-concept trial that will assess the intratumoral administration of LV UNO in patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (≥ 12 weeks) after receiving a single agent anti-PD-1 containing treatment. The trial, which is expected to enroll up to 20 subjects, is designed to assess the preliminary efficacy of LV UNO by objective response rate (ORR) and duration of response (DOR) per RECIST v1.1 and secondarily immune-related response via iRECIST. Safety and tolerability of LV UNO in combination with anti-PD-1 therapy, as well as its potential to enhance the type, density, and distribution of immune cells within the tumor microenvironment will also be observed. Topline data from the Phase 1b portion of the study are anticipated in the second half of 2025.
“We are excited to initiate the Phase 1b trial of LV UNO, a potentially groundbreaking solid tumor treatment approach, in combination with PD-1 inhibitors,” said Dr. Jedidiah Monson, Chief Medical Officer of Beyond Cancer. “In preclinical studies, a single dose of UNO has been shown to increase PD-L1 expression and improve overall survival in animal models compared to anti-PD-1 alone. Further, Phase 1a human data that demonstrated immune system activation were presented at ASCO’s Key Opinion Leader Event held in June 2024. We look forward to the Phase 1b trial results to establish the basis of further investigation of UNO in combination with PD-1 inhibitors.”
“The initiation of the Phase 1b trial represents a major step forward in our vision for personalized cancer treatment. We see UNO as a complementary therapy for future cancer treatment paradigms, particularly for patients with anti-PD-1 refractory or resistant disease, potentially offering more patients access to effective treatment,” stated Dr. Selena Chaisson, Chief Executive Officer, and Director of Beyond Cancer.
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
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 forward,” “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 the 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; 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 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, PhD
LifeSci Advisors, LLC
Cdavis@lifesciadvisors.com
(212) 915-2577
Matt Johnson, Head of Corporate Development & Strategy
Beyond Cancer, Ltd.
Mjohnson@beyondcancer.com
FAQ
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