Beyond Cancer Receives Approval for Phase 1b Trial of LV-UNO with Anti-PD-1 Therapy in Solid Tumors
Key Insights
Beyond Cancer (search), Ltd. has received approval from the Israeli Ministry of Health to begin a Phase 1b clinical trial of LV-UNO (search) in combination with anti-PD-1 therapy (search).
The trial will evaluate LV-UNO (search) in patients with unresectable cutaneous or subcutaneous solid tumors (search) who have progressed or maintained stable disease on PD-1 (search) inhibitors.
The primary goal is to measure the objective response rate (ORR) and duration of response (DOR), along with assessing immune-related responses, with patient recruitment starting in early 2025.
Beyond Cancer (search), Ltd., a majority-owned affiliate of Beyond Air (search), Inc., has announced approval from the Israeli Ministry of Health to proceed with a Phase 1b clinical trial evaluating Low Volume UNO (LV-UNO (search)) in combination with anti-PD-1 therapy (search) for patients with solid tumors (search). This trial aims to assess the efficacy and safety of LV-UNO in patients who have either progressed or maintained prolonged stable disease on single-agent PD-1 (search) inhibitors, potentially offering a new treatment avenue for those with limited options.
Trial Design and Objectives
The Phase 1b study will focus on patients with unresectable cutaneous or subcutaneous primary or metastatic solid tumor cancers (search). The primary objective is to measure the preliminary efficacy through objective response rate (ORR) and duration of response (DOR) based on RECIST version 1.1 guidelines. The trial will also assess immune-related responses using iRECIST criteria. Patient recruitment is scheduled to commence in early 2025 across four sites in Israel.
Rationale for LV-UNO and Anti-PD-1 Combination
The rationale behind combining LV-UNO (search) with anti-PD-1 therapy (search) stems from preclinical studies that demonstrated promising outcomes. According to Dr. Jedidiah Monson, Chief Medical Officer of Beyond Cancer (search), UNO exhibited increased PD-L1 (search) expression and enhanced overall survival compared to anti-PD-1 (search) treatment alone. This suggests that LV-UNO could enhance the effectiveness of PD-1 inhibitors, particularly in patients who are refractory or resistant to these therapies.
Potential Impact on Cancer Treatment
Dr. Selena Chaisson, CEO and Director of Beyond Cancer (search), highlighted the initiation of the Phase 1b trial as a crucial step in advancing personalized cancer care. She envisions UNO as a promising adjunct therapy for future cancer treatments, potentially offering broader access to effective treatment options for individuals with anti-PD-1 (search) refractory or resistant conditions. The use of ultra-high concentration nitric oxide (UNO) via a proprietary delivery system aims to treat primary tumors and prevent metastases, potentially minimizing relapse or metastatic disease with limited toxicity.
Nitric Oxide in Cancer Therapy
Beyond Cancer (search)'s approach involves using ultra-high concentration nitric oxide (UNO) through a proprietary delivery system to treat primary tumors and prevent metastases. This innovative strategy seeks to minimize relapse or metastatic disease with potentially limited toxicity or off-target effects, even with short treatment durations, such as a single 5-minute session. The trial represents a significant step forward in exploring nitric oxide's potential in cancer therapy, offering hope for improved outcomes in cancer treatment paradigms worldwide.