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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 54% decrease. In the 25,000 ppm cohort, the same stimulatory immune biomarkers were upregulated. UNO was generally well tolerated with primarily Grade 1 related toxicities. One Grade 3 adverse event was deemed a dose limiting toxicity in the 50,000 ppm cohort resulting in the expansion of the cohort to six total subjects.
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.
Posted In: XAIR
