Ascendis Pharma reported new and updated results from its ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 ss/? in a poster presentation at ASCO 2024, the annual meeting of the American Society of Clinical Oncology being held in Chicago May 31-June 4. Data included the first presentation of Phase 2 dose expansion Cohort 4 in post anti-PD-1 melanoma and new analyses of patients from dose escalation cohorts with prior disease progression on checkpoint inhibitors, along with biomarker studies correlating cytotoxic immune cell expansion and clinical benefit. As of the April 16, data cutoff, confirmed clinical responses were observed in 40% of efficacy-evaluable patients from Cohort 4, suggesting potential synergy of Ascendis Pharma’s two novel immunotherapy agents.”We are very encouraged by the clinical response and safety profile for TransCon IL-2 ss/? and are pleased to see it working as designed to recruit and amplify the body’s immune response with sustained immune activation without a corresponding increase in markers of toxicity,” said Stina Singel, M.D., Ph.D., Ascendis Pharma’s Executive Vice President and Head of Clinical Development, Oncology. “These new data in a heavily pre-treated population who progressed on or did not benefit from prior checkpoint inhibitors support TransCon IL-2 ss/? as the first biased IL-2 cytokine therapy to show not only monotherapy activity in a convenient outpatient setting every 3 weeks but also a direct correlation between clinical benefit and expansion of CD8+ T cells. We look forward to additional data readouts expected later this year from larger, indication-specific cohorts.”
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