Currus Biologics announces FDA IND clearance for Phase 1 trial of CUR-001 in mesothelin-positive advanced refractory solid tumours

  • The first clinical programme from Currus’ BEAT platform, designed to overcome the barriers that have limited CAR T-cell therapy in solid tumours

  • CUR-001 combines CURB-001, Currus’ BEAT bispecific antibody, with CURT-001, its FLAG-tagged autologous anti-mesothelin CAR T-cell therapy

  • The open-label basket study will enrol patients with mesothelin-positive advanced refractory solid tumours, with the first patient expected to be dosed in early 2027

Melbourne, Australia, 29 September 2026 – Currus Biologics, an Australian biotech developing the BEAT, a proprietary, universal, bispecific antibody platform to unlock CAR T-cell therapy for solid tumours, today announces that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for its lead programme, CUR-001. The clearance enables Currus to initiate a first-in-human Phase 1 basket trial in patients with mesothelin-positive advanced refractory solid tumours.

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