On September 28, 2026 Currus Biologics, an Australian biotech developing the BEAT, a proprietary, universal, bispecific antibody platform to unlock CAR T-cell therapy for solid tumours, reported 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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CAR T-cell therapies have proved highly effective against blood cancers, yet their impact in solid tumours, which account for around 90% of all cancers, remains limited. In solid tumours, CAR T-cells face a highly immunosuppressive tumour microenvironment (TME) that drives exhaustion and restricts their ability to expand, persist and infiltrate tumour tissue effectively.

CUR-001 combines Currus’ BEAT (Bispecific Engagers of Antigen Presenting Cells and T cells) bispecific antibody, CURB-001 with CURT-001, a FLAG-tagged autologous CAR T-cell therapy targeting mesothelin, a protein expressed at high levels across a range of solid tumours. The BEAT is designed to activate CAR T-cells in lymphoid tissue by engaging both the CAR T-cells and professional antigen-presenting cells, helping to overcome the suppressive effects of the TME. In preclinical solid tumour models, this approach has enhanced CAR T-cell expansion, persistence and tumour infiltration while generating epitope spreading and immunological memory.

Sam Cobb, Chief Executive Officer of Currus Biologics, said: "Receiving IND clearance from the FDA is a major milestone for Currus and an important step in bringing the BEAT into the clinic. CUR-001 is designed to overcome key barriers that have limited the impact of CAR T-cell therapies in solid tumours, an area of significant unmet need. We are excited to progress CUR-001 into Phase 1 and sincerely thank our team, advisers and investors for their support."

Dr Alessandra Cesano, Chair of the Board, Currus Biologics, commented: "Mesothelin has long been considered an attractive target for CAR T-cell therapy in solid tumours, but achieving durable antitumour activity remains a major challenge."

Dr Swami Murugappan, Chief Medical Officer of Currus Biologics, added: "Despite the transformative impact of CAR T-cell therapy in haematological malignancies, achieving durable responses in solid tumours remains a significant challenge. CUR-001 has been designed to address some of the key biological barriers responsible for this difference by combining mesothelin-targeted CAR T-cells with BEAT-mediated immune activation. We look forward to evaluating the safety, pharmacology and early signs of clinical activity of this approach in patients with advanced solid tumours."

(Press release, Currus Biologics, SEP 28, 2026, View Source [SID1234671128])