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, 30 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.
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."
About us:
About Currus Biologics
Currus Biologics is an Australian biotechnology company developing a proprietary BEAT (Bispecific Engagers of Antigen Presenting Cells and T cells) bispecific antibody platform to unlock CAR T-cell therapy for solid tumours. The BEAT rewires immune activation by simultaneously engaging antigen-presenting cells and CAR T-cells to overcome the biological barriers that have limited CAR T-cell efficacy in solid tumours. The Company's approach prevents CAR T-cell exhaustion, drives durable proliferation and persistence, remodels the tumour microenvironment, and promotes epitope spreading, enabling robust and sustained anti-tumour responses.
The BEAT is a universal solution compatible with any CAR T-cell format or tumour target. Supported by robust preclinical data and independent academic validation, the Company's lead clinical programme, CUR-001, targets mesothelin-positive advanced solid tumours with a clear path to clinical PoC. As CAR T-cell delivery becomes faster, cheaper, and more scalable, the BEAT provides a cost-effective, flexible add-on, enabling partners to unlock their technology and deliver life-changing outcomes for patients.
With a focused, rigorous team and world-class scientific advisors, Currus is committed to clinical validation, strategic partnerships, and advancing the next phase of cell therapy to transform cancer treatment by unlocking the potential of CAR T-cell therapies in solid tumours, which represent ~90% of the oncology market. Currus is backed by Brandon Capital Partners, Main Sequence Ventures, and Uniseed.
