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
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- 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, Sept. 28, 2026 (GLOBE NEWSWIRE) — 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 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. For more information, visit www.currusbio.com or follow Currus on LinkedIn.
For further information: Currus Biologics Sam Cobb, CEO E-mail: info@currusbio.com Optimum Strategic Communications Mary Clark, Isabelle Abdou, Henry Williams E-mail: currusbio@optimumcomms.com
