FDA Clears Currus Biologics IND for CUR-001, a BEAT-Enabled Mesothelin CAR T Combination in Solid Tumours
核心洞察
The FDA has cleared Currus Biologics (搜索)' IND for CUR-001 (搜索), allowing a first-in-human Phase 1 basket trial in mesothelin-positive advanced refractory solid tumours (搜索).
CUR-001 (搜索) pairs CURB-001 (搜索), a BEAT bispecific antibody, with CURT-001 (搜索), a FLAG-tagged autologous anti-mesothelin CAR T-cell therapy.
The open-label study is expected to dose its first patient in early 2027, evaluating safety, pharmacology and early signs of clinical activity.
Currus Biologics (搜索) has received U.S. Food and Drug Administration clearance of its Investigational New Drug application for CUR-001 (搜索), the company's lead programme and the first clinical candidate from its BEAT bispecific antibody platform. The clearance allows the Australian biotech to begin a first-in-human Phase 1 basket trial in patients with mesothelin-positive advanced refractory solid tumours (搜索).
CUR-001 (搜索) is a combination regimen. It pairs CURB-001 (搜索), Currus' BEAT (Bispecific Engagers of Antigen Presenting Cells and T cells) bispecific antibody, with CURT-001 (搜索), a FLAG-tagged autologous CAR T-cell therapy targeting mesothelin. Mesothelin is described by the company as a protein expressed at high levels across a range of solid tumours (搜索).
Rationale in Solid Tumours
CAR T-cell therapies have proved highly effective against blood cancers, but their impact in solid tumours (搜索), which account for around 90% of all cancers, remains limited. In solid tumours, CAR T-cells face a highly immunosuppressive tumour microenvironment that drives exhaustion and restricts their ability to expand, persist and infiltrate tumour tissue effectively.
The BEAT is designed to activate CAR T-cells in lymphoid tissue by engaging both the CAR T-cells and professional antigen-presenting cells, an approach intended to overcome the suppressive effects of the tumour microenvironment. In preclinical solid tumour models, this approach enhanced CAR T-cell expansion, persistence and tumour infiltration while generating epitope spreading and immunological memory, according to Currus.
"Receiving IND clearance from the FDA is a major milestone for Currus and an important step in bringing the BEAT into the clinic," said Sam Cobb, Chief Executive Officer of Currus Biologics (搜索). "CUR-001 (搜索) is designed to overcome key barriers that have limited the impact of CAR T-cell therapies in solid tumours (搜索), an area of significant unmet need."
Trial Design and Timeline
The Phase 1 study is an open-label basket trial enrolling patients with mesothelin-positive advanced refractory solid tumours (搜索). Currus expects the first patient to be dosed in early 2027. The company said it looks forward to evaluating the safety, pharmacology and early signs of clinical activity of the combination in patients with advanced solid tumours.
"Despite the transformative impact of CAR T-cell therapy in haematological malignancies, achieving durable responses in solid tumours (搜索) remains a significant challenge," said Dr Swami Murugappan, Chief Medical Officer of Currus Biologics (搜索). "CUR-001 (搜索) 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."
Dr Alessandra Cesano, Chair of the Board at Currus Biologics (搜索), noted the history of the target: "Mesothelin has long been considered an attractive target for CAR T-cell therapy in solid tumours (搜索), but achieving durable antitumour activity remains a major challenge."
Platform Positioning
Currus describes the BEAT as a universal platform compatible with any CAR T-cell format or tumour target. The company states that its approach prevents CAR T-cell exhaustion, drives durable proliferation and persistence, remodels the tumour microenvironment and promotes epitope spreading, with the aim of enabling sustained anti-tumour responses. Currus says the platform is supported by preclinical data and independent academic validation, and positions the BEAT as a cost-effective, flexible add-on for partners as CAR T-cell delivery becomes faster, cheaper and more scalable.
Currus Biologics (搜索) is backed by Brandon Capital Partners, Main Sequence Ventures and Uniseed.