- Octane Biotech and Currus Biologics have automated the manufacturing process for CUR-001 on Octane’s Cocoon Platform, establishing a closed process ahead of clinical development.
- CUR-001 is expected to enter a first-in-human Phase 1 trial in patients with mesothelin-positive advanced refractory solid tumors, with the first patient expected to be dosed in early 2027.
Octane Biotech Inc. and Currus Biologics have successfully automated the manufacturing process for CUR-001, Currus’ lead clinical candidate, using Octane’s Cocoon Platform. The technology transfer establishes a closed manufacturing process designed to support consistent production as the autologous CAR T-cell therapy advances toward clinical development.
The milestone follows U.S. Food and Drug Administration (FDA) clearance of Currus’ investigational new drug application for CUR-001 in September 2026. The clearance allows the company to begin a first-in-human, open-label Phase 1 basket trial in patients with mesothelin-positive advanced refractory solid tumors. The first patient is expected to be dosed in early 2027.
CUR-001 combines an autologous, FLAG-tagged CAR T-cell therapy targeting mesothelin with Currus’ BEAT bispecific antibody platform. The approach is designed to engage both CAR T cells and antigen-presenting cells, with the aim of activating CAR T cells in lymphoid tissue and addressing the immunosuppressive tumor microenvironment associated with solid tumors. Moving the process to the Cocoon Platform reduced hands-on operator time and viral vector requirements per batch, lowering two key cost drivers in autologous CAR T-cell manufacturing.
For the Phase 1 trial, CUR-001 will be manufactured on the Cocoon Platform at the Melbourne facility of Cell Therapies Pty Ltd (CTPL), an Australian contract development and manufacturing organization (CDMO) specializing in cell and gene therapies. Technology transfer has been completed at the facility, establishing operational readiness for clinical manufacturing.
“Getting IND clearance was a significant step forward. Ensuring we can make CUR-001 reliably, patient after patient, is now our focus. Octane and Currus plan to continue working together as CUR-001 progresses through Phase 1 and later-stage trials, with the aim of maintaining a reproducible manufacturing process that can support the program’s future requirements.”
Sam Cobb, CEO of Currus Biologics
