Octane Biotech Inc. and 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 they have successfully automated the manufacturing process for CUR-001, Currus’ lead clinical candidate, on Octane’s Cocoon® Platform. The transfer establishes a reliable, closed manufacturing process intended to support the consistent production of CUR-001 as it prepares to enter clinical development.

This milestone follows the clearance by the U.S. Food and Drug Administration (FDA) of Currus’ Investigational New Drug (IND) application for CUR-001, announced in September 2026. The clearance allows Currus to begin a first-in-human, open-label Phase 1 basket trial in patients with mesothelin-positive advanced refractory solid tumours. The first patient is expected to be dosed in early 2027.

CUR-001 is the first clinical programme from Currus’ BEAT (Bispecific Engager of Antigen-presenting cells and T cells) platform. It combines an autologous, FLAG-tagged CAR T-cell therapy targeting mesothelin with a BEAT bispecific antibody. The BEAT simultaneously engages the CAR T-cells and antigen-presenting cells, a design intended to activate CAR T-cells in lymphoid tissue and counter the immunosuppressive tumour microenvironment that has limited CAR T-cell therapy in solid tumours.

The two companies transferred the CUR-001 manufacturing process onto the Cocoon Platform, Octane’s closed, automated system for producing patient-specific cell therapies. Moving to the Cocoon significantly reduced hands-on operator time and the amount of viral vector each batch requires, two of the main cost drivers in autologous CAR T-cell manufacturing. The result is a much lower-cost process for CUR-001 that will support the programme as it advances through clinical development.

“Getting IND clearance was a significant step forward. Ensuring we can make CUR-001 reliably, patient after patient, is now our focus,” said Sam Cobb, Chief Executive Officer of Currus Biologics. “The success of an autologous therapy depends heavily on the process behind it. Moving CUR-001 onto the Cocoon gives us a consistent, closed process as we head into the clinic, and a manufacturing model that can grow with the programme.”

“Currus has a smart answer to one of the hardest problems in cell therapy, which is getting CAR T-cells to work in solid tumours,” said Louis Briggs, Vice President, Octane Biotech. “Automating CUR-001 on the Cocoon means fewer manual steps, less variability between batches and a process built to scale from Phase 1 onward. We’re proud to support Currus as CUR-001 moves toward its first patients.”

Octane and Currus will continue to work together as CUR-001 moves through clinical development, from Phase 1 into later-stage trials. The collaboration is intended to support the clinical development of CUR-001, establish a reproducible manufacturing process that can meet the programme’s future requirements, and ultimately provide a new CAR T-cell option to patients with hard-to-treat solid tumours.

For the Phase 1 trial, CUR-001 will be manufactured on the Cocoon® Platform at the Melbourne facility of Cell Therapies Pty Ltd (CTPL), Australia’s leading contract development and manufacturing organisation (CDMO) for cell and gene therapies. Technology transfer of the automated manufacturing process has already been successfully completed at the facility, establishing operational readiness to support the clinical manufacturing for this study. The programme will draw on CTPL’s experience in the GMP manufacture of autologous CAR T-cell therapies and its established cell therapy manufacturing capabilities.

 

Source: globenewswire.com

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