3D engineered scaffold for large-scale Vigil immunotherapy production

Area of Science:

• Oncology
• Biomaterials Science
• Cell Biology

Background:

• Previous studies demonstrated successful expansion of murine colorectal carcinoma cells (CT-26) using 3D engineered extracellular matrix (EECM) scaffolds.
• Human colorectal cancer cell line CCL-247 (HCT116) was cultured on 3D EECM and tissue culture polystyrene (TCPS) for 8 days.

Purpose of the Study:

• To evaluate the expansion efficiency of human colorectal cancer cells (CCL-247) on 3D EECM scaffolds.
• To assess the suitability of 3D EECM-expanded cells for Vigil manufacturing release criteria for clinical trials.
• To confirm the potential of 3D EECM for manufacturing cancer cell products for clinical use.

Main Methods:

• Cellular expansion of CCL-247 on 3D EECM scaffolds.
• Assay of cell growth, electroporation efficiency, and cytokine expression.
• Evaluation against Vigil manufacturing release criteria for Phase IIb clinical trials.

Main Results:

• CCL-247 cells expanded from 2.45 × 10^5 to 1.9 × 10^6 cells per scaffold using 3D EECM.
• All 3D EECM-derived cells met Vigil manufacturing release criteria, including cytokine expression.
• Successful Vigil product manufacture was achieved, meeting specifications for clinical trial release.

Conclusions:

• 3D EECM scaffolds effectively support the expansion of human colorectal cancer cells (CCL-247).
• The expanded cells satisfy critical manufacturing and clinical release criteria for Vigil therapy.
• This validates the use of 3D EECM for manufacturing cancer cell products from human tissue samples, including biopsies and ascites, for clinical development.