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3D engineered scaffold for large-scale Vigil immunotherapy production.

Fabienne Kerneis1, Ernest Bognar1, Laura Stanbery1

  • 1Gradalis, Inc, Dallas, TX, 75006, USA.

Scientific Reports
|July 5, 2024
PubMed
Summary

Engineered extracellular matrix scaffolds successfully expanded human colorectal cancer cells (CCL-247). Expanded cells met clinical release criteria for Vigil manufacturing, supporting further clinical development.

Keywords:
Autologous tumor cell therapyCell expansionImmunotherapyOvarian cancerVigil

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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.