ViroCell Biologics, a viral vector Contract Development and Manufacturing Organization (CDMO), has successfully delivered a novel retroviral vector to AvenCell Therapeutics Inc. for their investigational CD19/CD20 dual-targeted cell therapy, AVC-203. The allogeneic CAR-T therapy is designed to treat B cell malignancies and autoimmune diseases, with a phase I clinical trial for relapsed/refractory B cell lymphoma planned for the second half of 2025.
Novel Allogeneic CAR-T Platform
AVC-203 represents AvenCell's second investigational "off-the-shelf" CAR-T product, engineered to address critical limitations of current CAR-T therapies. The therapy is specifically designed to mitigate graft-versus-host disease and graft rejection by host T and Natural Killer cells, potentially offering significant advantages over existing treatments.
The therapy incorporates AvenCell's proprietary RevCAR receptor technology, which enables additional antigen targeting with in vivo "off/on" capability beyond the primary CD19 and CD20 targets. This innovative approach aims to deliver improved efficacy, immediate treatment availability, and reduced cost compared to existing CAR-T therapies.
Manufacturing Partnership
ViroCell was selected for this collaboration based on its expertise in high-yield vector production and ability to meet accelerated development timelines. The company successfully integrated AvenCell's acquired cell line into its Good Manufacturing Practice (GMP) manufacturing process to deliver the complex retroviral vector critical to the AVC-203 program.
"We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform," said John W. Hadden II, CEO of ViroCell Biologics. "I am proud of Team ViroCell's accomplishments on the successful end-to-end delivery of this retroviral vector and accelerating a novel therapy into clinical development in an area of high unmet need."
Clinical Development Timeline
The successful delivery of the retroviral vector supports AvenCell's clinical development timeline, with AVC-203 expected to enter phase I trials in relapsed/refractory B cell lymphoma patients in the second half of 2025. The therapy's allogeneic nature is designed for rapid administration and broader patient access compared to autologous CAR-T approaches.
Andrew Schiermeier, Ph.D., CEO of AvenCell, expressed satisfaction with the partnership: "We are delighted with ViroCell's performance in process development and GMP manufacture of this complex retroviral vector. We selected ViroCell to support our platform because we knew that they could execute reliably in areas where other CDMOs can't."
Strategic Implications
The collaboration highlights the growing demand for scalable CAR-T therapies and demonstrates the importance of advanced CDMO partnerships in accelerating therapeutic development. The partnership positions both companies to advance innovative cell therapy solutions in oncology and autoimmune disease treatment, addressing significant unmet medical needs in these therapeutic areas.
