On July 29, 2025 ViroCell Biologics ("ViroCell"), a specialist viral vector Contract Development and Manufacturing Organisation ("CDMO") for cell and gene therapy (CGT) clinical trials, reported a manufacturing collaboration with and the successful delivery of a novel retroviral vector to AvenCell Therapeutics, Inc. ("AvenCell"), a leading clinical-stage cell therapy company focused on advancing allogeneic switchable CAR-T cell therapies (Press release, AvenCell Therapeutics, JUL 29, 2025, View Source [SID1234654620]). This first retroviral vector will be used to manufacture AVC-203, an investigational CD19/CD20 dual-targeted cell therapy for the treatment of B cell malignancies and autoimmune diseases.
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AvenCell’s AV203 is its second investigational cell therapy using its differentiated allogeneic engineering to provide an "off-the-shelf" product engineered to overcome graft-versus-host disease as well as graft rejection by host T and Natural Killer ("NK") cells. AVC-203 is designed to achieve superior efficacy compared to currently-approved CAR-Ts while enabling immediate treatment and greater patient access at much lower cost and complexity. The further inclusion of AvenCell’s RevCAR receptor in AVC203 allows for additional antigen targeting (with "off/on" capability in vivo) beyond CD19 and CD20.
AvenCell selected ViroCell as its partner to manufacture the retroviral vector for this program based on the CDMO’s expertise and track record in delivering high yield vectors at speed. Incorporating a cell line acquired by AvenCell into the GMP manufacturing process, ViroCell successfully delivered a high yield vector while meeting AvenCell’s accelerated timeline. This program evidences ViroCell’s ability to deliver a bespoke, complex manufacturing process in the allogeneic CAR-T cell therapy space, ultimately, enabling AvenCell’s timelines for clinical entry. AvenCell’s AVC-203 is expected to enter a first-in-human phase I study in patients with relapsed/refractory B cell lymphoma in H2/2025.
John W. Hadden II, CEO of ViroCell, commented: "We are thrilled to partner with AvenCell and support their innovative allogeneic CAR-T therapy platform. 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. We look forward to continuing our work with AvenCell on their exciting platform."
Andrew Schiermeier, Ph.D., CEO, AvenCell, added: "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. The delivery of this retroviral vector for AVC-203 is proof that our trust in ViroCell was well placed."