Cell therapy weekly: dual-targeted CAR-T manufacturing
This week: ViroCell Biologics (London, UK) and AvenCell Therapeutics (MA, USA) partnered to manufacture CAR-T therapies for cancer and autoimmune diseases, Adicet Bio (CA, USA) dosed the first systemic sclerosis patient in the second cohort of its Phase I gamma delta CAR-T therapy trial, and Pluristyx (WA, USA) completed a funding round to advance its induced pluripotent stem cell (iPSC) technologies.
The news highlights:
- Manufacturing collaboration for dual-targeted CAR-T therapy
- First systemic sclerosis patient dosed in Phase I trial of gamma delta CAR-T therapy
- Pluristyx secures new funding to advance iPSC technologies
Manufacturing collaboration for dual-targeted CAR-T therapy
ViroCell Biologics and AvenCell Therapeutics have formed a manufacturing collaboration focused on developing advanced cell therapies for cancer and autoimmune diseases. This partnership has already achieved its first milestone with ViroCell successfully delivering a high-quality retroviral vector to AvenCell, for use in its investigational dual-targeted CAR-T therapy, AVC-203.
AVC-203 is an off-the-shelf cell therapy designed to target both CD19 and CD20 proteins found on B cells. It is expected to enter a Phase I trial for patients with relapsed or refractory B cell lymphoma in the second half of 2025.
Andrew Schiermeier, CEO of AvenCell, stated: “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.”
First systemic sclerosis patient dosed in Phase I trial of gamma delta CAR-T therapy
Adicet Bio has reached an important milestone in its Phase I clinical trial evaluating ADI-001 in autoimmune diseases by dosing the first systemic sclerosis patient in the second cohort of its study.
ADI-001 is an investigational allogeneic gamma delta CAR-T therapy that utilizes an anti-CD20 CAR to target and deplete B-cells. The US Food and Drug Administration (MD, USA) previously granted ADI-001 Fast Track Designation for the potential treatment of relapsed/refractory class III or class IV lupus nephritis, refractory systemic lupus erythematosus with extrarenal involvement and systemic sclerosis.
Julie Maltzman, Chief Medical Officer of Adicet Bio, stated: “There remains a critical unmet need for safe and effective treatment options to combat debilitating autoimmune diseases, including [systemic sclerosis], for which we believe ADI-001 has the potential to offer transformative benefits. We are pleased with the enrollment in our [lupus nephritis] and [systemic lupus erythematosus] cohort and look forward to sharing preliminary clinical data from the trial in the second half of 2025.”
Pluristyx secures new funding to advance iPSC technologies
Pluristyx, a company specializing in iPSC technologies, has successfully completed a new funding round led by BioLife Solutions (WA, USA) and BroadOak Capital Partners (MD, USA). This investment will support the company’s recently launched PluriForm™ kit and the expansion of its cell line inventory with new clinical-grade iPSCs featuring their proprietary technologies, FailSafe® and iACT™.
“We are incredibly excited for the successful close of this round and gratified to have industry leaders and peers validate our vision with their investment,” said Benjamin Fryer, CEO of Pluristyx. “The support from our Seattle area neighbor, BioLife Solutions, and continued support from our colleagues at BroadOak Partners will allow us to manufacture, commercialize, and distribute our innovative solutions and help our customers solve critical industry challenges.”