WALTHAM, Mass. — Cellares and TScan Therapeutics Inc. have entered into an agreement to evaluate automated clinical manufacturing of TScan’s lead TCR-T therapy candidate, TSC-101, for patients with hematologic malignancies.
The companies said the collaboration will assess the use of Cellares’ automated Cell Shuttle and Cell Q platforms for the manufacturing and testing of TSC-101, which is being developed for patients with acute myeloid leukemia and myelodysplastic syndromes.
TSC-101 is designed to treat residual disease and prevent relapse in patients with AML and MDS undergoing allogeneic hematopoietic cell transplantation. The therapy uses a gene modification approach to engineer T cells from a healthy donor into a patient-specific cell therapy product.
TScan, a clinical-stage biotechnology company based in Waltham, said it is evaluating Cellares’ automated manufacturing platform as it prepares to advance TSC-101 toward a pivotal trial expected to begin in the second quarter of 2026.
Under the agreement, Cellares will automate the TSC-101 manufacturing and testing processes on Cell Shuttle, its end-to-end manufacturing platform, and Cell Q, its automated quality control and release testing system. The companies said the closed-system workflows are designed to reduce process variability, lower labor intensity and support consistent execution across manufacturing runs and locations.
“As we prepare for the initiation of our pivotal study of TSC-101 this quarter, we are increasing our efforts for commercial readiness. Establishing a scalable and cost-efficient manufacturing strategy is a critical component. Cellares’ fully automated Cell Shuttle platform represents a promising approach to automating and scaling cell therapy production, with the potential to reduce manual processes and eliminate capacity constraints,” said Ray Lockard, M.B.A., Chief Manufacturing and Quality Officer of TScan Therapeutics. “Through this evaluation, we aim to determine how this technology could strengthen our long-term manufacturing network and support broader patient access, supporting our goal of delivering transformative therapies to patients as efficiently and reliably as possible.”
Cellares, based in South San Francisco, describes itself as an Integrated Development and Manufacturing Organization focused on automated cell therapy manufacturing. The company said the agreement expands its work into TCR-engineered T cell therapies, adding to a portfolio that includes CAR-T cell therapies, hematopoietic stem cell programs and autologous progenitor T cell therapies.
“Patients with AML or MDS who remain at risk of relapse following transplant represent exactly the kind of underserved population that automated manufacturing was designed to reach,” said Fabian Gerlinghaus, Co-founder and Chief Executive Officer of Cellares. “Bringing automation to a late-stage program like TSC-101, with its healthy donor-derived but patient-specific manufacturing model, is the kind of challenge the Cell Shuttle and Cell Q were built for, and we believe it represents the manufacturing economics any developer will need to reach a population of this scale.”
