Tolerance Bio
Tolerance Bio is a biopharmaceutical company dedicated to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance. They develop thymus preservation, regeneration, and manipulation platforms to prevent and treat immune diseases, aiming to address conditions such as cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies. Their approach involves allogeneic thymus cell therapy platforms and pharmacological therapies to restore thymic function and improve immune tolerance.
Industries
Nr. of Employees
small (1-50)
Products
Allogeneic iPSC-derived thymus cell therapy platform
An off-the-shelf cell therapy platform derived from iPSC designed to preserve, restore, or manipulate thymic function to address immune-mediated diseases.
Pharmacological thymus therapies
Drug-based therapeutic candidates intended to delay or prevent thymic involution or to restore thymic function in acute or age-related contexts.
Disease-specific thymic cell preparations
Thymic cell products tailored to particular disease contexts intended to reconstitute or re-educate T cell repertoires for therapeutic benefit.
Allogeneic iPSC-derived thymus cell therapy platform
An off-the-shelf cell therapy platform derived from iPSC designed to preserve, restore, or manipulate thymic function to address immune-mediated diseases.
Pharmacological thymus therapies
Drug-based therapeutic candidates intended to delay or prevent thymic involution or to restore thymic function in acute or age-related contexts.
Disease-specific thymic cell preparations
Thymic cell products tailored to particular disease contexts intended to reconstitute or re-educate T cell repertoires for therapeutic benefit.
Services
Translational R&D and preclinical development
Preclinical program design and execution including in vitro and in vivo pharmacology, efficacy models, and biomarker identification to support candidate selection and IND packages.
CMC and manufacturing process development
Definition and development of scalable cell processing methods, process transfer toward GMP, and CMC strategy for cell therapy products.
Regulatory strategy and submission support
Regulatory planning and strategy for biologics and cell therapies, including regional regulatory interactions and preparation for IND/BLA activities.
Assay development and bioanalytical services
Development and validation of flow cytometry panels, qPCR assays, and cytotoxicity assays to support R&D, QC, and release testing.
Translational R&D and preclinical development
Preclinical program design and execution including in vitro and in vivo pharmacology, efficacy models, and biomarker identification to support candidate selection and IND packages.
CMC and manufacturing process development
Definition and development of scalable cell processing methods, process transfer toward GMP, and CMC strategy for cell therapy products.
Regulatory strategy and submission support
Regulatory planning and strategy for biologics and cell therapies, including regional regulatory interactions and preparation for IND/BLA activities.
Assay development and bioanalytical services
Development and validation of flow cytometry panels, qPCR assays, and cytotoxicity assays to support R&D, QC, and release testing.
Expertise Areas
- Cell therapy development
- Regenerative medicine focused on thymus biology
- Clinical trial design and first-in-human studies
- CMC and cell manufacturing strategy
Key Technologies
- Induced pluripotent stem cell (iPSC) differentiation
- Thymic epithelial cell implants
- Bioengineered thymic organoids
- Cell therapy manufacturing (GMP/cGMP)