Cudarolimab Biosimilar - Research Grade

Human

TNFRSF4

>1mg/ml

IgG1 - kappa

CHO Cells

Ivuxolimab Biosimilar - Research Grade (ICH5119), Gimistotug Biosimilar - Research Grade (ICH5573), Revdofilimab Biosimilar - Research Grade (ICH5818), Rocatinlimab Biosimilar - Research Grade (ICH5828), Tavolimab Biosimilar - Research Grade (ICH5903), Telazorlimab Biosimilar - Research Grade (ICH5909), Vonlerolizumab Biosimilar - Research Grade (ICH5989)

https://www.imgt.org/mAb-DB/

ICH3002

P43489

Blue ice

This product is a research-grade biosimilar of Cudarolimab, supplied as an unconjugated, non-therapeutic analog of the originator antibody for research use only. It is not a clinical drug and is not intended for diagnostic or therapeutic use. Cudarolimab (originator code IBI101) is a fully human IgG1 (kappa) monoclonal antibody directed against OX40, also known as TNFRSF4 or CD134, corresponding to UniProt P43489. The originator was developed as an agonistic anti-OX40 immuno-oncology candidate intended to engage and stimulate the OX40 co-stimulatory receptor on activated T cells, thereby amplifying anti-tumor immune responses. This biosimilar reproduces the sequence-defined, target-directed binding properties of the originator so investigators can use it as a reference or comparator reagent in functional and in-vitro studies. It is manufactured to research-grade standards with low endotoxin and is available in bulk milligram to gram quantities suitable for characterization work, binding assays, and mechanism-of-action studies. Because it is an analog built around the OX40 target rather than a clone-defined hybridoma antibody, it is best described by its target and originator identity. This is guidance for ichorbio to review. OX40 (TNFRSF4, CD134; UniProt P43489) is a co-stimulatory member of the tumor necrosis factor receptor superfamily expressed predominantly on activated CD4+ and CD8+ T cells, and on regulatory T cells. Its ligand, OX40L (TNFSF4), is found on activated antigen-presenting cells such as dendritic cells, B cells, and macrophages. Engagement of OX40 by OX40L delivers a late co-stimulatory signal that promotes T-cell proliferation, survival, and effector cytokine production, and supports the generation and maintenance of memory T cells. OX40 signaling can also modulate regulatory T-cell activity within the tumor microenvironment. Because of this role in sustaining and expanding effector T-cell responses, OX40 is an actively pursued target for agonist antibodies in cancer immunotherapy, aiming to boost anti-tumor immunity. OX40 is a human target in this context.

ACT35 antigen, OX40L receptor, TAX transcriptionally-activated glycoprotein 1 receptor, Tumor necrosis factor receptor superfamily member 4, TXGP1L

This monoclonal antibody was purified using Protein A

Sterile, preservative-free, solution in PBS. BSA and Azide free.

This biosimilar is stable when stored at 2-8°C. For longer term storage (> 3 months) it is recommended to store this antibody at -20°C or -70°C.

Functional Assays

This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.

Products are for research use only. Not for use in diagnostic or therapeutic procedures.

3-4 weeks