Recombinant Human ME20M protein

ME20M is a recombinant protein-based therapeutic candidate developed for targeted cancer immunotherapy, particularly in the context of melanoma and neuroblastoma. It is derived from a murine monoclonal antibody (mAb) that specifically recognizes the disialoganglioside GD2. a tumor-associated antigen overexpressed on the surface of certain cancers. To reduce immunogenicity and enhance clinical applicability, the original murine antibody was humanized through genetic engineering, resulting in a chimeric antigen receptor (CAR) or single-chain variable fragment (scFv) design.

The ME20M protein typically combines the antigen-binding domain (scFv) of the anti-GD2 antibody with intracellular signaling domains, such as CD28 or 4-1BB, to activate T cells upon antigen recognition. This design enables engineered T cells (CAR-T cells) to selectively target GD2-positive tumors, triggering cytotoxic responses while sparing healthy tissues with low GD2 expression. Preclinical studies demonstrated its ability to induce tumor regression in xenograft models and enhance T-cell proliferation and cytokine secretion.

Clinically, ME20M gained attention as part of early-phase trials (Phase I/II) evaluating GD2-targeted CAR-T therapies. In neuroblastoma, GD2-targeting approaches showed partial responses and prolonged survival in refractory cases. For melanoma, ME20M-based constructs aimed to address high relapse rates post-standard therapy. Challenges include managing on-target/off-tumor toxicity due to GD2's limited expression in neural tissues and optimizing CAR-T persistence. Recent iterations focus on combining ME20M-derived CARs with checkpoint inhibitors or cytokine support to improve efficacy. Its development reflects broader efforts to expand CAR-T applications beyond hematologic malignancies into solid tumors.