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IM301 is a humanized monoclonal antibody that specifically targets Claudin 6 (CLDN6), a tight junction protein that is highly expressed in various solid tumors—including ovarian, endometrial, testicular, and lung cancers—while remaining virtually absent in healthy adult tissues. Developed by Integral Molecular using its proprietary Membrane Proteome Array and Shotgun Mutagenesis platforms, IM301 was engineered to achieve high affinity and exceptional selectivity, specifically to avoid cross-reactivity with the closely related Claudin 9 (CLDN9) protein, which is widely expressed in normal tissues. This high degree of specificity is achieved through a unique binding epitope involving the γ carbon of the Q156 residue on CLDN6. While IM301 has been studied as a standalone therapeutic candidate, it also serves as the critical Claudin 6-targeting arm of CTIM-76, a bispecific T-cell engager (CLDN6 x CD3) currently being advanced into clinical trials by Context Therapeutics.
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