Exclusive Summary

• First-in-Class (FIC) Innovation: Global first fully human mAb targeting HERV-K Env-TM, identified as a novel viral immune checkpoint that reverses immune evasion.
• Dual Potential in Oncology & Autoimmunity: Demonstrated potent therapeutic efficacy in refractory cancers (PDAC, AML) and autoimmune diseases (SLE) via unique mechanisms.
• Robust Preclinical Proof-of-Concept: Significant tumor inhibition observed in NSG mouse models and effective elimination of autoreactive immune cells via ADCC.
• versatile Platform Scalability: Derived from a unique high-capacity fully human antibody library, the binder facilitates expansion into Bispecifics, ADCs, and CAR-T/NK therapies.

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