ImmuneOnco's Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors

ImmuneOnco’s Timdarpacept (IMM01) and IMM2510 Receive NMPA Approval for Clinical Study in Advanced Malignant Tumors

China-based ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541) has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its novel therapeutic combination. The study will evaluate timdarpacept (IMM01), an SIRPαFc fusion protein, in combination with IMM2510, a PD-L1/VEGF bispecific antibody (BsAb), with or without chemotherapy, for the treatment of advanced malignant tumors.

IMM01: A Breakthrough in CD47 Targeting
IMM01, a groundbreaking molecule targeting CD47, was discovered and developed by ImmuneOnco using its proprietary “mAb-Trap” technology platform. This innovative approach has garnered significant international recognition, as evidenced by the drug’s receipt of Orphan Drug Designation (ODD) in the US for use in combination with azacitidine in first-line CMML. This designation highlights the potential of IMM01 to address critical unmet needs in oncology.

IMM2510: Expanding Global Reach
IMM2510, also developed through ImmuneOnco’s mAb-Trap platform, represents another significant advancement in cancer immunotherapy. Last year, US-based Instil Bio Inc. (NASDAQ: TIL) entered into a licensing agreement with ImmuneOnco, securing exclusive research, development, and commercialization rights to IMM2510 outside of the Greater China region. This strategic partnership underscores the global confidence in ImmuneOnco’s innovative pipeline and its potential to impact the international oncology landscape.

Mechanism and Clinical Potential
The combination of IMM01 and IMM2510 leverages the synergistic effects of targeting multiple pathways involved in tumor progression. By simultaneously blocking CD47 and engaging the PD-L1/VEGF axis, this therapy aims to enhance the body’s immune response against tumors while potentially overcoming resistance mechanisms. The inclusion of chemotherapy in the study further underscores the aggressive approach to targeting advanced malignant tumors, which often pose significant challenges in terms of treatment resistance and patient outcomes.-Fineline Info & Tech

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