Drug intelligence / Profile preview

disitamab vedotin + PD-L1 inhibitor + GM-CSF + thymopentin

Development stage
Unknown
Lead developer
RemeGen
Modality
Peptides, Cytotoxic ADCs → Antibody-Drug Conjugates (ADCs) → Antibody Conjugates → Antibody-Based Therapeutics, Monoclonal Antibodies → Antibody-Based Therapeutics, Cytokines & Interferons → Recombinant Proteins and Enzymes
Administration
Intravenous, Subcutaneous, Intramuscular
01

Overview

ADC + PD-L1 + GM-CSF + thymopentin is a multi-component combination immunotherapy regimen evaluated in the PRaG9.0 Phase II clinical trial (NCT06112041) for elderly patients with HER2-positive advanced solid tumors. The regimen consists of the HER2-targeting antibody-drug conjugate (ADC) disitamab vedotin (RC48), a PD-L1 checkpoint inhibitor, the immunostimulatory cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF), and the synthetic immunomodulatory peptide thymopentin. This regimen is an extension of the PRaG platform therapy, which typically incorporates hypofractionated radiotherapy to induce an in-situ vaccine effect. The combination is designed to provide targeted cytotoxic delivery to HER2-expressing tumor cells while simultaneously stimulating a systemic anti-tumor immune response through checkpoint blockade and immune effector cell activation.

Other names
PRaG 9.0 regimenPRaG9.0 regimenPRaG-9.0 regimenRC48 + PD-L1 inhibitor + GM-CSF + thymopentin
02

Targets

CSF2RB (Cytokine receptor common subunit beta)ERBB2 (Erb-b2 receptor tyrosine kinase 2)CD274 (Programmed cell death protein 1 ligand 1)TUBB (Tubulin (alpha and beta subunits))

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