Drug intelligence / Profile preview

pembrolizumab + porustobart

Development stage
Phase 2
Lead developer
Solstice Oncology
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

Keytruda + HBM4003 (pembrolizumab + porustobart) is an investigational combination immunotherapy regimen under clinical development for the treatment of advanced solid tumors, including microsatellite-stable (MSS) colon cancer and non-small cell lung cancer (NSCLC). The regimen combines pembrolizumab (Keytruda), a humanized monoclonal antibody targeting the programmed cell death protein 1 (PD-1) receptor, with porustobart (HBM4003), a next-generation, fully human heavy-chain-only monoclonal antibody targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Porustobart is engineered with an enhanced Fc region to promote the depletion of immunosuppressive regulatory T cells (Tregs) in the tumor microenvironment via antibody-dependent cellular cytotoxicity (ADCC), while pembrolizumab prevents PD-1 from binding to its ligands (PD-L1 and PD-L2) to restore T-cell activation. By simultaneously targeting these complementary immune checkpoint pathways, the combination aims to synergistically enhance anti-tumor immune responses. Solstice Oncology is developing the combination in the neoadjuvant setting for resectable stage II-III MSS colon cancer under a license from Harbour BioMed.

Other names
HBM4003 + KeytrudaHBM4003 + MK-3475HBM4003 + pembrolizumabKeytruda + HBM4003Keytruda + porustobartMK-3475 + HBM4003MK-3475 + porustobartpembrolizumab + HBM4003pembrolizumab + porustobartporustobart + Keytrudaporustobart + MK-3475porustobart + pembrolizumab
02

Targets

CTLA-4 (Cytotoxic t-lymphocyte–associated protein 4)PDCD1 (Programmed cell death protein 1 receptor)

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