Drug intelligence / Profile preview

HX008 + niraparib + pyrrolitinib

Development stage
Phase 2
Lead developer
Haihe
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Small Molecules
Administration
Intravenous (HX008), Oral (niraparib, Pyrrolitinib)
01

Overview

This is a **combination investigational regimen** composed of three agents: - **HX008**, a monoclonal antibody targeting the programmed death 1 (**PD-1**) receptor for immune checkpoint inhibition - **Niraparib**, a small molecule inhibitor of **poly (ADP-ribose) polymerase (PARP)**, approved for ovarian cancer and other indications as maintenance or combination therapy - **Pyrrolitinib** (also known as pyrotinib), a small molecule irreversible inhibitor that targets **epidermal growth factor receptor (EGFR)** and **human epidermal growth factor receptor 2 (HER2)** tyrosine kinases, typically used in HER2-positive cancers The combination is under investigation predominantly in advanced or metastatic breast cancer characterized by deficiencies in DNA damage response (DDR) genes, including BRCA1/2, and potentially other solid tumors. The goal is to leverage **immune checkpoint blockade**, **DNA repair inhibition**, and **HER/EGFR pathway inhibition** for synergistic anti-tumor effects.

02

Targets

EGFR (Epidermal growth factor receptor)ERBB2 (Erb-b2 receptor tyrosine kinase 2)PARP1 (Poly (adp-ribose) polymerase 1)PARP2 (Poly (adp-ribose) polymerase 2)PDCD1 (Programmed cell death protein 1 receptor)

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