Drug intelligence / Profile preview

p95HER2.CAR-TECH2Me

Development stage
Phase 1
Lead developer
Vall d'Hebron Institute of Oncology
Modality
Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies
Administration
Intravenous
01

Overview

p95HER2.CAR-TECH2Me is an experimental bicistronic CAR-T cell therapy designed for the treatment of HER2-amplified solid tumors, including breast, gastric, and esophageal cancers. It employs a dual-targeting strategy: a second-generation chimeric antigen receptor (CAR) specific for p95HER2 (a tumor-specific truncated isoform of HER2) and a co-expressed, secreted bispecific T-cell engager (TECH2Me) that targets CD3 and HER2 with attenuated (medium) affinity. This design aims to overcome the limitations of targeting HER2 alone—which can cause on-target, off-tumor toxicity in normal tissues—by using the tumor-specific p95HER2 as the primary anchor and the affinity-tuned bispecific to enhance efficacy against HER2-overexpressing cells while sparing normal cells with physiological HER2 levels. Developed by the Vall d'Hebron Institute of Oncology (VHIO) in collaboration with Roche, it has demonstrated potent anti-tumor activity and complete regressions in patient-derived xenograft (PDX) models.

Other names
p95HER2-CAR-TECH2Mep-95HER2-CAR-TECH2Mep 95HER2-CAR-TECH2Mep95HER2.CAR T cells armed with HER2 x CD3 bispecific antibodiesp-95HER2.CAR T cells armed with HER2 x CD3 bispecific antibodiesp 95HER2.CAR T cells armed with HER2 x CD3 bispecific antibodies
02

Targets

p95HER2 (Human epidermal growth factor receptor 2, methionine 611 carboxy-terminal fragment)ERBB2 (Erb-b2 receptor tyrosine kinase 2)CD3 (T-cell surface glycoprotein CD3)

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