구조모아 (StructureMoa)항암 chemical structure spider web
방문프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials·t½ ~7 days |
|---|---|
Overview Program | Ziihera (zanidatamab) |
Overview Company | Jazz Pharmaceuticals / Zymeworks |
Overview Modality | ANTIBODY |
Overview Target | HER2 (biparatopic) |
Overview Indication | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Data Confidence · High |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). |
Positioning Known limitation | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. |
Positioning Development positioning | Challenges the ToGA trastuzumab-chemo backbone in 1L HER2+ GEA; still the only HER2 agent with a dedicated BTC indication. |
MoA Mechanism | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. |
MoA Biomarker | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. |
PK/PD Half-life | ~7 days |
PK/PD Species | Cynomolgus monkey, Human, OS and PFS in GEA, ORR and DOR in BTC |
PK/PD Animal (cat.) | Human, NHP, In vitro |
PK/PD Experiment | pd |
Toxicology Species | Human |
Toxicology Major finding | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Toxicology CRS | N/A |
Clinical Safety signal | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Clinical Selected reported efficacy | ORR 52% |
Clinical Reported ORR | 52% |
Clinical Reported PFS | ~5.5 mo |
Clinical Reported OS | 15.54 |
Clinical Result source | HERIZON-BTC-01 (NCT04466891) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04466891 |
Preclinical Animal (cat.) | Unknown |
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | zanidatamab (Ziihera, ZW25, zanidatamab-hrii) Jazz Pharmaceuticals / Zymeworks·HER2 (biparatopic) 35 trials·t½ ~7 days |
|---|---|
Overview Program | Ziihera (zanidatamab) |
Overview Company | Jazz Pharmaceuticals / Zymeworks |
Overview Modality | ANTIBODY |
Overview Target | HER2 (biparatopic) |
Overview Indication | First-line HER2-positive gastric, GEJ, or esophageal adenocarcinoma; previously treated HER2-positive biliary tract cancer |
Overview Phase | APPROVED |
Overview Status | APPROVED |
Overview Content status | Curated Core |
Overview Data Confidence | Data Confidence · High |
Overview Development Signal | Development Signal · Established |
Overview Approval status | FDA approved |
Positioning Key differentiator | Dual-epitope binding drives receptor clustering, faster internalization, and stronger signaling blockade than either monoclonal alone. In GEA the label splits IHC 3+ (chemo doublet) from IHC 3+ or 2+/ISH+ (chemo + Tevimbra). |
Positioning Known limitation | HER2 heterogeneity, PI3K pathway activation, and bypass RTK signaling. |
Positioning Development positioning | Challenges the ToGA trastuzumab-chemo backbone in 1L HER2+ GEA; still the only HER2 agent with a dedicated BTC indication. |
MoA Mechanism | Simultaneous binding of two non-overlapping HER2 epitopes crosslinks adjacent receptors, causing receptor clustering, internalization, and degradation alongside ADCC and complement activity. |
MoA Biomarker | GEA: PATHWAY 4B5 IHC and VENTANA Dual ISH. IHC 3+ for chemo doublet; IHC 3+ or IHC 2+/ISH+ when Tevimbra is added. BTC: HER2 IHC 3+. |
PK/PD Half-life | ~7 days |
PK/PD Species | Cynomolgus monkey, Human, OS and PFS in GEA, ORR and DOR in BTC |
PK/PD Animal (cat.) | Human, NHP, In vitro |
PK/PD Experiment | pd |
Toxicology Species | Human |
Toxicology Major finding | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Toxicology CRS | N/A |
Clinical Safety signal | Embryo-fetal toxicity warning. Diarrhea, infusion-related reactions, and left ventricular dysfunction require monitoring, as with the HER2 antibody class. |
Clinical Selected reported efficacy | ORR 52% |
Clinical Reported ORR | 52% |
Clinical Reported PFS | ~5.5 mo |
Clinical Reported OS | 15.54 |
Clinical Result source | HERIZON-BTC-01 (NCT04466891) |
Clinical Program phase | APPROVED |
Clinical Trial activity | No active/completed counts |
Clinical Trial ref | NCT04466891 |
Preclinical Animal (cat.) | Unknown |
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