Fc Engineered Anti-Human HER2 Therapeutic Antibody, a CDC-Enhanced Biobetter [Lot: CB20-PZ02] (CAT#: BioBet-C002ZP) Datasheet

ERBB2

erb-b2 receptor tyrosine kinase 2

This gene encodes a member of the epidermal growth factor (EGF) receptor family of receptor tyrosine kinases. This protein has no ligand binding domain of its own and therefore cannot bind growth factors. However, it does bind tightly to other ligand-bound EGF receptor family members to form a heterodimer, stabilizing ligand binding and enhancing kinase-mediated activation of downstream signalling pathways, such as those involving mitogen-activated protein kinase and phosphatidylinositol-3 kinase. Allelic variations at amino acid positions 654 and 655 of isoform a (positions 624 and 625 of isoform b) have been reported, with the most common allele, Ile654/Ile655, shown here. Amplification and/or overexpression of this gene has been reported in numerous cancers, including breast and ovarian tumors. Alternative splicing results in several additional transcript variants, some encoding different isoforms and others that have not been fully characterized.

NEU; NGL; HER2; TKR1; CD340; HER-2; MLN 19; HER-2/neu

Protein Based Therapies
Monoclonal antibody (mAb)

Whole Humanized Antibody

Trastuzumab is a chimeric mouse / human monoclonal antibody directed against the HER2 antigen found on the surface of normal and malignant B lymphocytes. It was first approved by the US FDA in 1997 as a single drug for patients with B-cell non-Hodgkin's lymphoma (NHL), but is now approved for multiple diseases. In 2018, the FDA approved Truxima, the first biosimilar drug similar to Rituxan (Trastuzumab).

Non–Hodgkin's Lymphoma (NHL)
Chronic Lymphocytic Leukemia (CLL)
Rheumatoid Arthritis (RA)
Granulomatosis with Polyangiitis (GPA)
Moderate to severe Pemphigus Vulgaris (PV) in adult patients

RHUMAB HER2
trastuzumab-anns
trastuzumab-dkst
trastuzumab-dttb
trastuzumab-pkrb
trastuzumab-qyyp

Similar to the parental antibody Trastuzumab, glycoengineered ADCC-enhancement Trastuzumab works by targeting HER2 / neu receptors on cancer cells. In the normal body, the HER2 protein receptor is displayed on the cell surface and sends signals by inducing cell division and reproduction, thus indicating normal cell growth. In some cancerous breast tissues, HER2 is excessive (HER2 / neu overexpressed), triggering excessive cell division and reproduction. Trastuzumab attaches to the HER2 receptor to inhibit cell proliferation, prevent further cancer growth and slow cancer progression. It can also work by stimulating immune mechanisms - antibody-dependent cellular cytotoxicity (ADCC).

It is suitable for treating early HER2-positive early breast cancer or metastatic breast cancer that substantially overexpresses HER2. Approved for gastric cancer, metastatic gastroesophageal junction adenocarcinoma, and metastatic adenocarcinoma of the gastro-esophageal junction, provided that these cancers overexpress HER2.