September 24, 2021

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Gavo-cel received FDA orphan drug designation for cholangiocarcinoma

Gavo-cel received FDA orphan drug designation for cholangiocarcinoma.  

Gavo-cel received FDA orphan drug designation for cholangiocarcinoma



Gavo-cel received FDA orphan drug designation for cholangiocarcinoma.  

On September 2, 2021, TCR2 Therapeutics Inc. announced that the US Food and Drug Administration (FDA) has granted Gavocabtagene autoleucel (gavo-cel; TC-210) Orphan Drug Designation (ODD) for the treatment of cholangiocarcinoma .

Gavo-cel is a new type of cell therapy consisting of autologous genetically engineered T cells expressing a single domain antibody that recognizes human mesothelin and is fused to the CD3-ε subunit, which is integrated into the endogenous after expression Sex T cell receptor (TCR) complex.

The new clinical data from the dose escalation part of the Phase 1/2 clinical trial of Gavo-cel for the treatment of patients with refractory mesothelin-expressing solid tumors will be highlighted as part of the oral report of the 2021 ESMO conference. The study will include Gavo-cel in Data in malignant mesothelioma, ovarian cancer, and cholangiocarcinoma. At that time, Tumor Jun will also bring readers the sharing of the latest data.

Gavo-cel received FDA orphan drug designation for cholangiocarcinoma

(Picture from ESMO official website)

Gavo-cel received FDA orphan drug designation for cholangiocarcinoma

(The picture is from the official website of TCR2)

Solid tumors expressing mesothelin

Mesothelin is a cell surface glycoprotein that is highly expressed in a variety of solid tumors, including malignant pleural/peritoneal mesothelioma, ovarian cancer, cholangiocarcinoma, breast cancer, and pancreatic cancer. Since mesothelin plays an active role in malignant transformation and tumor invasion by promoting the proliferation, invasion and metastasis of cancer cells, the overexpression of mesothelin is related to the poor prognosis of certain cancers. In the United States alone, among various solid tumors expressing mesothelin, non-small cell lung cancer, ovarian cancer, mesothelioma and cholangiocarcinoma have as many as 80,000 patients each year.

(source:internet, reference only)


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