Policy & Regulation
First Patient Dosed in Phase 1 Clinical Trial with CART-TnMUC1
23 January 2020 - - US-based biotherapeutics company Tmunity Therapeutics, Inc has dosed the first patient in its Phase 1 CART-TnMUC1-01 clinical trial with the Tn/STn glycoform of mucin 1 (TnMUC1) chimeric antigen receptor T-cell (CAR-T) therapy in patients with TnMUC1-positive advanced cancers, the company said.

This is a first-in-human trial with a CAR-T therapy targeting this antigen.

The CART-TnMUC1 therapy was developed by a University of Pennsylvania team led by Avery D. Posey, PhD, an assistant professor of pharmacology and a member of Penn's Abramson Cancer Center.

The MUC1 glycoprotein is a transmembrane epithelial mucin normally expressed on the apical surface of most simple glandular epithelial cells.

In tumors that arise from these cells, an alternate form of MUC1 is frequently overexpressed on the cancer cell surface. The alternate form, known as TnMUC1, is depolarized and aberrantly glycosylated.

Tmunity's cell therapy specifically targets the Tn (GalNAca1-O-Ser/Thr) and sialyl-Tn (NeuAca2-6-GalNAcal-O-Ser/Thr) glycoforms of MUC1 with a fusion protein recognizing a short peptide sequence with one or two Tn O-glycans on the Ser/Thr residues.

Tmunity's CAR-T therapy also contains within its construct a novel co-stimulator region known as CD2.

The CART-TnMUC1-01 study is a Phase 1 trial evaluating the investigational product CART-TnMUC1 in patients with TnMUC1 positive refractory tumors in combination with a lymphodepletion chemotherapy regimen.

The primary objective of the trial is to establish safety and the recommended Phase 2 dose of CART-TnMUC1 that can be administered with lymphodepletion.

The trial is currently open to patients with TnMUC1-positive, treatment-resistant solid tumors, including: metastatic ovarian cancer (including cancers of the fallopian tube), pancreatic ductal adenocarcinoma, hormone receptor -negative and HER2-negative (triple negative) breast cancer and non-small cell lung cancer.

Tmunity is a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T-cell immunotherapy to patients with devastating diseases.

Integrating a foundational collaboration with the University of Pennsylvania with the groundbreaking scientific, clinical, and manufacturing expertise, and the demonstrated track record of its founders (Carl June, MD; Bruce Blazar, MD; Bruce Levine, PhD; Yangbing Zhao, MD, PhD; Jim Riley, PhD; and Anne Chew, PhD), Tmunity represents a new center of gravity in translational T-cell medicine.

Through the University of Pennsylvania, the Parker Institute for Cancer Immunotherapy and other collaborations, the company is developing a diversified portfolio of novel treatments that exhibit best-in-class control over T-cell activation and direction in the body, with a focus in cancer and three programs currently in clinical development.

With headquarters in Philadelphia, Tmunity utilizes laboratories and production facilities at Penn and its own dedicated cGMP manufacturing facility in East Norriton, PA, to pursue process improvement and production scale-up in support of clinical development of its T-cell therapies.
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