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The European Medicines Agency (EMA) granted priority medicines (PRIME) designation to Tessa Therapeutics’ CD30 targeted chimeric antigen receptor-modified (CAR) T cell therapy for patients with relapsed or refractory Hodgkin lymphoma.

UNC Lineberger’s Barbara Savoldo, MD, PhD, and Gianpietro Dotti, MD.

PRIME designation enables Tessa Therapeutics to expediate clinical development of this novel therapy, which was developed using research advances made by UNC Lineberger Comprehensive Cancer Center members Barbara Savoldo, MD, PhD, and Gianpietro Dotti, MD, when they were faculty members in the Cell and Gene Therapy Program at the Baylor College of Medicine.

EMA’s decision follows the U.S. Food and Drug Administration awarding Regenerative Medicine Advanced Therapy designation to the treatment regimen last year.

EMA based its decision on two parallel phase I/II clinical studies performed at the North Carolina Cancer Hospital, UNC Lineberger’s clinical home, and the Baylor Cell and Gene Therapy Program/Houston Methodist Hospital that demonstrated CD30 CAR-T therapy was effective for the treatment of patients with relapsed refractory Hodgkin lymphoma when combined with lymphodepleting chemotherapy. The combination approach, developed by the group at UNC-CH, has been licensed and is being developed as a novel therapeutic for patients with Hodgkin lymphoma by Tessa Therapeutics.

UNC Lineberger’s Jonathan Serody, MD.

“UNC Lineberger has quickly established itself as center of excellence in the development and delivery of cellular immunotherapy for cancer and specifically chimeric antigen receptor T-cell, or CAR-T, therapy,” said Jonathan S. Serody, MD, chief of hematology, the Elizabeth Thomas Professor of Medicine, Microbiology and Immunology and director of the UNC School of Medicine Cellular Therapy Program. “From what was once considered science fiction, we’re demonstrating that the human immune system can be re-engineered to attack a growing number of different cancers.”

UNC Lineberger recruited Savoldo and Dotti from Baylor in 2015 to lead its cellular immunotherapy program as well as continue their work developing and studying novel translational CAR-T therapies, including the CD30 CAR-T therapy for lymphoma.

UNC Lineberger is one of a select few academic centers in the United States and the only program in North Carolina with the scientific, technical and clinical capabilities to develop and deliver CAR-T immunotherapy to patients. The cellular products are made in a state-of-the art manufacturing facility four miles off campus. The cancer center currently has nine CAR-T clinical trials open and is developing new trials to treat a number of solid tumor cancers, including ovarian and head and neck cancer. It also offers patients commercially available CAR-T therapies.