First Patient Dosed With CYAD-211, a Potential CAR T-cell Therapy

First Patient Dosed With CYAD-211, a Potential CAR T-cell Therapy
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The first patient has been dosed in Celyad Oncology’s Phase 1 clinical trial evaluating CYAD-211, an investigational donor-derived CAR T-cell therapy for treating relapsed or refractory multiple myeloma.

The IMMUNICY-1 trial (NCT04613557) intends to recruit 12 patients who received two or more prior lines of treatment, including an immunomodulatory agent and a proteasome inhibitor. Enrollment is ongoing in Belgium and the U.S.

“Dosing the first patient with CYAD-211 marks another major milestone to systematically advance our pipeline of non-gene edited allogeneic CAR T candidates,” Frédéric Lehmann, MD, vice-president of clinical development and medical affairs at Celyad Oncology, said in a press release.

“Enrollment in the IMMUNICY-1 trial will continue over the coming months and we expect to report proof-of-concept data from the initial dose cohorts [groups] of the trial during the first half of 2021,” Lehmann added.

Celyad is focused on the discovery and development of chimeric antigen receptor T-cell therapy, or CAR T-cell therapy, in which T-cells (a type of immune cell) are collected and genetically engineered to target and eliminate specific cancer cells.

CYAD-211 is an investigational donor-derived (allogenic) CAR T-cell therapy in which T-cells are modified to target the B-cell maturation antigen (BCMA), a protein that is highly produced by myeloma cells.

A second component of this investigational treatment is a short hairpin RNA (shRNA) that aims to reduce a specialized protein receptor that occurs naturally in T-cells — the T-cell receptor (TCR) — and helps these cells recognize their targets during an immune response.

While CYAD-211’s first component seeks to make the therapy an effective treatment for myeloma, the second seeks to reduce the risk of graft-versus-host disease, a potentially life-threatening condition in which donor immune cells attack the patient’s healthy tissue.

“BCMA is highly expressed in multiple myeloma patients and we hope to see a positive clinical benefit with our approach of targeting BCMA with our first-in-class CAR T which is underpinned by our shRNA technology,” Lehmann said.

IMMUNICY-1 is an open-label, dose-escalation study testing the safety and clinical activity of a single CYAD-211 infusion in adults with myeloma who have relapsed from or are refractory (resistant) to standard therapy.

Before receiving CYAD-211, patients undergo a chemotherapy regimen — consisting of fludarabine and cyclophosphamide — that aims to eliminate existing cancer cells and to create room for the modified T-cells.

Participants then will receive ascending doses of CYAD-211, ranging from 30 to 300 million cells, to determine the most effective and safest dose for further trials.

“We are proud to participate in the IMMUNICY-1 trial which will evaluate CYAD-211 in the treatment of relapsed or refractory multiple myeloma patients,” said Sébastien Anguille, PhD, a CAR-T specialist at the Antwerp University Hospital.

“Based on the encouraging preclinical data, we believe this new allogeneic CAR T targeting BCMA has the potential to become an important therapy for such a challenging patient population,” Anguille said.

Celyad also received additional €3.4 million (about $4.1 million) in funding from SPW-Recherche of the Walloon Region, Belgium, in the form of recoverable cash advances, for the development of CYAD-211.

Diana holds a PhD in Biomedical Sciences, with specialization in genetics, from Universidade Nova de Lisboa, Portugal. Her work has been focused on enzyme function, human genetics and drug metabolism.
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Inês holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Ciências e Tecnologias and Instituto Gulbenkian de Ciência. Inês currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.
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Diana holds a PhD in Biomedical Sciences, with specialization in genetics, from Universidade Nova de Lisboa, Portugal. Her work has been focused on enzyme function, human genetics and drug metabolism.
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