The U.S. Food and Drug Administration (FDA) has given Celyad Oncology permission to begin a Phase 1 clinical trial of CYAD-211, an investigational treatment for relapsed or refractory multiple myeloma. The trial is expected to commence by year’s end.
“The FDA’s permission to begin the Phase 1 clinical trial of our lead shRNA-based allogeneic candidate CYAD-211 is a watershed moment for our organization,” Filippo Petti, CEO of Celyad Oncology, said in a press release.
“Today’s announcement demonstrates our ability to advance in parallel multiple off-the-shelf product candidates based on differentiated non-gene edited allogeneic technologies into the clinic,” Petti said. “In addition, our team has delivered on incredible timelines for the CYAD-211 program, moving the project from concept to an effective [approval for clinical testing] in under two years.”
Celyad’s technology focuses on the development of allogenic chimeric antigen receptor (CAR) T-cells for treating cancer, an approach that uses donor-derived immune cells and engineers them to eliminate cancer more effectively.
Broadly, CAR T-cell therapy consists of immune T-cells that are isolated from the blood and modified in the lab to produce a man-made receptor called chimeric antigen receptor, or CAR. This receptor is designed to bind with high affinity to a specific cancer protein.
After being expanded to millions in the lab, the engineered T-cells are infused into a patient, where they are expected to kill cancer cells.
To date, most work involving CAR T-cells has used a patient’s own cells — that is, T-cells harvested from a person with cancer, modified and expanded in a lab, then put back into the person’s body to fight the cancer. However, this approach has numerous drawbacks, including being expensive and taking a fairly long time.
The use of allogenic cells, or donor-derived cells, could circumvent some of these drawbacks. But using allogenic cells has its own faults. Most notably, because the cells are not from the patient originally, there is the risk of graft-versus-host disease (GvHD), which is when donor immune cells attack the patient’s healthy tissue.
This process is mediated in large part by 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.
CYAD-211 is an allogenic CAR T-cell therapy with two principle components. First is a CAR receptor specific for B-cell maturation antigen (BCMA), a protein that is highly produced by myeloma cells. Second is a short hairpin RNA (shRNA), a molecule that reduces the levels of the endogenous TCR. The first component aims to make the therapy an effective treatment for myeloma, while the second seeks to reduce GvHD risk.
“We are excited to have the CYAD-211 IND in effect to initiate the Phase 1 trial by year-end 2020 for this first-in-class CAR T candidate for patients with multiple myeloma and look forward to accelerating the development of additional shRNA-based allogeneic candidates from our CYAD-200 series towards clinical trials,” Petti said.
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