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Celularity's clinical trial of CYNK-001 for relapsed and refractory AML showed excellent tolerability, significant graft-versus-leukemia effects, and potential for flexible therapeutic development.
Stem cell pioneer Celularity (CELU) shared exciting results from a recent clinical trial investigating the efficacy of CYNK-001, the company's proprietary natural killer cell therapy.
The trial focused on treating patients with relapsed and refractory acute myeloid leukemia (AML) disease, who face low chances of a cure which has led to the development of a reliable gene manufacturing system that adheres to US Food and Drug Administration (FDA) regulations and produces substantial quantities of exceptional cellular products, according to CEO Robert Hariri, MD, PhD.
“If you can utilize (these placenta cells) and identify the starting point for producing cell therapy products like T cells, natural killer cells, and even mesenchymal stem cells, it gives you a great deal of flexibility in your therapeutic development strategies,” he explained.
The clinical trial demonstrated that treatment with CYNK-001 was well-tolerated by patients and exhibited no associated toxicities, even at the highest doses administered. Remarkably, the grafts showcased measurable graft-versus-leukemia effects without the need for high doses of chemotherapy commonly used in autologous transplants or the risk of graft-versus-host disease (GVHD) typically associated with standard allogeneic transplants.
“We’ve been grounded in a technology platform that is highly diversified and leverages the unique source material, the postpartum placenta, which we are credited with discovering over 20 years ago, as an ideal source of cells for the emerging therapeutic space,” Hariri said in an interview.
Additionally, the company’s manufacturing systems and the inclusion of all usable materials left in the organ for the development of cell therapy products are what sets Celularity aside.
"We want to basically combine the natural killer cells from the placenta, which are completely unmodified–these are nonengineered natural killer cells–so their natural anticancer activity is supported by lymphodepletion and administration of the supporting cytokine IL2 or IL15, gave us the answers we were looking at," Hariri said.