Belgian CAR-T biotech enrols first blood cancer patient in new trial

22-Feb-2017 - Last updated on 22-Feb-2017 at 13:09 GMT

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Celyad SA has enrolled the first multiple myeloma patient in a safety and tolerability trial of its CAR-T therapy.

Celyad’s Natural Killer Receptor based T-Cell (NKR-T) platform is used to create treatments for solid and liquid tumors, including acute myeloid leukemia (AML) or myeloid myeloma (MM).

Formerly known as Cardio3 Biosciences, Celyad’s lead cancer therapy – chimeric antigen receptor T-cell (CAR-T) NKR-2 – completed a Phase I trial for safety and feasibility in patients suffering from AML and MM in September.

The Belgium-based firm also has operations in Boston, Mass., entering the CAR-T space in 2015 when it acquired the oncology arm of Celdara Medical, OnCyte.

Christian Homsy, CEO of Celyad, told Biopharma-Reporter that the firm is using the UK-based contract research organisation Chiltern International Ltd to manage the Phase I THINK trial.

A total of 112 patients will be enrolled. This first patient opens the haematological arm of the study, and is expected to receive the first dose-level (3x108 CAR-T NKR-2 cells) in the coming weeks.

There are also five solid tumor types which will be addressed in THINK, including pancreatic, colorectal and ovarian cancers. Enrolment for this arm of the study started in January.

“Celyad has generated breakthrough preclinical data in murine models, leading to 100% long-term survival,” said Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad.

Making CAR-T NKR-2

CAR-T NKR-2 is an autologous cell therapy based on harvesting of donor T-cells which are then engineered to express cancer specific antigens.

The firm has previously said there is a need for automation in manufacturing cell bioreactors and equipment, and a closer relationship between cell therapy developers and manufacturers of equipment.

Homsy told us CAR-T NKR-2 is being manufactured at Celyad’s 500 sq meter GMP facility in Mont-Saint-Guibert, Belgium, with a team of 30 full-time equivalents.

From here the therapy is transported to the clinical sites in Brussels. An undisclosed cold chain courier is contracted for sites outside of Belgium, he added.

Although not yet specified, Homsy added: “[Celyad] looks forward to expanding the trial to US-based institutions.”