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Celyad Registers First Hematological Patient in CAR-T NKR-2 THINK Trial

17/02/2017

Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of engineered cell-based therapies, today announced a further step in the CAR-T NKR-2 THINK trial with the registration of a first refractory Multiple Myeloma patient. This patient is expected to receive the first dose-level (3x108 CAR-T NKR-2 cells) in the coming weeks, opening the first cohort of the hematological arm of the study.

“Following the registration of three patients in solid indications, the THINK trial is now following on from our previous NKR-2 Phase I trial which demonstrated the safety and signs of efficacy of CAR-T NKR-2 cells in cancer patients suffering from hematological cancers,” said Christian Homsy, CEO of Celyad. “We now look forward to enrolling patients suffering from AML or MM into the hematological arm of THINK and we hope that the related results will be as encouraging as they have been so far with lower dose levels.” 

“Multiple Myeloma causes approximately 10% of all hematologic malignancies, and while efficient treatments are available, most patients will eventually relapse. Celyad has generated breakthrough preclinical data in murine models, leading to 100% long-term survival. The enrollment of a first refractory Multiple Myeloma patient demonstrates the consistency of our clinical approach and highlights the unique ability of our CAR-T NKR-2 technology to target both solid and hematological malignancies,” remarked Dr. Frédéric Lehmann, VP Clinical Development and Medical Affairs at Celyad.

About the THINK trial 

THINK (THerapeutic Immunotherapy with NKR-2) is a multinational (EU/US) open-label Phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma). 

The trial will test three dose levels adjusted to body weight: up to 3x108, 1x109 and 3x109 CAR-T NKR-2 cells. At each dose, the patients will receive three successive administrations, two weeks apart, of CAR-T NKR-2 cells. The dose escalation part of the study will enroll up to 24 patients while the extension phase would enroll 86 additional patients.

About Celyad

Celyad is a clinical-stage biopharmaceutical company focused on the development of specialized cell-based therapies. The Company utilizes its expertise in cell engineering to target severe diseases with significant unmet need, including cancer. Celyad’s Natural Killer Receptor based T-Cell (NKR-T) platform has the potential to treat a broad range of solid and liquid tumors. Its lead oncology candidate, the CAR-T NKR-2, has been evaluated in a single dose escalation Phase I clinical trial to assess the safety and feasibility of CAR-T NKR-2 cells in patients suffering from AML or MM. This Phase I study was successfully completed in September 2016. Celyad was founded in 2007 and is based in Mont-Saint-Guibert, Belgium, and Boston, Massachusetts. Celyad’s ordinary shares are listed on the Euronext Brussels and Euronext Paris exchanges, and its American Depository Shares are listed on NASDAQ Global Market, all under the ticker symbol CYAD. 

About Celyad’s NKR-T Cell Platform 

Celyad is developing a unique CAR-T cell platform, using Natural Killer Receptor (NKR) transduced on to T lymphocytes. The platform targets a wide range of solid and hematological tumors. Unlike traditional CAR-T cell therapy, which target only one tumor antigen, Natural Killer (NK) cell receptors enable a single receptor to recognize multiple tumor antigens. 

Celyad’s lead candidate, CAR-T NKR-2, is a CAR-T-Cell engineered to express the human NK receptor, NKG2D, which is an activating receptor that triggers cell killing through the binding of NKG2D to any of eight naturally occurring ligands that are known to be overexpressed on more than 80% of tumors. 

Preclinical results indicate that CAR- T NKR-2 has multiple mechanisms of actions and goes beyond direct killing by signifying that its encoded T-Cells attack the tumor cells, inhibits the mechanisms that enable tumors to evade the immune system, activates and recruits anti-tumor immune cells and disrupts the blood supply to the tumor. These mechanisms promote the induction of adaptive immunity, meaning the body develops a long-term cell immune memory against specific tumor antigens of the targeted tumor. 

In contrast to traditional CAR-T therapeutic approaches, and based on strong preclinical evidence, Celyad’s current NKR-2 program does not employ patient lymphodepleting pre-conditioning, thereby avoiding the toxicities associated with chemotherapy and allowing the immune system to remain intact. 

Celyad is developing both autologous and allogeneic CAR-T NKR-2 administrations. For autologous CAR T NKR-2, Celyad collects the patient’s own T-Cells and engineers them to express NKG2D in order to target cancer cells effectively. Celyad’s allogeneic platform engineers the T-Cells of healthy donors, that also express TCR Inhibitory Molecules (TIMs), to avoid having the engineered donor cells be rejected by the patient’s normal tissues (also called Graft vs. Host Disease). 

The preclinical research underlying this technology was originally conducted at Dartmouth College by Dr. Charles Sentman and has been published extensively in peer-reviewed publications.

 

Source: Celyad

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