· No safety issues or dose limiting toxicity reported in the first patient at the fourth dose level.
· Next patient, 11th of the trial, has been infused.
· The trial is a dose escalation study evaluating safety and feasibility of NKR-2 T-cell therapy in patients with Acute Myeloid Leukemia or Multiple Myeloma.
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, today announced the successful completion of the 21-day safety follow-up of the first patient enrolled at the fourth dose level in its Phase I/IIa clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy using T-cells engineered to express the NKG2D receptor in Acute Myeloid Leukemia and Multiple Myeloma patients. No safety issues or toxicities were reported.
Dr. Christian Homsy, CEO of Celyad: “We are pleased that no adverse safety signal has been reported. The next patient of the cohort has already been infused. We continue to accumulate evidence in this human trial consistent with our pre-clinical data that no preconditioning or lymphodepletion is required to administer these unique natural killer receptor expressing T-cells successfully”.
Dr. Frédéric Lehmann, Head of Immuno-Oncology at Celyad: “The absence of any safety or toxicity signal up to this point continues to support our belief that this unique engineered T-cell construct can be safely administered and potentially lead to a therapeutic effect providing hope to the thousands of patients who need better treatments for both AML and MM.”
About Celyad’s NKR-T Cell Platform
Celyad is developing a unique Natural Killer Receptor (NKR) based T-Cell platform to target 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, NKR-2, is a 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 NKR-2 has multiple mechanism of actions and goes beyond direct killing by signifying that its encoded T-Cells attack the tumor cells, inhibit the mechanisms that enable tumors to evade the immune system, activate and recruit anti-tumor immune cells and disrupt 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 NKR-2 administrations. For autologous 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.
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.
NKR-2 is currently being tested in a Phase I/IIa trial in acute myeloid leukemia and multiple myeloma patients. The trial is designed to assess the safety and feasibility of NKR-2, with secondary endpoints including clinical activity. Key research investigations include understanding the persistence of NKR-2 cells within the patient.
· Next patient, 11th of the trial, has been infused.
· The trial is a dose escalation study evaluating safety and feasibility of NKR-2 T-cell therapy in patients with Acute Myeloid Leukemia or Multiple Myeloma.
Mont-Saint-Guibert, Belgium - Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a leader in the discovery and development of cell therapies, today announced the successful completion of the 21-day safety follow-up of the first patient enrolled at the fourth dose level in its Phase I/IIa clinical trial evaluating the safety and feasibility of its NKR-2 T-cell therapy using T-cells engineered to express the NKG2D receptor in Acute Myeloid Leukemia and Multiple Myeloma patients. No safety issues or toxicities were reported.
Dr. Christian Homsy, CEO of Celyad: “We are pleased that no adverse safety signal has been reported. The next patient of the cohort has already been infused. We continue to accumulate evidence in this human trial consistent with our pre-clinical data that no preconditioning or lymphodepletion is required to administer these unique natural killer receptor expressing T-cells successfully”.
Dr. Frédéric Lehmann, Head of Immuno-Oncology at Celyad: “The absence of any safety or toxicity signal up to this point continues to support our belief that this unique engineered T-cell construct can be safely administered and potentially lead to a therapeutic effect providing hope to the thousands of patients who need better treatments for both AML and MM.”
About Celyad’s NKR-T Cell Platform
Celyad is developing a unique Natural Killer Receptor (NKR) based T-Cell platform to target 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, NKR-2, is a 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 NKR-2 has multiple mechanism of actions and goes beyond direct killing by signifying that its encoded T-Cells attack the tumor cells, inhibit the mechanisms that enable tumors to evade the immune system, activate and recruit anti-tumor immune cells and disrupt 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 NKR-2 administrations. For autologous 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.
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.
NKR-2 is currently being tested in a Phase I/IIa trial in acute myeloid leukemia and multiple myeloma patients. The trial is designed to assess the safety and feasibility of NKR-2, with secondary endpoints including clinical activity. Key research investigations include understanding the persistence of NKR-2 cells within the patient.
