Celyad successfully completes the safety of the group for the third dose in the NKR-2 clinical trial
- The trial is a dose-increasing study. The aim is to assess the safety and feasibility of NK cell-mediated T cell therapy in patients with Acute Myeloid Leukemia or Multiple Myeloma.
- The third dose of the last patient in the last dose did not report a dose-limited toxicity
- The recruitment of the first patient of the fourth dose cohort has been carried out
Belgium – Celyad (Euronext Brussels and Paris and NASDAQ: CYAD) is a leading development of engineering cell therapy industry. The main focus is in the study of clinical programs for cardiovascular diseases and tumor immunity. Celyad today announced the completion of a 21-days’ safety testing and follow-up of the last patient recruited in the third dose cohort of the T/Ca Phase I / II, a clinical trial pf NKR-2. The clinical trial is used to assess NKG2D Chimeric antigen receptor T cell therapy in cancer on the safety and feasibility of the disease, mainly for Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM) cancer patients.
The CEO of Celyad, Dr. Christian Homsy said,
“The study is proceeding as planned, and the fourth dose level cohort study is about to start with the successful completion of the third dose level. None of the nine patients who have been treated has ever had any safety problems. We are now preparing for the next dose level study. We are looking forward to its results, and is expected to be announced in the next few months.”
Director of Immunological Oncology of Celyad, Dr. Frederic Lehmann, Ph.D. said, “We are pleased that there is no report on safety issues in the third dose trial which is the study of the increasing dose for the first time in the body. The technique is used in multiple cancer states. We are looking forward to completing the I/IIa studies, followed by the next phase of clinical development. I am grateful to our main investigators that we have the right condition to complete the fourth dose trial in mid-2016.”
About the Celyad’s NKR-T Program
NKR represents a natural killer receptor. NKG2D chimeric antigen receptor (CAR) T cells are now called NKR-2 T cells and the product development is called NKR-2.
The existing CAR-Y cells are genetically engineered using vectors, transfected with a single-chain antibody in the variable region fragment consisting of a CD3 zeta single domain and one or more co-stimulatory molecules. Unlike existing CAR-T cells, Celyad developed an immune tumor candidate NKR-2 that expresses human natural killer cell- activated receptors. Different from the traditional CAR technology, the use of natural human killer cell receptor, NKR-2 has the following potential:
- A combination of eight ligands expressed in a wide =range of hematological and solid tumors
- Identify and kill tumor cells as well as provide nutritional tumor blood vessels while NKG2D receptor ligands
- Identify and kill the tumor suppressor mechanism to prevent the tumor from escaping the body’s immune system
- Through the long-term immune memory cells induced adaptive autoimmune response, the tumor produces long-term immune effects
The technique was originally developed by Professor Charles Sentman of Dartmouth College and has been published in numerous peer-reviewed journals. The phase I clinical trial of NKR-2 has been filed with the US Food and Drug Administration (FDA). It is expected that the complete clinical data of the phase I dose trial will be available in mid-2016. The clinical trial was used to assess the safety and feasibility of NKR-2. With primary effect for some Acute Myeloid Leukemia and Multiple Myeloma patients, with secondary outcomes including clinical outcomes. With the approval by the FDA and the Institutional Review Board (IRB), the safety follow-up period after infusion treatment has been reduced to 21 days.