Medisun Medical Group‘s investment in immune cell therapy – with major advance in FDA’s clinical trials

Medisun Medical Group‘s investment in immune cell therapy – with major advance in FDA’s clinical trials

Celyad completed the safety follow-up of the second does cohort of NKR-2 clinical trials and recruited the first patient in the third dose cohort

  • This trial is a dose-increasing study designed to assess the safety and feasibility of NKG2D CAR T cell therapy in patients with acute myeloid leukemia or multiple myeloma
  • The second dose of the last patient in the last dose did not report to have any dose-limited toxicity
  • The third dose (10 ˆ7 cells) of the first patient in the cohort has started the management of the cells

Belgium – Celyad (Euronext Brussels and Paris and NASDAQ: CYAD) is a leader in development industry in the engineering cell therapy and the main focus is on cardiovascular disease and tumor immunity. Celyad announced the completion of a 21
– day safe follow-up of the last patient recruited in the second cohort of the NKG2D CAR T Cell Therapy I/IIa Clinical Trial, which was used to assess the safety and feasibility of the therapy, primarily for Acute Myeloid Leukemia (AML) or Multiple Myeloma (MM).

Celyad’s Chief Executive Officer, Dr. Christian Homsy, said,” The current progress of the KG2D CAR-T Cell Therapy Phase I clinical trial is very smooth. Since the start of the trial, there have been no reports of any adverse issue. It is highly expected the patient will go through the other stages to the third cohort,
Dr. FreDeRic Lehmann, head of the immunological oncology department at Calyad added: “We are very happy that NKG2D CAR-T cell Therapy research is still encouraging to move forward steadily. It is a good start as there is no unfavorable report after the first round and the second round of the treatment. Thank you so much for the work of our specialized research staff at Dana Farber Cancer Research Laboratory to accomplish this milestone breakthrough.

NKR represents a Natural Killer Cell Receptor. NKG2D Chimeric Antigen Receptor (CAR) T cells are now called NKR-2 T Cells, and the products development is called NKR-2.

At present, CAR-T cells are genetically modified by gene vector and transfected into a single-chain antibody variable region fragment consisting of CD3zeta signal domain and one or more co-stimulatory molecules. In addition, the use of CD19 modified CAR- T cells, also received many gratifying results. These traditional methods of transformation of T cells are limited to the treatment of some types of cancer. NKR-2 was used to fuse the human Natural Killer Cell Receptor NKG2D and human CD3zeta cytoplasmic signal domain gene sequence, and the use of DAP10 as a costimulatory molecule. This new generation of carrier’s designs are more lethal to more types of tumors. Chimeric NKG2D receptor T cells recognize eight widely identified NKG2D ligands, MICA, MICB and ULBP 1-6. These ligands are expressed in a wide range of hematological and solid tumors.

Phase I clinical trials were designed to assess the safety and feasibility of NKR-2, including the clinical activity of two different hematologic indications. With the approval of the US Food and Drug Administration (FDA) and the Institutional Review Board (IRB), the safety follow-up period after transfusion treatment has been reduced to 21 days. Once the recommended dose has been determined, it is expected that in mid- 2016, we will receive the Phase I clinical trials’ first 12 patients’ data reports.