Korean researchers will attempt an advanced regenerative medicine approach, involving the administration of allogeneic umbilical cord blood-derived natural killer cells with inserted HER2-targeted genes, to patients with HER2 gene mutation-positive breast cancer and stomach cancer.
Following the meetings of the Advanced Regenerative Medicine and Advanced Biopharmaceuticals Review Committee held on July 24 and 31, the Ministry of Health and Welfare announced last Friday that it reviewed nine advanced regenerative medicine clinical research plans (two high-risk, five medium-risk, and two low-risk) and decided that three were appropriate, four were inappropriate, and two would be reviewed again.
The first project approved by the review committee is a high-risk clinical study targeting patients with HER2-positive breast cancer, involving the administration of genetically modified allogeneic umbilical cord blood-derived natural killer cells. This study aims to treat breast cancer using cells engineered with chimeric antigen receptor (CAR) genes that target HER2, introduced into allogeneic umbilical cord blood-derived natural killer cells.
Natural killer (NK) cells obtained from umbilical cord blood possess a high proliferative capacity, allowing for the production of large quantities of cells. This makes genetically modified umbilical cord blood-derived natural killer cells a promising new treatment option for advanced HER2-positive breast cancer, targeting the HER2 receptor.
Additionally, a high-risk clinical trial involving the administration of genetically engineered allogeneic umbilical cord blood-derived natural killer cells (AB-201) to patients with HER2-positive advanced gastric cancer and gastroesophageal junction cancer has also cleared the review committee's approval process.
This study will likely demonstrate antitumor activity against HER2-positive advanced gastric cancer/gastric-esophageal junction cancer by targeting HER2 using genetically modified, umbilical cord blood-derived natural killer cells.
Notably, the Minister of Food and Drug Safety has notified the review committee that the data submitted by researchers for two advanced regenerative medicine studies—involving the administration of allogeneic umbilical cord blood-derived natural killer cells with HER2-targeted genes to patients with breast cancer and gastric cancer—is deemed valid through expedited and combined review of high-risk clinical studies, paving the way for the studies to proceed, according to the Ministry of Health and Welfare.
Additionally, a low-risk clinical study evaluating the efficacy of administering mononuclear cells derived from the patient's own bone marrow to patients with non-ischemic dilated cardiomyopathy was approved at this review committee meeting.
This study aims to enhance cardiac function by employing a combination therapy that involves administering G-CSF (Granulocyte-Colony Stimulating Factor), a drug approved by the Ministry of Food and Drug Safety for treating blood disorders and cardiovascular diseases, in conjunction with minimally manipulated autologous bone marrow-derived mononuclear cells following pretreatment with G-CSF.