Ever Supreme Bio Technology announced on the 25th that it has initiated patient recruitment for Phase I/IIa clinical trials of its allogeneic CAR-T therapy, CAR001, targeting colorectal cancer, malignant brain cancer, breast cancer, and lung cancer. This new drug has not only received guidance as a priority project from the Center for Drug Evaluation (CDE) but is also actively negotiating licensing agreements with international pharmaceutical companies to expand the global market for CAR001.
According to Ever Supreme Bio Technology, CAR001 is one of the few off-the-shelf therapies that targets both HLA-G and PD-L1, utilizing bispecific T-cell engager (BiTE) technology. This approach enlists bystander T cells to jointly combat solid tumors. In animal models of solid tumors, CAR001 has shown impressive results, eradicating nearly 90% of tumors. These findings have been published in the prestigious journal, *Advanced Science*.
General Manager Wen-Liang Huang stated that Ever Supreme Bio Technology is the world's first company to use AI to identify the HLA-G target for CAR-T technology. The company has received approval from both the US FDA and Taiwan's TFDA to proceed with Phase I/IIa clinical trials. They have started recruiting patients with colorectal cancer, malignant brain cancer, breast cancer, and lung cancer.
In addition to the progress with CAR001, Ever Supreme Bio Technology has established a joint venture with biotech companies from North America to develop a series of allogeneic umbilical mesenchymal stem cell (UMSC01) products. These products have received approval from the FDA and TFDA to conduct clinical trials, with the fastest progress seen in a Phase IIa trial for acute myocardial infarction.
Despite angioplasty and medication, approximately 20% to 40% of acute myocardial infarction patients develop heart failure, which has a five-year survival rate of about 50%. Ever Supreme Bio Technology has successfully enrolled seven acute myocardial infarction patients in the trial, none of whom have experienced severe adverse reactions, and all have been discharged successfully.
Moreover, the Phase I/IIa clinical trial for multiple sclerosis has successfully enrolled two participants. Given the lack of effective standard treatments for multiple sclerosis, stem cell therapy is receiving significant attention.
Wen-Liang Huang highlighted that the UMSC01 treatment for acute myocardial infarction has entered Phase II clinical trials. Under the recently passed regenerative medicine legislation, treatments for life-threatening or severely disabling diseases can obtain a five-year provisional license and begin treating patients. CAR001 aims to become Taiwan's first allogeneic CAR-T therapy approved for treating solid tumors with a regenerative medicine license.
Additionally, the government has recently established a 10 billion NT cancer drug fund, including cancer drugs in the national health insurance coverage. If CAR001 receives a five-year provisional license, it will apply for the "Temporary Payment Fund for New Cancer Drugs" from the national health insurance, allowing more terminal cancer patients to receive cell therapy earlier and reduce their financial burden, bringing hope to countless patients at the end stages of cancer.
Resource (mandarin): 長聖異體CAR001治實體腫瘤 啟動Phase I／IIa臨床試驗
