Ever Supreme Bio Tech announced on the 10th that its variant CAR001 (CAR-T), selected using AI, has received approval from Taiwan's Food and Drug Administration (TFDA) for Phase I/IIa clinical trials targeting HLA-G for solid tumor therapy. This new drug, CAR001, has also been guided as a key case by the Center for Drug Evaluation (CDE), accelerating its path to market.
Ever Supreme Bio Tech noted that the FDA approved the first CAR-T therapy for hematologic tumors in 2017. Internationally, the first child cured of leukemia using genetically modified cell immunotherapy was Emily Whitehead, who remains cancer-free after 11 years and entered university last year.
However, current CAR-T therapies primarily target hematologic tumors and have not been effective against solid tumors. Moreover, these therapies require the patient's own immune cells, customized over 1-2 months at a cost of approximately $400,000 per treatment. Despite these challenges, market research by Precedence Research shows that CAR-T products achieved a total sales of $8.444 billion last year, with an annual growth rate of 120%. The CAR-T market is estimated to reach $10.38 billion in 2024 and potentially $107.92 billion by 2033, with a compound annual growth rate (CAGR) of 30%. Ever Supreme Bio Tech aims to capitalize on this multi-billion-dollar market.
To address these limitations, Ever Supreme Bio Tech developed CAR001 for solid tumor therapy using allogeneic cell therapy. This new drug uses cells from healthy donors, ensuring stable quality without the need for customization. It can be mass-produced like conventional drugs, reducing costs, and allowing immediate use for terminal cancer patients.
CAR001 is globally innovative as the first CAR-T therapy to target HLA-G alongside CAR, capable of precisely targeting and killing solid tumor cells. It also features bispecific T-cell engager (BiTE) technology, recruiting bystander T-cells to combat tumors together. Unlike existing CAR-T therapies, CAR001 utilizes messenger RNA (mRNA) for genetic modification, lowering mutation risks.
Ever Supreme Bio Tech's research team used AI for HLA-G target screening, protein structure design, and optimization, enhancing CAR001's ability to overcome immune suppression in solid tumors. In animal models, CAR001 has shown promising results, eliminating nearly 90% of solid tumors, as published in the prestigious journal "Advanced Science."
CAR001 has received approval from both the US FDA and Taiwan's TFDA for Phase I/IIa clinical trials. This historic approval from Taiwan is expected to draw global attention, and Ever Supreme Bio Tech is actively negotiating licensing agreements with international pharmaceutical companies. This breakthrough in allogeneic CAR-T cell therapy marks a new era in solid tumor treatment, with recruitment underway for colorectal cancer, malignant brain tumors, triple-negative breast cancer, and non-small cell lung cancer trials.
Under Taiwan's Regenerative Medicine Promotion Law, CAR001, targeting critically ill cancer patients, may qualify for a five-year temporary drug license upon completion of Phase II clinical trials demonstrating safety and preliminary efficacy. Ever Supreme Bio Tech's CAR001 aims to become Taiwan's first Regenerative Medical Product certified for allogeneic CAR-T therapy for solid tumors, potentially allowing earlier access to cell therapy for numerous cancer patients, offering hope where none existed before.
Resource (mandarin): 長聖全球首例以AI進行新藥CAR-T篩選 獲TFDA核准臨床
