(Health Korea News / Lee Chung-man) There is a growing possibility that Curocell’s ‘CRC01’ (Anbalcell) will win the title of the first domestically produced chimeric antigen receptor T (CAR-T, Chimeric Antigen Receptor-T) cell therapy.
On the 7th, the Ministry of Food and Drug Safety approved the use of ‘CRC01’ as a therapeutic drug for individual patients with systemic lupus erythematosus. The applicant for approval for use is Seoul St. Mary’s Hospital of the Catholic University of Korea, and the hospital plans to use ‘CRC01’ for individual patient treatment.
Previously, the Ministry of Food and Drug Safety approved the use of ‘CRC01’ for treatment purposes for the first time in October 2021. This is the first approval received this year and the seventh overall.
Considering that ‘CRC01’ has not yet been approved in Korea and clinical trials have not been conducted in Korea, it is interpreted that the Ministry of Food and Drug Safety has recognized the clinical usefulness of ‘CRC01’.
The difference becomes even more evident when compared to AbClone’s ‘AT101’. ‘AT101’ and ‘CRC01’ are currently being evaluated in phase 2 and are competing for development for the title of the first domestic CAR-T cell therapy, but ‘AT101’ has never been approved for use for therapeutic purposes.
Therefore, since ‘CRC01’ has secured more efficacy data than ‘AT101’, it is expected to be more advantageous in obtaining approval from the Ministry of Food and Drug Safety in the future.
As if to prove this, the Ministry of Food and Drug Safety designated ‘Anbalcell’ as a target of the advanced biopharmaceutical expedited processing system on August 7 this year.
The advanced biopharmaceutical expedited processing system is a law designed to quickly launch highly innovative medicines, such as treatments for life-threatening diseases or serious diseases, to the market and support rapid supply to patients.
With this designation as a target for expedited processing, Anvalcell will be able to receive a prompt review with priority over other products as a dedicated staff will be formed to review new drug approvals. In addition, you can also receive the benefit of being exempted from some of the customized screening and clinical trial data that reviews the prepared data of the approval applicant. Based on these benefits, the processing deadline under the Ministry of Food and Drug Safety product approval regulations will be shortened from 120 business days to 90 business days.
‘Anbalcell’ is called a ‘miracle anti-cancer drug’ or ‘one-shot treatment’ because it can be expected to completely cure blood cancer with just one administration.
CAR-T cells can proliferate on their own in the patient’s body, and when they come into contact with cancer cells, their activity is further strengthened and they continuously track and attack cancer cells. This allows the body to completely eliminate cancer cells.
However, the therapeutic activity of CAR-T cells may be reduced due to immune checkpoint proteins that inhibit the immune response in the body. Representative immune checkpoint proteins are PD-1 and TIGIT, and these proteins maintain homeostasis in the body by suppressing the activity of immune cells, including CAR-T cells.
Accordingly, the industry is attempting to develop a treatment that further improves the efficacy of CAR-T cells by combining CAR-T cell therapy with immune checkpoint inhibitors. However, there is no CAR-T treatment + immune checkpoint inhibitor combination therapy that has yet been approved by regulatory authorities.
‘Anbalcell’ is attracting attention as an innovative new drug that can solve these problems at once. This is because this drug targets PD-1 and TIGIT in addition to CD19, a protein on the surface of B cells, which is the main cause of blood cancer.
In particular, ‘Anvalcell’ is currently the only CD19+PD-1+TIGIT CAR-T treatment. Novartis’ Kymriah (ingredient name: tisagenlecleucel), which appeared as the first CAR-T cell therapy in August 2017, targets only CD19.
‘Anvalcell’ actually demonstrated better therapeutic effects than existing CAR-T cell treatments in clinical trials. According to the company, while existing CAR-T treatments show an 80% effectiveness in acute leukemia, they show a relatively low effect of 50% in chronic leukemia or lymphoma, but ‘Anvalcell’ showed consistent therapeutic effects regardless of disease.
Based on this, Curocell plans to apply for permission for ‘CRC01’ from the Ministry of Food and Drug Safety in the first half of next year. Accordingly, unless there are any major problems, ‘CRC01’ is expected to obtain approval in the second half of next year.
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