Green Cross Cell Seeks FDA approval for CAR-T therapy against pancreatic cancer
Korean company Green Cross Cell (GC Cell) has announced plans for seeking USFDA approval for its CAR-T treatment targeting mesothelin (MSLN-CAR-T). The newly developed treatment is to help pancreatic cancer patients with a modified self-derived T cell recognizing mesothelin protein overexpressed by tumor cells.
Chimeric antigen receptor-T cell (CAR-T) therapy is a breakthrough in cancer treatment, which combines patients’ T cell and specific antigen-binding ligands to generate T cells specifically attacking tumor cells. The first CAR-T therapy was approved in 2017 targeting CD19 to cure acute lymphoblastic leukemia. Due to the high ratio of cancer-free patients post-treatment, CAR-T therapy is beginning to impact cancer research worldwide. However, it is most effective against blood cancers and not solid tumors which lack specific antigen targets and possess a more suppressive environment for immune cells.
GC Pharma was established in 1989 and focuses on plasma and cell-related researches. It expands its business into more specific fields with affiliations such as GC Cell, which specializes in cell and immunotherapies. After the approval of its autologous activated T-cell product, Immuncell-LC for hepatocellular carcinoma and glioblastoma in Korea, GC Cell applied its expertise in immunology to provide anti-mesothelin CAR-T treatments for solid cancers. Mesothelin is usually few in number in the cavity or organelles but is overexpressed by pancreatic cancers (80~85%), mesotheliomas (85~90%), ovary cancers (60~65%), non-small cell lung cancers (60~65%), making it a good target for combating solid tumors.
Experiments with orthotopic pancreatic carcinoma mouse models overexpressing MSLN showed that there’s 80~90% of tumor suppression effect after a single treatment of intraperitoneal or intravenous injection of MSLN-CAR-T, and 100% of complete response after the second injection. So far, the preclinical results have demonstrated the specificity of the CAR-T cells to MSLN expressing tumors that overcome the long-term obstacle in treating solid tumors with CAR-T therapy. Another major difficulty in treating solid tumors is the efficacy to migrate and penetrate the connective tissue and its surrounding micro-environments to the tumor site. This was also proved to be treated by MSLN-CAR-T with its 100% complete response rate. And long-term persistence was confirmed 12 weeks after experiments, implying the potential of the treatment.
GC Cell has planned to enter phase I trial in 2021 after confirming the efficacy of MSLN-CAR-T treatment in phase III trial and established a subsidiary in the US, NOVACEL Inc. in preparation for future production and selling to the American and European markets. Meanwhile, at the briefing, the company revealed its plan on conducting clinical trials for the approval of Immuncell-LC in the US. A cGMP qualified CMO company was relied on to produce the clinical drugs and the data from phase III clinical trials performed in Korea and the safety data of more than 5,000 patients administrated with the product over the past 10 years would all be filed to meet the requirement of the FDA. The CEO of GC Cell, Lee Sang-joo said: “For the better development of the group, expanding overseas is no longer a choice but an inevitable step and we’ll pay every effort improving ourselves so as to lead a role in the industry of cell therapy.” The pipeline will be further extended to treat mesothelioma and ovarian cancer as well as the combination study of MSLN-CAR-T and PD-1 immune checkpoint inhibitors. The 3rd and 4th generation MSLN-CAR-T with improved efficacy is also being studied.
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