ImmunoACT’s cell therapy to treat blood cancer gets CDSCO nod

ImmunoACT’s cell therapy to treat blood cancer gets CDSCO nod

Subject :Science and Tech

Section: Biotechnology

Context:

IIT Bombay-incubated Immunoadoptive Cell Therapy (ImmunoACT), in which drugmaker Laurus Labs holds about 34% stake, has received Central Drugs Standard Control Organisation’s (CDSCO) marketing authorisation approval of the ‘first’ humanised CD19-targeted Chimeric Antigen Receptor T cell (CAR-T cell) therapy product for relapsed/refractory B-cell lymphomas and leukaemia (blood cancer) in India.

India’s homegrown CAR-T cell therapy, a form of immunotherapy, gets market authorisation

DEATAILS:

• For treating relapsed-refractory B-cell lymphoma and leukemia, Mumbai-based Immunoadoptive Cell Therapy Private Limited (ImmunoACT) announced the approval of India’s first chimeric antigen receptor (CAR) T-cell therapy by the Central Drugs Standard Control Organization (CDSCO) on October 13, 2023.
• Called NexCAR19, it is an indigenously developed CD19-targeted CAR-T cell therapy.
• CD-19 is biomarker for B lymphocytes and can be utilised as a target for leukemia immunotherapies.
• ImmunoACT is an IIT Bombay-incubated company founded in 2018 and works on converting research into pharmaceutical products
• It is a major breakthrough as the therapy is not available in India outside of clinical trials.
• The multi-centre Phase I and II clinical trials were conducted with 60 patients with r / r B-cell lymphomas and leukemia. The clinical data indicated a 70 per cent overall response rate.
• ImmunoACT received market authorisation for our CAR-T cell therapy from the Drugs Controller General of India .
• CAR T-cell therapy is generally accompanied by some side effects. One of them, according to the American Cancer Society, is cytokine release syndrome (CRS). It is when CAR T-cells multiply, they can release large amounts of chemicals called cytokines into the blood, which can ramp up the immune system.
• In comparison to other CAR T-cell therapies, the safety profile of CRS and the absence of neurotoxicity indicates a significant improvement.
• Priorly, CAR-T cell therapy cost around $400,000 or over Rs 3.3 crore and patients could avail of it in the United States. With this development, the therapy will be accessible at 20 Indian government and private hospitals treating cancer across major cities at around Rs 30-35 lakh per patient.

About CAR-T Cell Therapy 

• CAR-T cell therapy stands for chimeric antigen receptor T cell therapy.
• It is a type of cancer immunotherapy that uses the patient’s own T cells, genetically modified in a laboratory to enhance their ability to locate and destroy cancer cells.

Working Process

• T cells are white blood cells responsible for identifying and fighting illness and infection.
• Each T cell has a receptor that can recognize antigens (proteins or molecules recognized by the immune system).
• Cancer cells may have antigens that the immune system does not recognize as abnormal, allowing cancer to evade the immune response.
• CAR-T cells are genetically engineered in the lab to express a new receptor that can bind to cancer cells and effectively kill them.
• The process involves several steps, including:

1. Collecting T Cells: Blood is drawn from the patient’s arm, and T cells are separated from the blood using an apheresis machine.
2. Engineering T Cells: In a laboratory, the T cells are modified by adding a manufactured CAR, and they are allowed to multiply and grow.
3. Infusing CAR-T Cells: Once enough CAR-T cells are prepared, they are injected back into the patient’s arm.

• Chemotherapy may be recommended before CAR-T cell infusion to enhance treatment effectiveness.
• The process can take place in an outpatient infusion center or a hospital setting.

Cancers Treated:

• CAR-T cell therapy is effective against certain types of cancer, especially when other treatments are ineffective.
• It is currently FDA-approved for treating haematological malignancies, including leukemia, lymphoma, and multiple myeloma.