Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma
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New Delhi: The drug major Glenmark has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the clinical study of the anticancer drug ISB 2001 in relapsed/refractory multiple myeloma.
This came after the drug major Glenmark presented Phase 1 clinical study protocol No. ISB 2001-101 version 2.0 amendment 01 dated 07/April/2023. This study is a first-in-human, Phase 1, open-label study that will evaluate the safety and anti-myeloma activity of ISB 2001 in participants with relapsed/refractory multiple myeloma.
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell. Healthy plasma cells help fight infections by making proteins called antibodies. Antibodies find and attack germs. In multiple myeloma, cancerous plasma cells build up in the bone marrow.
ISB-2001 is under development for the treatment of relapsed or refractory multiple myeloma. The drug candidate is a tri-specific monoclonal antibody, which is being developed based on TREAT (Tri-specific engagement by antibodies based on T cell receptor) technology. It acts by targeting BCMA, CD3, and CD38 and it is being developed based on BEAT platform. It is administered through the parenteral route.
ISB 2001 is a triple-target antibody, meaning the therapy has three arms — each one reaching out and interacting with a different target. Those targets are CD38, BCMA, and CD3.
CD38 and BCMA are proteins highly present at the surface of myeloma cells, while CD3 is a cell surface molecule found in T-cells, a type of immune cell with cancer-killing abilities.
By simultaneously targeting two cancer-specific proteins and a T-cell protein, the treatment candidate is expected to redirect immune cells to CD38 effectively- and BCMA-positive myeloma cells, triggering a cancer-destroying attack.
At the recent SEC meeting for oncology held on the 7th and 8th of February 2023, the expert panel reviewed the Phase I clinical study protocol No. ISB 2001-101 version 2.0 amendment 01 dated 07/April/2023.
After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.
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