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  • Glenmark Gets CDSCO...

Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-28T18:00:44+05:30  |  Updated On 21 March 2024 9:24 PM IST
Glenmark Pharma USA launches Epinephrine Injection

Glenmark Pharma USA launches Epinephrine Injection

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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.

Also Read:GSK gets CDSCO Panel Nod To study Anti-cancer Drug Belantamab mafodotin

glenamrkcdscoanticancer drugISB 2001multiple myelomarelapsed or refractory multiple myeloma
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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