Glenmark anti-myeloma drug gets clinical trial nod from USFDA
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New Delhi: The United States Food and Drug Administration (USFDA) has cleared Glenmark Pharma’s investigational new drug application to initiate phase one study of GBR 1342, a humanised monoclonal antibody for treatment of multiple myeloma, the company said on Tuesday.
This is Glenmark’s second investigational new drug from its immuno-oncology portfolio to enter clinical trials. “GBR 1342 is designed to activate the patient’s immune system by redirecting immune cells towards tumour tissue, which may lead to targeted destruction of tumours.
It is based on Glenmark’s proprietary BEAT (Bispecific Engagement by Antibodies based on the T cell receptor) technology platform,” Glenmak said in a BSE filing. The first-in-human phase 1 study of GBR 1342 will enrol subjects with multiple myeloma who have exhausted available therapies.
“... our flagship biotechnology platform and antibody science are beginning to become a reality for patients now that we have a second oncology candidate entering clinical trials,” Glenmark Pharma president and chief scientific officer Kurt Stoeckli said.
“While there is still significant development ahead, these steps signify that Glenmark’s investment in discovery and development of biologics is rapidly progressing.” The study is being conducted in two parts. GBR 1342 is also being considered for the treatment of other malignancies, the company said. The stock of Glenmark was trading at Rs717.80, up 0.22%, on the BSE.