FDA News

FDA clears study of GBR 1342 for multiple myeloma

The FDA cleared Glenmark Pharmaceuticals’ investigational new drug application to initiate a phase 1 study that will evaluate GBR 1342 for treatment of patients with previously treated multiple myeloma.

GBR 1342 — based on Glenmark Pharmaceuticals’ proprietary BEAT technology platform — is designed to activate the immune system by redirecting immune cells toward tumor tissue. It simultaneously engages CD38 and the CD3 molecule on T cells.

The study will be conducted in two parts. A dose-escalation component will determine the safety profile and maximum tolerable dose. An expansion cohort treated at maximum tolerable dose will allow researchers to further investigate the safety profile and preliminary efficacy of GBR 1342 in patients with multiple myeloma who have exhausted available therapies.

“This is an exciting time for Glenmark as 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,” Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals, said in a company-issued press release. “[Although] there is still significant development ahead, these steps signify that Glenmark’s investment in discovery and development of biologics is rapidly progressing.”

The FDA cleared Glenmark Pharmaceuticals’ investigational new drug application to initiate a phase 1 study that will evaluate GBR 1342 for treatment of patients with previously treated multiple myeloma.

GBR 1342 — based on Glenmark Pharmaceuticals’ proprietary BEAT technology platform — is designed to activate the immune system by redirecting immune cells toward tumor tissue. It simultaneously engages CD38 and the CD3 molecule on T cells.

The study will be conducted in two parts. A dose-escalation component will determine the safety profile and maximum tolerable dose. An expansion cohort treated at maximum tolerable dose will allow researchers to further investigate the safety profile and preliminary efficacy of GBR 1342 in patients with multiple myeloma who have exhausted available therapies.

“This is an exciting time for Glenmark as 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,” Kurt Stoeckli, president and chief scientific officer at Glenmark Pharmaceuticals, said in a company-issued press release. “[Although] there is still significant development ahead, these steps signify that Glenmark’s investment in discovery and development of biologics is rapidly progressing.”