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Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has completed phase 1 supporting studies and has submitted a clinical trial application to the Paul-Ehrlich Institute in Germany for a novel clinical development candidate, GBR 1302.
GBR 1302, a HER2xCD3 bi-specific antibody, is the first clinical development candidate based on Glenmark’s proprietary BEAT platform. Glenmark expects to obtain approval for the initiation of clinical studies with GBR1302 during this financial year.
GBR 1302 material for phase 1 clinical trials was manufactured in Glenmark GMP production unit in Switzerland. HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the multibillion dollar antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is implicated in breast cancer, ovarian, gastric, and certain uterine cancers.
Dr Michael Buschle, chief scientific officer & president - biologics, Glenmark Pharmaceuticals, said “We have high expectations for GBR 1302. During the preclinical characterisation of the bi-specific antibody we have discovered that GBR 1302 does not only kill trastuzumab resistant cancer cells, but also very efficiently kills cancer cells with a weak expression of HER2 against which all current HER2 targeting antibodies are not effective.”
Herceptin (trastuzumab) is indicated for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinomas.
With the addition of GBR 1302 to the pipeline, Glenmark has now four monoclonal antibodies in the novel biologics entity (NBE) pipeline with three of them undergoing active clinical development. First, GBR 500 (SAR339658, vatelizumab), a monoclonal antibody represents a first-in-class opportunity indicated for the treatment of multiple sclerosis (MS) and other autoimmune diseases. GBR 500 has been licensed to Sanofi and is in phase 2 clinical trials in the US.
The second monoclonal antibody, GBR 900 targets the TrkA receptor for chronic pain and is currently in clinical Phase 1. This project is developed under license from Lay Line Genomics SpA, an Italian based Company. Monoclonal antibodies specific for TrkA represent a first-in-class opportunity for the treatment of chronic pain, which has a high level of unmet need. The third antibody is GBR 830, a best in class OX40 antagonist for autoimmune diseases which recently entered phase I clinical development.
