<div><strong>By CH Unnikrsihnan</strong></div><div> </div><div>Drug maker and researcher Glenmark Pharmaceuticals Ltd's new biological drug candidate Bi-Specific Antibody - GBR 1302 is entering Phase I trials after successfully completing its pre-clinical studies. The phase 1 trial of the new drug candidate, which has demonstrated superiority over current antibody therapies against most HER2 positive cancers, including breast cancer, is an important milestone in the research and development process and is crucial for Glenmark as its business model typically is to license out such successful molecules for premium valuation.</div><div> </div><div>Glenmark will be doing the Phase 1 trials of the new cancer drug in Germany. </div><div> </div><div>The phase 1 trial application for this antibody has been submitted to German regulatory authorities, said Glenmark Pharmaceuticals SA, a wholly owned subsidiary of Glenmark Pharma.</div><div> </div><div>GBR 1302 has the potential to be used in the treatment a broad array of cancers including breast cancer ·and could constitute an innovative treatment for HER2 positive cancers if confirmed in clinical trials. It is also potentially superior to the currently available monoclonal antibody treatments.</div><div> </div><div>Glenmark expects to obtain approval for the initiation of clinical studies with GBR1302 during this financial year. The material for the trial candidate was manufactured in Glenmark's production unit in Switzerland.</div><div> </div><div>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.</div><div>Commenting on this milestone, Glenmark's chief scientific officer and president (Biologics), Glenmark Pharmaceuticals Michael Buschle said that the company has high expectations for GBR 1302.</div><div> </div><div>"During the preclinical characterization 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," he said.</div><div> </div><div>GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells.</div><div> </div><div>HER2 positive or Herceptin (trastuzumab) resistant metastatic breast cancers and breast cancers with intermediate expression of HER2 also apply to other HER2 overexpressing cancers including; ovarian, certain uterine cancers, pancreatic cancers and bladder cancer. So the drug, if successfully developed, can also be useful treating other types of cancers.</div><div> </div><div>Glenmark's novel biologics entity pipeline with the addition of GBR 1302 has now four monoclonal antibodies with three of them undergoing active clinical development. First, GBR 500, a monoclonal antibody representing 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.</div><div> </div><div>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.</div>
