Glenmark Pharmaceuticals has completed the pre-clinical evaluation for its novel bi-specific antibody GBR 1302 and filed the phase I trial application for the same with German regulatory authorities.
Glenmark Pharmaceuticals SA, a wholly-owned subsidiary of the company, has submitted a clinical trial application for GBR 1302 to the Paul-Ehrlich Institute in Germany, Glenmark Pharmaceuticals said in a statement.
GBR 1302 has the potential to be used in the treatment of a broad array of cancers, including breast cancer, and the company expects to obtain approval for the initiation of clinical studies during this financial year, it added.
“During the pre-clinical 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...,” Glenmark Pharmaceuticals Chief Scientific Officer & President — Biologics Michael Buschle said. GBR 1302 material for phase I clinical trials is manufactured at the Glenmark GMP production unit in Switzerland. The stock of Glenmark closed at Rs.1,016.30 on BSE, down 1.40 per cent on Tuesday.
