GBR 1302 is a HER2xCD3 bi-specific antibody based on Glenmark’s BEAT platform.
The drug candidate has the potential to be used in the treatment of an array of cancers, including breast cancer. The company expects to secure approval to start clinical studies during this financial year.
Glenmark said GBR 1302’s mode of action is distinct from the existing HER2 targeting antibodies.
It redirects cytotoxic T cells via its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells.
If confirmed in clinical trials, GBR 1302 is expected to constitute a new treatment for HER2 positive cancers, potentially superior to the existing monoclonal antibody treatments.
Glenmark Pharmaceuticals chief scientific officer & president for biologics Michael Buschle said: "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."
The company currently has four monoclonal antibodies in the novel biologics entity pipeline with three of them in clinical development.
GBR 500 is indicated for the treatment of multiple sclerosis and other autoimmune diseases. It 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.
GBR 830 is the third antibody, which is an OX40 antagonist for autoimmune diseases. It is currently phase I clinical development.