Glenmark initiates IND‐enabling studies of bispecific monoclonal antibody targeting EGFR

GBR 1372 is the third bispecific antibody and also Glenmark’s third clinical candidate targeting an oncology indication

Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals India, has announced the discovery and initiation of IND‐enabling studies for a novel clinical development candidate, GBR 1372. GBR 1372 adds to Glenmark’s oncology portfolio of biologics including GBR 1302 (HER2xCD3 biospecific antibody) and GBR 1342 (CD38xCD3 bispecific antibody) based on its proprietary BEAT technology.

The epidermal growth factor receptor EGFR is a member of the ErbB family of receptor tyrosine kinases. EGFR is a well-established target for lung cancer and colorectal cancer. Current drugs prevent signaling through EGFR by blocking ligand binding or inhibiting its protein kinase activity but they cause considerable side effects and are not active against cancers with Ras mutations. Mutations in Ras genes continuously switch on intracellular signaling networks and make the tumours independent of stimulation by growth factor receptors such as EGFR and drugs that target EGFR are not currently indicated for patients with Ras mutations.

GBR 1372 kills cancer cells through redirecting T cells via its anti CD3-binding arm to EGFR expressing cancer cells through its EGFR-binding arm. Reportedly, Glenmark scientists in Switzerland have demonstrated preclinically that GBR 1372 is indeed equally active against EGFR expressing cancer cell lines – independent of their RAS mutation status.

Glenmark is likely to file an IND with the US FDA in the second half of the next financial year FY 2018.

Commenting on this development, Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals said, “We remain excited about the progress of our novel biologics pipeline. With the addition of GBR 1372, the quality of our biologics pipeline continues to improve. We continue to make strides as we transition to a global innovation led pharma organisation”.

Dr Fred Grossman, Chief Medical Officer, Glenmark Pharma mentioned, “We look forward to advancing GBR 1372 into clinical development in the near future”.

EP News Bureau – Mumbai