Glenmark receives IND application clearance to begin Phase I trial of GBR 1302-BEAT for HER2+ cancer

The US Food and Drug Administration (FDA) has cleared pharmaceutical company Glenmark’s investigational new drug (IND) application to begin a phase I trial of GBR 1302-BEAT to treat HER2+ cancers.

Bi-specific engagement by antibodies based on the T-cell receptor (BEAT) has been designed to produce bi-specific antibodies (bsAbs) that engage with two targets to affect cancer cells, which in the case of HER2+ cancers redirects cytolitic T-cells.

Glenmark president and chief medical officer Fred Grossman said: “We believe GBR 1302 may have utility across a broad range of HER2+ tumour types.

“Data from preclinical studies are very encouraging.

“Based on its novel mechanism of redirecting T-cells to HER2+ cancer cells, GBR 1302 has the potential to become an important therapy for previously treated and, eventually, newly diagnosed HER2+ tumours.”

The phase I trial will be carried out in two parts, the dose escalation and expansion.

The dose-escalation will examine patients with previously treated HER2+ tumours in order to test safety and tolerability, as well as the pharmacokinetics and preliminary anti-tumour activity of the maximum dose of GBR 1302-BEAT .

The expansion will examine the same population treated with the maximum tolerated dose to determine early proof-of-concept.

Preclinical studies suggested that GBR 1302 is supposedly active against a range of HER2-expressing tumour types, including breast, gastric and other cancers.