FDA clears Glenmark’s HER2+ cancer drug for Phase I trial
Posted: 3 January 2017 | | No comments yet
Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumour types, including breast, gastric and other cancers…
The US Food and Drug Administration (FDA) cleared Glenmark Pharmaceutical’s investigational new drug (IND) application to initiate a phase I study of its lead candidate, GBR 1302-BEAT, in patients with HER2+ cancers.
The company plans to expand the ongoing phase I clinical study to include sites in the United States for this potential treatment, a humanised, bispecific monoclonal antibody targeting HER2 and CD3, based on the BEAT (Bi-specific Engagement of Antibodies based on the T cell receptor) technology platform.
Preclinical studies suggest GBR 1302 may have activity against a range of HER2-expressing tumour types, including breast, gastric and other cancers.
“We believe GBR 1302 may have utility across a broad range of HER2+ tumour types. Data from preclinical studies are very encouraging,” said Fred Grossman, President and CMO at Glenmark.
“Based on its 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.”
Phase I trial
The phase I safety study is being conducted in two parts – dose escalation and expansion. The first part evaluates patients with previously treated HER2+ tumours to determine the safety and tolerability to maximum tolerated dose, as well as the pharmacokinetics and preliminary anti-tumour activity.
The second part of the study is an expansion study of the same population treated at the maximum tolerated dose to determine early proof-of-concept. Patients in Germany are currently being treated in the dose escalation part of the study.
BEAT (Bi-specific Engagement by Antibodies based on the T cell receptor) is Glenmark’s technology for production of bi-specific antibodies (bsAbs). Engaging two targets with one bispecific antibody is an approach to target cancer cells, in this case, by the redirection of cytolitic T cells. With the BEAT technology, Glenmark’s scientists have been able to overcome past production obstacles encountered with bsAbs and efficiently assemble and manufacture these molecules on an industrial scale.
GBR 1302 is the first compound based on this breakthrough antibody engineering technology in human trials.