“In just the last year, three of the Company’s biologics, two of which are immuno-oncology agents, have begun clinical trials, which is a testament to the outstanding progress made by the global R&D workforce,” said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals.
GBR 1342 works by targeting CD38 and the CD3 T-cell co-receptor.
CD38 is an antigen target implicated in multiple myeloma and other malignancies of hematopoietic (blood stem cell) origin, as well as a variety of solid tumors.
“This first-in-human, open-label study’s primary objective is to assess the safety and tolerability of increasing doses of GBR 1342 in multiple myeloma patients until a maximum tolerated dose is reached,” Glenmark Pharma said.
The study will also test biomarkers, immunogenicity and additional measures of anti-tumor activity.
“Glenmark is committed to a new model of drug discovery that emphasizes quality and a highly efficient approach to clinical development, and this milestone for GBR 1342 is an example of this approach in action,” Grossman added.
Glenmark’s immuno-oncology pipeline currently includes three candidates being studied in a wide range of tumor types. These include three bispecific monoclonal antibodies (bsAbs).
GBR 1302, a HER2xCD3 bsAb, targets HER2+ expressing tumors including those not responsive to standard of care.
GBR 1342, a CD38XCD3 bsAb targets CD38 positive tumors including hematologic malignancies and solid tumors.
Finally, GBR 1372 targets EGFR positive tumors including those resistant to standard of care.
The company can efficiently manufacture these molecules at clinical and commercial scale, it said.