Glenmark Pharmaceuticals Announces Dosing of First Patient With Investigational Immuno-Oncology Agent GBR 1342
GBR 1342, a CD38XCD3 bispecific monoclonal antibody based on the proprietary BEAT® bispecific antibody engineering platform, is Glenmark's second immuno-oncology agent to enter clinical trials
MAHWAH, N.J., Dec. 7, 2017 /PRNewswire/ -- Glenmark Pharmaceuticals, a global pharmaceutical company, today announced that the first patient has been dosed in a Phase 1 trial of GBR 1342 (NCT03309111), an investigational bispecific antibody. 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. Additional study objectives include assessment of 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," said Fred Grossman, President and Chief Medical Officer at Glenmark Pharmaceuticals. "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."
GBR 1342 simultaneously targets CD38, as well as the CD3 T cell co-receptor. CD38 is an antigen target implicated in multiple myeloma and other malignancies of hematopoietic origin, as well as a variety of solid tumors.1
About Glenmark's Immuno-Oncology Pipeline and Proprietary BEAT® Technology
BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) is Glenmark's proprietary technology for the production of bsAbs. With BEAT® technology, Glenmark's scientists have been able to overcome past production obstacles encountered with bsAbs, and can efficiently manufacture these molecules at clinical and commercial scale. Preclinically, BEAT® bsAbs demonstrate the potential for more potent activity compared to existing therapeutic antibodies. Additionally, structural similarity to naturally-occurring antibodies may result in a normalized IgG half-life and less immunogenicity. GBR 1302, GBR 1342 and GBR 1372 are based on BEAT® technology.
About Glenmark Pharmaceuticals
1 Immunol Rev. 2016 Mar; 270(1): 95-112.
SOURCE Glenmark Pharmaceuticals