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, NJ, USA I December 7, 2017 I 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
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 targeting CD38 positive tumors including hematologic malignancies and solid tumors; and GBR 1372, an EGFRxCD3 bsAb targeting EGFR positive tumors including those resistant to standard of care.

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
Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with operations in more than 50 countries. Glenmark has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of immuno-oncology, respiratory disease and dermatology. Glenmark has improved the lives of millions of patients by offering safe, affordable medications for nearly 40 years. For more information, visit glenmarkpharma.com.

1 Immunol Rev. 2016 Mar; 270(1): 95–112.

SOURCE: Glenmark Pharmaceuticals

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