Company Glenmark pharmaceuticals S. A., a fully owned unit of Glenmark pharmaceuticals limited India, announced the development and early research of innovative especificacao monoclonal antibody directed against the receptor of epidermal growth factor, GBR 1372, to compile a dossier of the investigational new drug. 1372 GBR is a Supplement to the portfolio of development of biological compounds Glenmark, which includes connection GBR 1302 (HER2xCD3 bespecifically antibody) and GBR 1342 (CD38xCD3 bespecifically antibody), developed on the basis of own technology BEAT®.
The receptor for epidermal growth factor (EGFR) belongs to the family of ErbB receptors, in particular to the subfamily tirozinkinazy receptors. EGFR is an established target in the treatment of lung cancer and colorectal cancer. Modern drugs inhibit the transmission of signals through EGFR by blocking bundles of ligands or inhibit the action of protein kinases, but they have a tangible adverse action and is not active against cancers with mutations of the RAS family. Mutations in RAS genes continuously activate intracellular network of signal transmission and make the tumor independent of stimulation by the growth factor receptor such as EGFR, while drugs that aim at EGFR are not intended for the treatment of patients with the presence of RAS mutations.
GBR 1372 destroys cancer cells by redirecting T-cells via the CD3 complex to cancer cells expressing EGFR through binding to the EGFR complex. Scientists Glenmark in Switzerland has demonstrated during preclinical studies is that GBR 1372 do runaction against EGFR overexpressing tumor cell lines regardless of their RAS mutation status.
Company Glenmark plans to file dossier of the investigational new drug in the Management of quality control food and drug administration (US FDA) during the second half of the next fiscal year (fiscal year 2018).
Chairman and managing Director of Glenmark pharmaceuticals Mr. Glenn Saldanha said: “We remain very positive about the development of our portfolio of innovative biological compounds. With the development of the GBR 1372 the quality of our portfolio of innovative biological compounds continues to improve. We continue to develop on the way to becoming Glenmark global company, the basis of which innovative developments”.
Head of medical services, Glenmark pharmaceuticals Etc. Fred Grossman: “We look forward to the time when GBR 1372 enter a phase of clinical development”.
BEAT® (interaction of bespecifically antibodies is based on the T-cell receptor) is a technology company Glenmark for the production of antibodies biospecifically. Connecting two targets with one bespecifically antibody is the newest concept for creation of new methods of treatment. Over the last 20 years bespecifically antibodies was a challenge to the medical industry, as the most developed bespecifically platforms had problems with stability and/or production. With the invention of the technology of BEAT®, Glenmark researchers overcome these obstacles, and can effectively develop and produce bespecifically antibodies.
Portfolio company developments: an innovative biological compounds
To date, the portfolio of the development company Glenmark has six innovative biological compounds that are at various stages of preclinical and clinical development. The mechanism of action of innovative connection GBR 900 is directed to the TrkA receptor for the treatment of chronic pain and is currently in phase I clinical trials. This project is developed under license from Lay Line Genomics, Italy. Monoclonal antibodies specific for TrkA represent the first in its class for the treatment of chronic pain, the treatment of which now falls in the unmet medical need. Connecting GBR 830 is a best-in-class antagonist of OX40 receptor to treat autoimmune diseases and is in phase II clinical development for the indication of “atopic dermatitis”. The process for the development of OX40 antagonists has been very challenging, but the company Glenmark has been able to achieve significant results through the successful creation of a monoclonal antibody antagonist of OX40, as well as data confirming the role of OX40 in the fight against autoimmune diseases.
GBR 1302 is the first clinical candidate developed on the basis of their own best-in-class platform of Glenmark – BEAT®. Also GBR 1302 is the first clinical candidate Glenmark referred for treatment of cancer. Technology platform BEAT® contributes to efficient development and production of dual specificity antibodies, bespecifically antibodies called. The antibody GBR 1302 has successfully passed preclinical phase. In preclinical studies GBR 1302 demonstrated superiority over existing drugs based on antibodies, which are directed to the treatment of most HER2-positive cancers, including breast cancer. GBR 1342— bespecifically antibody receptor CD38XCD3, is the second candidate for clinical development based on the technology BEAT®. GBR 1342 directed to CD38 in multiple myeloma and other potentially malignant tumors of hematopoietic origin. Company Glenmark has initiated research on a new drug for the compilation of dossiers on the GBR 1342 and is committed to the prompt conversion of this compound into phase I clinical studies.