Glenmark to start phase 1 trial of oncology drug GBR 1302 in Europe

Glenmark to start phase 1 trial of oncology drug GBR 1302 in Europe

Research-driven pharma company Glenmak said it would soon start the phase 1 trial of its oncology drug GBR 1302 in Europe.

It recently held a meeting with the German authorities and decided the phase 1 trial will be conducted directly on patients. The company has also given a guidance for its India business topline growth at 17-20% this year.

In a recently held second quarter earnings call, Glenn Saldanha, chairman and managing director, Glenmark, said, "Our India business continues to do exceedingly well for us. And we think on a full-year basis, we'll finish anywhere from 17% to 20% in terms of our top line growth. I think even going into next year you should see strong growth coming out of the India business."

The company also said that it will start clinical trial for its innovative monoclonal antibody GBR 1302 by the end of this year. It is a genetically engineered molecule and will be used for study of breast cancer.

"We have a meeting with the German regulatory authorities. If we get a positive decision we should start filing for clinical trials and start towards the end of this year. The good news is that the Phase 1 trial will be directly on patients, because this is an oncology products for breast cancer," Saldanha said.

GBR 1302 is the first clinical candidate targeting oncology indications. The BEAT (bispecific engagement by antibodies based on the T cell receptor) antibody technology platform facilitates the efficient development and manufacture of antibodies with dual specificities called bispecific antibodies. This is the fourth monoclonal antibodies in the Novel Biologics Entity (NBE) pipeline with remaining three of them already undergoing active clinical development.

"One (Vatelizumab GBR 500 –indicated for treatment of multiple sclerosis and other autoimmune diseases) we've licesened with Sanofi, two more (GBR 900 – targets TrkA receptor for chronic pain and is developed under license from Italy-based Lay Line Genomics S.p.A, and GBR 800 – OX40 antagonist for autoimmune diseases) in Phase 1 and GBR 1302 entering Phase 1. So I think we are very uniquely positioned on the novel biologic side. Our direction and goal is to continue to look at licensing some of these assets at different stages of development," Saldanha added.

On its plan to license GBR 1302, he said, "As far as licensing discussions go, clearly there's a lot of interest. There's a lot of interest around this whole technology and around the asset in particular. So from a licensing perspective, we will open up licensing pretty quickly. In all likelihood our thinking right now is to do deals on a product-by-product basis basically."

Glenmark has filed one Abbreviated New Drug Application (ANDA) with the US FDA during the quarter, and plans to file four additional applications in the forthcoming quarters. During the first six months of the financial year, Glenmark has filed 11 ANDAs.