India's Glenmark says breast cancer candidate GBR 1302 moving to PhI

The European unit of India's Glenmark Pharmaceuticals has applied to move into Phase I clinical trials for GBR 1302, a HER2xCD3 bispecific antibody that the company said in preclinical work demonstrated superiority over current antibody therapies against most HER2-positive cancers, including breast cancer.

The application to the Paul Ehrlich Institute in Germany would mark the company's first clinical development candidate based on a technology protocol for production of bispecific antibodies dubbed BEAT, with the trial seen started by the end of March 31, 2016, the company said in a press release.

"GBR 1302 material for Phase I clinical trials was manufactured in Glenmark GMP production unit in Switzerland," the company said in the release. "HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the multibillion dollar antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is implicated in breast cancer, ovarian, gastric, and certain uterine cancers."

The company said that clinical success would "constitute an innovative treatment for HER2 positive cancers that is potentially superior to the current established monoclonal antibody treatments, Herceptin (trastuzumab), Perjeta (pertuzumab) and Kadcyla (trastuzumab emtansine)."

In May, Glenmark said it was forging ahead with its plans to generate international growth after earlier in the year saying it was looking for global partners to market 7 molecules for various treatments in development. The statement followed an investment by Temasek Holdings, Singapore's state-owned investment firm, in April.

Glenmark Managing Director Glenn Saldanha

The company said it has spent more than $200 million in R&D expenses over 9 years, while the 7 molecules are already outlicensed and have generated $217 million in upfront and milestone payments so far, according to Glenn Saldanha, Glenmark's chairman and managing director.

Glenmark is also in a closely watched court battle with Merck ($MRK) over whether it can sell copies of Januvia and Janumet, Merck's innovative version of the Type 2 diabetes drug.

Glenmark said it now has four monoclonal antibodies in its pipeline with three in active clinical development.

- here's the release