CHICAGO--The top contenders wrestling for the spotlight reserved for breakout cancer drugs at the ASCO Annual Meeting 2016 this year share a common distinguishing factor: They are designed to take a novel shot at a new target. And Ganymed Pharmaceuticals, a little-known German biotech backed by billionaire twins, rode that targeting trend straight to the center ring on Sunday.
Investigators on the drug say that Ganymed’s IMAB362 “can significantly extend median survival when added to standard chemotherapy--13.2 months vs. 8.4 months--for patients with advanced gastric cancer.” This therapy is the first drug that targets a protein called claudin18.2, and patients in the study with the highest levels of claudin18.2 had a significantly longer median overall survival rate: 16.7 months.
This study included 161 patients, setting the stage for a Phase III launch next year and a possible followup with regulators.
Claudin18.2 is a member of a family of proteins that plays a crucial role in creating “tight junctions” in cells, governing paracellular barriers. In tumors, though, these tight junctions become disrupted, scrambling their cellular role. And the same target can be found in other tumors, including pancreatic, lung, esophageal and ovarian.
Compared with chemotherapy alone, note researchers, the drug arm extended the median time to disease progression from 4.8 to 7.9 months; the median overall survival rate was stretched from 8.4 to 13.2 months. Among the patients with the highest levels of claudin18.2, the median overall survival was 16.7 months with IMAB362 and 9 months with chemotherapy alone.
The biotech has been focusing on the drugs emerging from the research done by Dr. Özlem Türeci and Professor Ugur Sahin. And it’s been notably well funded, with some standout backers in Europe.
The identical twins Thomas and Andreas Strüngmann, who founded the big generics company Hexal and sold it to Novartis ($NVS) for $7.5 billion, helped Ganymed raise $60 million (€45 million) in a venture round back in 2013, bringing the total at the time to $148 million. MIG Fond and FCPB Gany GmbH also put up part of the venture funds.
“As claudin18.2 is abundant in gastric tumors, we estimate that half of all patients with advanced gastric cancer may be candidates for this new treatment,” said lead study author Dr. Salah-Eddin Al-Batran, a medical oncologist and director at the Institute of Clinical Cancer Research, Nordwest Hospital in Frankfurt am Main, Germany. “In addition, this unique target is not present in any healthy tissues except the lining of the stomach, thereby minimizing treatment side effects.”
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