Ten years after acquiring deCODE Genetics, Amgen’s collaboration with the Icelandic genetic sleuths has only blossomed, expanding from drug discovery to clinical development.
The partners celebrated deCODE’s 25th anniversary Wednesday, a belated celebration due to the pandemic. The ceremony was an acknowledgment of deCODE’s achievements but also a recognition that its potential is far from tapped.
Founded in 1996, deCODE established itself as a global leader in utilizing genetics to estimate disease risk. At its core, deCODE is a data analysis company, combining genetic data with algorithms to comb through variants in genomes and compare them to changes in phenotype. The company has detailed genetic and medical information on roughly half a million people, including the majority of Iceland's adults.
What caught Amgen's eye was deCODE's potential to identify new disease targets quickly by zeroing in on these variants. As a result, Amgen shelled out $415 million to buy the company in 2012. By then, deCODE had already discovered genetic risk factors for dozens of diseases.
Now, Amgen envisions deCODE's largest impact happening in drug development, not just drug discovery. Amgen Senior Vice President of Global Research Ray Deshaies, Ph.D., said the two companies are now sharing data during clinical trials to refine and improve future phases. He said in one example, deCODE is using clinical data from one of Amgen’s phase 2 trials to identify clues that could better refine the patient population receiving treatment in a subsequent phase 3 trial.
A spokesperson later confirmed Deshaies was referring to olpasiran, a small interfering RNA treatment that’s designed to treat atherosclerotic cardiovascular disease by reducing lipoprotein (a).
The result is a relationship that’s grown into weekly conversations and consistent collaboration.
“We don’t communicate on a target for a year, this communication goes on for many years,” said Deshaies.
Another example of this alley-oop in action is Amgen’s FDA-approved, PCSK9 inhibitor Repatha to treat high cholesterol. Similar to olpasiran, deCODE founder Kári Stefánsson, M.D., said his company is drawing on data assessing protein levels in the blood to better predict who’s most at risk of cholesterol-related cardiovascular events. Those data will inform who should be recruited in a primary prevention study of the drug Amgen is just getting off the ground.
“If you include people like that in your trial, or if you use that to analyze the trial, you can squeeze out of it much, much more power than if you don’t,” he said.
Amgen’s R&D chief David Reese, M.D., referred to this kind of patient specification as the “endgame” of maximizing human data. He underscored both Stefánsson and Deshaies, saying that the company is now utilizing this type of precision medicine in its drug development program. But he also threw cold water on the idea that genetics is a magic bullet that could fix all clinical complications.
“Genetics is a starting point, but it is not necessarily an answer,” he said. “So, what you have to have is genetics … but then biology and the biology is complicated. I don't know that you can divorce one element from another.”