Drug Development

Roche silently whisks away its lead $1.7B Seragon drug in a Q1 footnote

Rich Heyman

Close to three years ago Roche’s Genentech team came in and bought out Seragon from Rich Heyman for $725 million in cash and another billion dollars in milestones, heralding the potential for selective estrogen receptor degraders to “one day redefine the standard of care for hormone receptor-positive breast cancer.”

Today, the pharma giant quietly carried the lead drug from that deal out to the curb, noting in a footnote on program terminations that it was removing the drug GDC-0810 (ARN-810, RG6046) from Phase II.

In response to a query, Roche says that 0810 is being shelved now so the company can move forward with another one of Seragon’s drugs in the same field that has better potential — and they’re just as interested in SERDs as ever. Their statement:

Genentech has decided to halt further clinical development and ongoing studies evaluating GDC-0810 while we evaluate our strategic options for our Selective Estrogen Receptor Degraders (SERDs) program.
We have learned much about the SERD biology with targeting the estrogen receptor. Based on current data, GDC-0927, another next-generation oral SERD, appears to have greater potential than GDC-0810 to be a best-in-class SERD molecule. We have decided to move forward with GDC-0927 in patients with metastatic hormone receptor-positive/HER2-negative breast cancer building upon what we have learned in the clinic with GDC-0810. In Q1 2015, we initiated a Phase I dose-escalation trial to assess the safety, tolerability, and pharmacokinetics of GDC-0927 in patients with metastatic hormone receptor-positive/HER-negative breast cancer who have progressed after receiving current anti-hormonal medicines.
Genentech remains committed to continuing to invest in SERD biology and novel SERD therapies. We believe investigational next-generation oral SERDs could one day redefine the standard of care for hormone receptor-positive breast cancer.

The reversal marks an unusual setback for Genentech and Roche, which rarely spend that kind of money on an experimental asset. Helen Thomas, who was then writing Heard on the Street for the Wall Street Journal, found it “disconcerting” at the time.

“Rarely in other sectors,” she noted, “do companies shell out vast sums for assets that could quite possibly amount to nothing.”

Seragon was what was left after J&J came in and bought Aragon — Heyman’s San Diego biotech created to pursue the insights of noted investigator Charles Sawyers — in one of its billion-dollar buyouts ($650 million in cash). Standard therapies for breast and prostate cancer are designed to block the effect of the hormones, acting like “glue in the lock” of hormone receptors, then-Aragon CEO Heyman told me back in 2010. But over time, patients become treatment resistant and the therapy can wind up fueling the cancer. Heyman called his lead therapy for prostate cancer “super glue. It truly blocks the receptor in this resistant state.”


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RAPS Regulatory Convergence 2017