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Genentech shelves Phase 2 cancer contender

April 29, 2017

In July 2014, Genentech (RHHBY), part of Roche (RHHBY), acquired Seragon Pharmaceuticals, a privately held biotech company in San Diego. It picked up the rights to Seragon’s complete portfolio of next-generation oral selective estrogen receptor degraders (SERDs) for hormone receptor-positive breast cancer, including GDC-0810.

Genentech has now apparently abandoned the drug from Phase II trials with little fanfare or explanation.

In the terms of the original deal, Genentech paid $725 million upfront, plus potential milestone payments up to $1 billion. At that time Genentech stated, “Seragon’s lead product candidate, ARN-810, is a next-generation SERD that is currently in Phase I clinical trials for patients who have hormone receptor-positive breast cancer and have failed current hormonal agents. These next-generation SERDs complement Genentech’s existing research and development programs in breast cancer.”

John Carroll, writing for Endpoints News, notes that at the time, Helen Thomas, who was then writing a Heard on the Street column for the Wall Street Journal, had described the deal as “disconcerting,” saying, “Rarely in other sectors do companies shell out vast sums for assets that could quite possibly amount to nothing.”

Whether that’s true or not, it generally doesn’t apply to Genentech, which is notoriously disciplined about its investments.

Seragon itself had a mixed history. Carroll writes, “Seragon was what was left after J&J came in and bought Aragon—[Rich] 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.’”

Carroll indicates he has contacted Genentech to ask about why they dropped the compound. ClinicalTrials.gov indicates that the two trials of the drug have been completed. The first trial was “A Pharmacokinetic Study of [14C]-GDC-0810 After Single Oral Administration in Healthy Female Participants” and the second was “Effect of GDC-0810 on the Pharmacokinetics of Pravastatin in Healthy Female Subjects of Non-Childbearing Potential.”

Otherwise, Genentech announced yesterday that it had new data from its Ocrevus (ocrelizumab) Phase II and Phase III trials for relapsing or primary progressive forms of multiple sclerosis (MS). In the first eight weeks of the study, Ocrevus cut the relapse rate by 55 percent compared with Rebif (interferon beta-1a). In a separate Phase II study in relapsing-remitting MS (RRMS), Ocrevus showed rapid and near-complete suppression of brain MRI activity at eight weeks.

“The rapid effect seen with Ocrevus in clinical trials provides insight into how this newly FDA-approved therapy could change the way MS is treated,” said Stephen Hauser, chair of the Scientific Steering Committee of the OPERA studies, in a statement. Hauser is also director of the Weill Institute for Neurosciences and chair of the Department of Neurology at the University of California, San Francisco. “Following the FDA approval of Ocrevus for relapsing or primary progressive forms of MS, it is encouraging to see the medicine’s favorable benefit-risk profile continue to play out in the data.”

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