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.”

Eli Lilly CEO David Ricks (Evan Vucci/AP Images)

A P val­ue of 0.38? NE­JM re­sults raise new ques­tions for Eli Lil­ly's vaunt­ed Covid an­ti­body

Generally, a P value of 0.38 means your drug failed and by a fair margin. Depending on the company, the compound and the trial, it might mean the end of the program. It could trigger layoffs.

For Eli Lilly, though, it was part of the key endpoint on a trial that landed them a $1.2 billion deal with the US government to supply up to nearly 1 million Covid-19 antibodies.

So what does one make of that? Was the endpoint not so important, as Lilly maintains? Or did the US government promise a princely sum for a pedestrian drug?

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Daphne Koller, Getty

Bris­tol My­er­s' Richard Har­g­reaves pays $70M to launch a neu­rode­gen­er­a­tion al­liance with a star play­er in the ma­chine learn­ing world

Bristol Myers Squibb is turning to one of the star upstarts in the machine learning world to go back to the drawing board and come up with the disease models needed to find drugs that can work against two of the toughest targets in the neuro world.

Daphne Koller’s well-funded insitro is getting $70 million in cash and near-term milestones to use their machine learning platform to create induced pluripotent stem cell-derived disease models for ALS and frontotemporal dementia.

Eli Lilly CEO David Ricks at the Rose Garden, May 26, 2020 (Evan Vucci/AP Images)

Eli Lil­ly lines up a block­buster deal for Covid-19 an­ti­body, right af­ter it failed a NI­AID tri­al

Two days after Eli Lilly conceded that its antibody bamlanivimab was a flop in hospitalized Covid-19 patients, the US government is preparing to make it a blockbuster.

The pharma giant reported early Wednesday that it struck a deal to supply the feds with 300,000 vials of the drug at a cost of $375 million — once it gets an EUA stamp from the FDA. And once that 2-month supply deal is done, the government has an option on another 650,000 doses on the same terms — which could potentially add another $812 million.

Noubar Afeyan, Flagship founder and CEO (Victor Boyko/Getty Images)

UP­DAT­ED: Flag­ship launch­es Sen­da Bio­sciences with $88M in back­ing, look­ing to pi­o­neer the field of 'In­ter­sys­tems Bi­ol­o­gy'

Flagship Pioneering has a fresh company out this week, one that aims to lay the groundwork for a whole new discipline.

Senda Biosciences launched Wednesday with $88 million in Flagship cash. The goal? Gain insights into the molecular connections between people and coevolved nonhuman species like plants and bacteria, paving the way for “Intersystems Biology.”

Guillaume Pfefer has been tapped to run the show, a 25-year biotech veteran who comes from GSK after leading the development of the company’s shingles vaccine.

Ar­cus and As­traZeneca part­ner on a high stakes an­ti-TIG­IT/PD-L1 PhI­II can­cer study, look­ing to im­prove on a stan­dard of care

For AstraZeneca, the PACIFIC trial in Stage III non-small cell lung cancer remains one of the big triumphs for AstraZeneca’s oncology R&D group. It not only made their PD-L1 Imfinzi a franchise player with a solid advance in a large niche of the lung cancer market, the study — which continues to offer data on the long-range efficacy of their drug — also helped salve the vicious sting of the failure of the CTLA-4 combo in the MYSTIC study.

No­var­tis buys a new gene ther­a­py for vi­sion loss, and this is one pre­clin­i­cal ven­ture that did­n't come cheap

Cyrus Mozayeni got excited when he began to explore the academic work of Ehud Isacoff and John G. Flannery at UC Berkeley.

Together, they were engaged in finding a gene therapy approach to pan-genotypic vision restoration in patients with photoreceptor-based blindness, potentially restoring the vision of a broad group of patients. And they did it by using a vector to deliver the genetic sequence for light sensing proteins.

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Sanofi teams up with Mer­ck to pair Keytru­da with a next-gen IL-2 can­di­date from the Syn­thorx buy­out

Nearly a year after snapping up a next-gen immuno-oncology candidate in its $2.5 billion Synthorx buyout, Sanofi is joining forces with Merck to pair the drug with blockbuster Keytruda.

The pharmas are planning a Phase II trial of Sanofi’s non-alpha IL-2 candidate THOR-707 in combination or sequenced administration with Keytruda for various cancers. While the companies are keeping mum about the financial terms and targets, they said the trials will be Sanofi-sponsored.

CMO Merdad Parsey (Gilead)

Gilead hits the brakes on a tri­fec­ta of mid- and late-stage stud­ies for their trou­bled fil­go­tinib pro­gram. It's up to the FDA now

Gilead $GILD execs haven’t decided exactly what to do with filgotinib in the wake of the slapdown at the FDA on their rheumatoid arthritis application, but they’re taking a time out for a slate of studies until they can gain some clarity from the agency. And without encouraging guidance, this drug could clearly be axed from the pipeline.

In their Q3 report out Wednesday afternoon, the company says researchers have “paused” a Phase III study for psoriatic arthritis along with a pair of Phase II trials for ankylosing spondylitis and uveitis. Late-stage studies for ulcerative colitis and Crohn’s are continuing, but you can see for yourself how big a hole this leaves in the inflammatory disease pipeline, with obvious implications if the company abandons filgo altogether.

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Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

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