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.”

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

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CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

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Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Endpoints News writer Nicole DeFeudis has posted a snapshot of all the companies, universities and hospital-based groups now racing through the clinic, ranking them according to their place in the pipeline as well as the latest remarks available on timelines. And we’ll keep this lineup updated right through the end of the year, as the checkered flags start to fall, possibly as early as October.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

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How much has pre­ci­sion med­i­cine helped? A new NCI study of­fers clues

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The approach, based on finding a drug to target a patient’s specific genes, has undoubtedly saved individual lives, spurring Lazarus-like reversals in health in once-terminally ill patients. But critics have pointed out that its pursuit has meant drug companies spending hundreds of millions of dollars to target mutations that affect narrow slices of the populations, and that many of the gains researchers thought it would bring have eroded as cancers evolve resistance.

Credit: Galaxy Life Sciences

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Galaxy paid $1.9 million for a 6-acre plot, on which it intends to construct a $50 million building grossing 95,000 to 180,000 square feet. The space will be designed to accommodate research and development, or manufacturing, and could employ 125 to 150 workers, according to the Worcester Telegram & Gazette. Construction is expected to begin this spring and wrap up in about a year.

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CEO Tony (Bizuo) Liu is a key advocate of the deal, leading a consortium of mostly Chinese investors including other top company execs, Yunfeng Capital and TF Capital — even as the company is getting more entrenched in the US with its CAR-T and other cell therapy work.

Shareholders are receiving $19.75 per share $CBMG, which translates to a premium of 31.4% over the 30 trading-day average price as of August 11. The stock, though, has dropped significantly since the consortium first put in its proposal in November. Compared to then, the acquisition price marks only a 11.8% increase.