Still pon­der­ing an M&A move, Gilead­'s R&D team out­lines a Q3 line­up of set­backs on 3 pipeline drugs

Gilead CEO John Mil­li­gan

Hit on one side by slump­ing hep C rev­enue and on the oth­er side by high ex­pec­ta­tions for its pipeline ef­fort, Gilead grim­ly hung on to sim­tuzum­ab af­ter the LOXL2 en­zyme block­er flopped in two straight stud­ies. Now the Big Biotech has added sev­er­al more fail­ures to the ros­ter and put the five-time los­er on the shelf for good.

And that’s not all.

Two more drugs al­so failed a line­up of clin­i­cal tri­al tests, leav­ing Gilead $GILD look­ing weak­er on the R&D front at pre­cise­ly the time it needs to show strength. In ad­di­tion to sim­tuzum­ab, the biotech al­so wrote off the late-stage drug GS-5745 for ul­cer­a­tive col­i­tis and Crohn’s. And it’s top car­dio prospect failed a study as well, sig­nif­i­cant­ly re­duc­ing its chances of be­com­ing the big new drug that Gilead needs as hep C wanes. Mean­while, its Q3 R&D ex­pens­es spiked, large­ly due to the $200 mil­lion pay­ment it just made to Nim­bus.

Add it up and Gilead now more than ever needs to do some­thing big for the pipeline, but CEO John Mil­li­gan con­tin­ued to in­sist that the com­pa­ny will bide its time in find­ing the right deals. He not­ed:

(O)ur in­ter­est in part­ner­ships and po­ten­tial ac­qui­si­tions is not lim­it­ed to on­col­o­gy, and we are con­sid­er­ing op­por­tu­ni­ties where there is strong sci­ence and where we see the pos­si­bil­i­ty of de­vel­op­ing a tru­ly dif­fer­en­ti­at­ed prod­uct. We’ve been go­ing through an ex­ten­sive in­ter­nal re­view of pro­grams and op­por­tu­ni­ties, and an im­por­tant as­pect of our ap­proach is that we re­main open-mind­ed, but dis­ci­plined. So while we have the bal­ance sheet to ex­e­cute on mul­ti­ple op­por­tu­ni­ties, we will keep the bar high.

Gilead CSO Nor­bert Bischof­berg­er

Gilead R&D chief Nor­bert Bischof­berg­er was left to sound taps on the drug tri­als dur­ing the Q3 re­view Tues­day evening, start­ing with sim­tuzum­ab, which has now failed 5 stud­ies, in­clud­ing three re­cent 96-week at­tempts:

The da­ta in­di­cate that, while safe and well-tol­er­at­ed, there is no ev­i­dence of ef­fi­ca­cy in one study in pri­ma­ry scle­ros­ing cholan­gi­tis and in two stud­ies in NASH. One NASH study was in pa­tients with cir­rho­sis and one was in pa­tients with liv­er (20:54) fi­bro­sis. Con­se­quent­ly, we will not de­vel­op sim­tuzum­ab any fur­ther in these or any oth­er in­di­ca­tions. We will present these da­ta at fu­ture con­fer­ences.

The drug al­ready failed for pan­cre­at­ic can­cer and id­io­path­ic pul­monary fi­bro­sis.

As for GS-5745, an an­ti-MMP-9 an­ti­body, we stopped a Phase II/III study in pa­tients with ul­cer­a­tive col­i­tis be­cause of the lack of ef­fi­ca­cy. This de­ci­sion for the planned in­ter­im DSMB analy­sis af­ter the first 150 pa­tients had been en­rolled, that the study met pre-de­fined fu­til­i­ty cri­te­ria. Al­so, and not un­ex­pect­ed­ly, there was no ev­i­dence of ben­e­fit of GS-5745 in a Phase II study in pa­tients with Crohn’s dis­ease. Con­se­quent­ly, we will not fur­ther pur­sue GS-5745 for ul­cer­a­tive col­i­tis or Crohn’s.

And then came the car­dio drug ele­clazine.

Ele­clazine, or GS-6615, failed to meet its pri­ma­ry end­point in a study of pa­tients with ven­tric­u­lar tachy­car­dia, ven­tric­u­lar fib­ril­la­tion, or VT/VF, and im­plant­ed car­diovert­er-de­fib­ril­la­tors. Pa­tients were ran­dom­ized to two dos­es of ele­clazine or place­bo. The pri­ma­ry end­point was the num­ber of elec­tri­cal in­ter­ven­tions, in­clud­ing shocks and pac­ing, by the im­plant­ed de­vice. And there was no ev­i­dence of ef­fi­ca­cy of ele­clazine com­pared to place­bo. Con­se­quent­ly, we will not de­vel­op ele­clazine any fur­ther for VT/VF. Eval­u­a­tion in long QT-3 syn­drome and in hy­per­trophic car­diomy­opa­thy is con­tin­u­ing.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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Grail’s blood test charts path for di­ag­nos­ing pa­tients sus­pect­ed of hav­ing can­cer in large study: #AS­CO23

Grail’s vision is simple but bold. The blood testing company has long held that people are often diagnosed with cancer too late. If seemingly healthy people were screened for early signs of the disease before symptoms appear, they may be able to get more effective treatments that nip cancer in the bud.

That premise is the basis of Grail’s commercial blood test, Galleri, which searches for the genetic fingerprints of cancer in the blood. The test, launched in 2021, reaped $55 million in sales last year, but now the company is setting its sights on a new market: patients suspected of having cancer due to symptoms such as abdominal pain, rectal bleeding or unexplained weight loss. Rather than administering expensive scans or conducting invasive biopsies right away, Grail hopes doctors will consider a simple blood test.

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Novartis headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

No­var­tis’ Kisqali pre­vents breast can­cer from com­ing back for longer — but can it best Eli Lil­ly’s Verzenio? #AS­CO23

CHICAGO — Novartis’ CDK4/6 inhibitor Kisqali helped early breast cancer patients stay cancer-free for longer after surgery, according to interim study results presented at ASCO.

In a Phase III study, Kisqali was added on top of endocrine therapy — the current standard treatment for early breast cancer patients. Kisqali reduced the risk of disease relapse by 25% compared with endocrine therapy alone in patients with Stage II or III HR-positive, HER2-negative breast cancer.

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GSK pro­motes rou­tine im­mu­niza­tions for adults amid post-pan­dem­ic vac­cine back­slide

GSK launched a new initiative on Thursday and committed up to $1 million in grant funding to improve adult routine vaccination rates.

While the pandemic spotlight was trained on the race for novel Covid-19 vaccines, other routine vaccination rates plummeted, raising concerns that missed doses may put children and even some adults at risk of preventable diseases such as measles or shingles. The World Health Organization last year reported the largest drop in childhood vaccinations in roughly three decades.

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Tammie Denyse speaks up about Black women and breast cancer inequity in Gilead's first TikTok campaign. (Gilead Sciences)

Gilead joins Tik­Tok with on­col­o­gy aware­ness cam­paign fea­tur­ing di­verse group of can­cer ad­vo­cates

Gilead Sciences is taking over the opening page on TikTok for the next two weeks. A Gilead-sponsored video, featuring cancer advocates talking about equity and other issues, will show up as the landing page, called the “For You” page, for millions of TikTok watchers.

The cancer awareness campaign will begin on Monday and run for two weeks, a Gilead spokesperson told Endpoints News. The TikTok ad debut is timed around the ASCO medical conference, but the work is aimed more broadly at healthcare professionals, as well as people touched by cancer and people interested in advancing Black and general health equity.

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Stephen MacMillan, Hologic CEO (Photo by Riccardo Savi/Getty Images for Concordia Summit)

Il­lu­mi­na names Ho­log­ic CEO as new board mem­ber and chair

Illumina’s board appointed two new members, including Hologic CEO Stephen MacMillan as the non-executive chair, a move that followed a proxy fight that saw shareholders oust the company’s board chair.

The DNA sequencing company also appointed Scott Ullem, the CFO of Edwards Lifesciences, to the board, according to a company statement.

Illumina’s plans to add two new board members came as Carl Icahn waged a board proxy campaign culminating with shareholders electing his candidate, Andrew Teno, over board chair John Thompson. Illumina CEO Francis deSouza survived a threat to his board seat by securing more than twice the shareholder votes than his challenger. Another Illumina candidate, Robert Epstein, was also elected and remained on the board.

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Catal­ent makes ad­di­tion­al lay­offs at In­di­ana fa­cil­i­ty

Contract manufacturer Catalent is making more staff cuts at one of its locations in the US amid dramatic corrective actions it’s been taking over the past few months.

In an email to Endpoints News, a Catalent spokesperson confirmed the company is making “a number of personnel changes” at a manufacturing facility in Bloomington, IN. While a specific number was not given to Endpoints, several local media outlets, including Indiana Public Media and the Bloomington Herald-Times, have put the number of layoffs at 150. No postings have been made to the Indiana Department of Workforce Development’s WARN notice.

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