Re­gen­eron, Sanofi talk up po­ten­tial block­buster fran­chise as Dupix­ent sweeps in rhi­nos­i­nusi­tis PhI­II

A busy clin­i­cal team at Re­gen­eron $REGN and Sanofi $SNY has out­lined an­oth­er seg­ment on the al­ler­gic in­flam­ma­to­ry map that they plan to build their Dupix­ent king­dom up­on.

In two Phase III tri­als, in­ves­ti­ga­tors say, the mega-block­buster hope­ful de­liv­ered a clean sweep over chron­ic rhi­nos­i­nusi­tis with nasal polyps, clear­ing ob­struc­tion and shrink­ing ab­nor­mal tis­sue growth at a much high­er rate than place­bo.

Bri­an Sko­r­ney

The “in­cre­men­tal­ly pos­i­tive” re­sults, as Baird an­a­lyst Bri­an Sko­r­ney puts it, come days ahead of an ex­pect­ed reg­u­la­to­ry de­ci­sion on the mod­er­ate-to-se­vere asth­ma ap­pli­ca­tion, which Sanofi and Re­gen­eron sent in af­ter Dupix­ent hit key end­points in a Phase III a year ago.

While an­a­lysts were more skep­ti­cal of the drug’s com­mer­cial po­ten­tial in asth­ma due to com­pe­ti­tion from both ex­ist­ing (GSK’s Nu­cala) and up­com­ing ri­vals (teze­pelum­ab from As­traZeneca and Am­gen), in this case Sko­r­ney is more in­ter­est­ed in the fact that Dupix­ent beat the cur­rent stan­dard of care — oft-in­ef­fec­tive cor­ti­cos­teroid fol­lowed by ex­pen­sive surgery.

Dupix­ent’s demon­strat­ed abil­i­ty to sig­nif­i­cant­ly re­duce symp­toms in a heav­i­ly pre-treat­ed pa­tient pop­u­la­tion in which more than half of the pa­tients had pre­vi­ous­ly un­der­gone surgery, and near­ly 75% had used cor­ti­cos­teroids, should dri­ve strong com­mer­cial up­take in this in­di­ca­tion where there re­mains a sig­nif­i­cant un­met need.

George Yan­copou­los

SI­NUS-24 and SI­NUS-52 en­rolled 276 and 448 pa­tients, re­spec­tive­ly. At 24 weeks, pa­tients in the two tri­als who re­ceived a com­bo of Dupix­ent and cor­ti­cos­teroid nasal spray ex­pe­ri­enced a 51% and 57% im­prove­ment in nasal con­ges­tion/ob­struc­tion sever­i­ty, ver­sus 15% and 19% in the two place­bo (plus nasal spray) arms. In the drug arms, pa­tients’ nasal polyps score — which mea­sures the size of their polyps — shrunk by an av­er­age of 27% and 33%, while those on place­bo saw 4% to 7% in­creas­es.

Those are the co-pri­ma­ry end­points, with p < 0.0001; the part­ners say Dupix­ent al­so scored on key sec­ondary end­points, from “demon­strat­ing a sig­nif­i­cant re­duc­tion in the need for sys­temic cor­ti­cos­teroids or surgery” to “im­prove­ments in smell and chron­ic rhi­nos­i­nusi­tis symp­toms.”

John Reed

Track­ing a pre-spec­i­fied group of pa­tients who al­so has asth­ma — a com­mon predica­ment among chron­ic rhi­nos­i­nusi­tis suf­fer­ers — re­searchers al­so note an im­prove­ment in lung func­tion and asth­ma con­trol.

“With these da­ta, Dupix­ent has now been shown to ad­dress this in­flam­ma­tion across the com­plete air­way, which man­i­fests in the up­per res­pi­ra­to­ry tract as polyps and con­ges­tion, and in the low­er air­way as asth­ma,” said Re­gen­eron pres­i­dent and CSO George Yan­copou­los, who led the de­vel­op­ment team cred­it­ed for the IL-4/IL13 an­ti­body.

Add that to eczema, where the drug land­ed its first big OK, and it makes three Type 2 or al­ler­gic in­flam­ma­to­ry dis­eases where Dupix­ent has “demon­strat­ed sig­nif­i­cant late-stage ef­fi­ca­cy,” he said in a state­ment.

Ge­of­frey Porges, Leerink

That con­text is key for Ge­of­frey Porges of Leerink, who main­tains that de­spite the strength of the da­ta and the clear po­ten­tial ben­e­fit, “the great­est boost from nasal poly­po­sis will be from in­cre­men­tal share gains in oth­er co-mor­bid atopic/al­ler­gic con­di­tions.” He ex­plains:

Bar­ri­ers to adop­tion in this in­di­ca­tion will be the high cost and con­tin­u­ing bur­den of treat­ment ( ~$36,000/year and bi­week­ly in­jec­tions) and the dif­fer­ent physi­cian pop­u­la­tion (ENT sur­geons) treat­ing polyps, who may not be in­cen­tivized to treat with a bi­o­log­ic agent ver­sus pro­ce­dure. To the ex­tent some of these pa­tients are iden­ti­fied and in the care of al­ler­gists al­ready, they may be more ac­ces­si­ble for Dupix­ent, but sur­geons are like­ly to be slow­er con­vert­ers to in­jectable treat­ment.

“(W)e look for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties around the world to make Dupix­ent an op­tion for peo­ple liv­ing with this chron­ic con­di­tion,” added John Reed, glob­al head of R&D at Sanofi.

Porges es­ti­mates reg­u­la­to­ry fil­ings in 2019 and FDA ap­proval, if it is to come, in 2020.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Iterum's fu­ture looks un­cer­tain, af­ter lead an­tibi­ot­ic fails con­sec­u­tive piv­otal stud­ies

While the market for antibiotics remains in tatters — unlike many of its bankrupt (or at the brink of bankruptcy) peers — Iterum is suffering not because its antibiotic isn’t selling, but because the compound has now failed back-to-back late-stage studies.

The experimental drug, sulopenem, was designed to tackle drug-resistant infections with an outpatient focus (in addition to hospitals), to avert those reimbursement challenges that incentivize hospitals to prescribe cheaper, generic broad-spectrum antibiotics.

Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Covid-19 roundup: Did in­sid­ers cash in on pos­i­tive news re­port about Gilead be­fore pub­li­ca­tion?

A series of bullish trades on Gilead options just before the release of a favorable news story is raising questions among regulatory experts, Reuters reported.

On April 16, just hours before STAT published anecdotes from a Chicago hospital that served as one of the clinical sites to test Gilead’s remdesivir in Covid-19 patients, the California-based company’s shares were trading at around $75. Four large blocks of options were purchased for about $1.5 million each, betting that the stock would rise beyond that to as much as $87.5 by mid-August.

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Roche nabs front­line OK for Avastin/Tecen­triq in com­mon liv­er can­cer, best­ing an old Bay­er drug

For the first time in 12 years, the FDA has approved a new frontline treatment for the most common form of liver cancer.

The agency okayed a combination of Roche’s anti-VEGF antibody Avastin and their immunotherapy Tecentriq for patients with unresectable or metastatic hepatocellular carcinoma (HCC). The approval comes two weeks after Roche and their big biotech sub Genentech published Phase III results showing the combo improved both progression-free survival and, crucially, helped patients live longer than the long-running standard-of-care, Bayer’s Nexavar.