Ab­b­Vie boasts a PhI­II sweep for top pso­ri­a­sis con­tender risankizum­ab, but it has lots of com­pe­ti­tion

Ab­b­Vie paid Boehringer $595 mil­lion up­front to li­cense rights to risankizum­ab in ear­ly 2016, and this morn­ing the com­pa­ny dis­played a late-stage dataset on pso­ri­a­sis ex­plain­ing why they want­ed this drug so bad­ly, stay­ing on track to cre­at­ing a new fran­chise play­er the phar­ma com­pa­ny be­lieves can reg­is­ter $4 bil­lion to $5 bil­lion in peak an­nu­al sales.

In a Phase III dou­ble head­er, re­searchers pit­ted the drug against two key — though fad­ing — last-gen­er­a­tion main­stays in the field, Ste­lara (ustek­inum­ab) and its own mega-drug Hu­mi­ra (adal­i­mum­ab). Their top prospect came through on all scores, out­pac­ing the oth­er two in clear­ing pso­ri­a­sis while the place­bo arm com­par­i­son num­bers bare­ly budged.

PASI 90 — a 90% clear­ance rate — came in at 75% twice and 72% for their 150 mg dose, com­pared to a set of ri­val drug re­spons­es rang­ing in the 40s. At one year, 56% and 60% of risankizum­ab pa­tients achieved com­plete skin clear­ance (PASI 100) com­pared to Ste­lara.

Kris­t­ian Re­ich

Ab­b­Vie re­port­ed:

Across all three tri­als, all pri­ma­ry and ranked sec­ondary end­points achieved p-val­ues of <0.001.

“In this tri­al, 4 out of 5 pa­tients achieved clear or al­most clear skin with risankizum­ab at week 16. High lev­els of skin clear­ance, PASI 90, were al­so seen at week 44 for pa­tients who re­ceived risankizum­ab, with a 12-week dos­ing reg­i­men,” said prin­ci­pal in­ves­ti­ga­tor Kris­t­ian Re­ich.

Of course, Ab­b­Vie, like the oth­er de­vel­op­ers out to make a mark in this block­buster field, are go­ing against some soft tar­gets. No­var­tis just rolled out im­pres­sive 5-year fol­lowup da­ta on Cosen­tyx, the first of the new-wave drugs to hit the mar­ket. Since No­var­tis el­bowed in­to the mar­ket, Eli Lil­ly has be­gun field­ing Taltz, Valeant is push­ing the trou­bled Siliq and J&J bagged a key FDA win in Ju­ly for its own block­buster IL-23 con­tender guselkum­ab.

Guselkum­ab slapped aside Hu­mi­ra, with J&J’s drug achiev­ing an IGA 0/1 score of 84% ver­sus 67.7% and a PASI 90 of 70% com­pared to 46.8%, re­spec­tive­ly.

In one as­sess­ment of sales po­ten­tial, Guselkum­ab reg­is­tered a peak sales fore­cast of $1.6 bil­lion, which al­so helps il­lus­trate the op­por­tu­ni­ties here.

Ab­b­Vie’s drug blocks IL-23 by bind­ing to its p19 sub­unit, and like the oth­er big play­ers in this field, the drug is in Phase III for Crohn’s dis­ease and pso­ri­at­ic arthri­tis, with an­oth­er pro­gram be­ing prepped for ul­cer­a­tive col­i­tis.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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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

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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