Ab­b­Vie re­treats as Gala­pa­gos of­fers mixed PhII CF da­ta, leav­ing a ma­jor al­liance in per­il — Ver­tex shares surge

Gala­pa­gos $GLPG out­lined some dis­tinct­ly mixed re­sults from its Phase II study of its C2 cor­rec­tor GLPG2737 for cys­tic fi­bro­sis Thurs­day af­ter­noon, man­ag­ing to boost the prospects of ri­val Ver­tex in the process.

While Gala­pa­gos said that the drug — com­bined with a sta­ble dose of Ver­tex’s Orkam­bi — had hit a sig­nif­i­cant de­crease of 19.6 mmol/L (p=0.02) on sweat chlo­ride from base­line, there was on­ly a pos­i­tive trend in ppFEV1. “The mean ab­solute change from base­line in ppFEV1 for the GLPG2737 treat­ment arm ver­sus place­bo through day 28 was 3.4% (p=0.08).”

That’s not good. Just lis­ten to Baird’s Bri­an Sko­r­ney:

The lack­lus­ter FEV1 per­for­mance re­al­ly makes it tough to imag­ine Gala­pa­gos mount­ing a rel­e­vant com­pet­i­tive cam­paign against Ver­tex’s triple com­bi­na­tion. Re­call, each of Ver­tex’s third agents showed about a 10% im­prove­ment in FEV1 when added to Symdeko. We think Gala­pa­gos need­ed to cross 5% to even have a hope of an ar­gu­ment here but re­al­is­ti­cal­ly would need to get a ~10% ben­e­fit to re­al­ly be con­sid­ered a com­pet­i­tive threat. We think the door is clos­ing on Gala­pa­gos, which is look­ing less and less like­ly to be able to pull out a triple com­bo that could even hope to match Ver­tex’s, much less beat it.

And while Gala­pa­gos is pro­ceed­ing with a study of its triple ther­a­py (da­ta due in the next quar­ter), its big part­ner Ab­b­Vie $AB­BV has opt­ed out of a sec­ond triple study that had been con­tem­plat­ed, leav­ing Gala­pa­gos “re­view­ing the fu­ture of its CF col­lab­o­ra­tion with Ab­b­Vie.”

Ab­b­Vie al­ready pulled out of one al­liance with Gala­pa­gos, sur­ren­der­ing its in­ter­est in fil­go­tinib, which Gilead picked up. The bond can’t be too strong now. Ab­b­Vie paid Gala­pagis $40 mil­lion up­front to part­ner on CF, with more than $300 mil­lion in mile­stones on the ta­ble. And Ab­b­Vie has walked away from much more than that with­out a sec­ond thought.

An­a­lysts — par­tic­u­lar­ly some of the heavy­weights that have long been lined up on Ver­tex’s side — are like­ly to see this as an­oth­er vin­di­ca­tion of their star play­er as the un­chal­lenged leader in CF.  Just a few weeks ago Pro­teosta­sis was brushed aside as it tried to of­fer some com­pe­ti­tion.

But the mar­ket wasn’t hav­ing it — then or now.

Piet Wiger­inck

Thurs­day af­ter­noon Ver­tex shares shot up 9% in af­ter-mar­ket trad­ing as in­vestors sa­vored the idea that the big biotech had been left well out in front, with an undis­put­ed lead as it pur­sues its own triplets. Gala­pa­gos, mean­while, plunged 17% on the news.

But they’re forg­ing ahead, in a fash­ion.

“The PEL­I­CAN tri­al is the first to eval­u­ate GLPG2737 as a C2 cor­rec­tor in CF pa­tients on top of Orkam­bi and showed CFTR on-tar­get ac­tiv­i­ty with GLPG2737 in com­bi­na­tion with Orkam­bi,” said Dr. Piet Wiger­inck, chief sci­en­tif­ic of­fi­cer of Gala­pa­gos. “We have ini­ti­at­ed dos­ing in the FAL­CON tri­al, in which we aim to eval­u­ate high­er ex­po­sures of GLPG2737 in CF pa­tients and fur­ther un­der­stand the po­ten­tial syn­er­gis­tic ef­fect of GLPG2737 on top of our own dual com­bi­na­tion com­pounds.”

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.

Covid-19 roundup: EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund; Bei­jing ar­rests ex-Bio­gen staffer who flew while in­fect­ed

For months now, the US government has doled out unprecedented grants to vaccine developers in hopes of speeding the completion of a Covid-19 candidate, even if that meant putting hundreds of millions or billions behind efforts that ultimately failed. Now, the European Union may do the same.

The EU is planning to use a $2.7 billion rainy day fund to make advance purchases of vaccine candidates, Reuters reports. The news comes a day after the Trump Administration reportedly settled on the five finalists for its Operation Warp Speed, all of whom will get significant funding and other US assistance to finish testing and scale up their vaccine candidates.

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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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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.

Doug Throckmorton speaks via video conference to the Senate Finance Committee, June 2, 2020 (Andrew Caballero-Reynolds, AP Images)

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

During a Senate Committee on Finance hearing Tuesday, officials from the FDA responded to criticism from senators and a new report from the Government Accountability Office (GAO) on its oversight of foreign drug manufacturers.

The hearing follows FDA’s move to halt most foreign inspections in March as a result of the coronavirus disease (COVID-19) pandemic.

Much of the criticism centered on the agency’s practice of giving foreign facilities advanced notice of inspections while most domestic surveillance inspections are unannounced, as well as US reliance on foreign drug manufacturing.