With eyes on an IPF fran­chise, Gala­pa­gos push­es sec­ond can­di­date in­to a dose-find­ing study

While the proof-of-con­cept re­sults for Gala­pa­gos’ sec­ond id­io­path­ic pul­monary fi­bro­sis can­di­date didn’t turn up quite as much ex­cite­ment as its lead can­di­date, the Bel­gian biotech says it’s enough to push for­ward with a dose-find­ing study.

The Phase II study as­sessed GLPG1205 in 68 IPF pa­tients over 26 weeks. Vol­un­teers were al­lowed to con­tin­ue their stan­dard of care, in­clud­ing nintedanib and pir­fenidone. While the ear­ly study “was not pow­ered to show sta­tis­ti­cal sig­nif­i­cance,” ac­cord­ing to the com­pa­ny, those in the treat­ment arm showed a small­er forced vi­tal ca­pac­i­ty (FVC) de­cline from base­line than those on a place­bo — 34 mL, com­pared to 76 mL in the place­bo arm.

Re­searchers saw no “rel­e­vant safe­ty sig­nals” in those who took the treat­ment on top of pir­fenidone. How­ev­er, those who took it with nintedanib ex­pe­ri­enced high-grade treat­ment-emer­gent ad­verse events, though Gala­pa­gos didn’t spec­i­fy what they were.

For those who took the drug alone, the most fre­quent­ly re­port­ed side ef­fects were gas­troin­testi­nal dis­or­ders, es­pe­cial­ly nau­sea.

In a proof-of-con­cept con­duct­ed years ago, Gala­pa­gos’ lead can­di­date, zir­i­tax­e­s­tat, in­creased FVC by 8mL, com­pared to a place­bo group which saw a mean de­cline from base­line of 87 mL. Still, with its eyes on an IPF fran­chise, Gala­pa­gos is lin­ing up GLPG1205 as a po­ten­tial suc­ces­sor to zir­i­tax­e­s­tat.

Gala­pa­gos’ stock $GLPG was up 3.48% on Tues­day, at $126.88 a share.

“Keep­ing in mind the lim­i­ta­tions of this ear­ly clin­i­cal study, the PIN­TA study with GLPG1205 is a pos­i­tive tri­al,” To­by Ma­her, a Uni­ver­si­ty of South­ern Cal­i­for­nia Keck School of Med­i­cine pro­fes­sor, said in a state­ment. “…While we need to un­der­stand more about long-term tol­er­a­bil­i­ty of the drug, the PIN­TA re­sults war­rant fur­ther in­ves­ti­ga­tion.”

GLPG1205 takes a dif­fer­ent ap­proach than zir­i­tax­e­s­tat, which was a fo­cal point in a re­cent $5 bil­lion li­cens­ing deal with Gilead. Zir­i­tax­e­s­tat in­hibits au­to­tax­in — an emerg­ing IPF tar­get due to its role in gen­er­at­ing lysophos­pha­tidic acid, which pro­motes in­flam­ma­tion and fi­bro­sis.

Piet Wiger­inck

GLPG1205, on the oth­er hand, is a small mol­e­cule that an­tag­o­nizes GPR84.

“This ad­di­tion­al nov­el mode of ac­tion may com­ple­ment the an­ti-fi­brot­ic ap­proach­es with­in our ex­pand­ing IPF port­fo­lio,” Gala­pa­gos CSO Piet Wiger­inck said in a state­ment.

Bridge Bio­ther­a­peu­tics al­so has an au­to­tax­in in­hibitor for IPF, which for­mer part­ner Boehringer In­gel­heim dropped last month over tox­i­c­i­ty con­cerns. Safe­ty wor­ries al­so caused Bio­gen to pull the plug on its Phase II IPF pro­gram last year, which it picked up from the Stromedix buy­out. Fi­bro­Gen is cur­rent­ly in Phase III with its own IPF ri­val.

Next up, GLPG1205 is head­ed for a Phase IIb dose-find­ing tri­al. The com­pa­ny says it’s sub­mit­ting the full Phase II re­sults to an up­com­ing med­ical con­fer­ence.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

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Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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José Baselga, AstraZeneca cancer chief (Brent N. Clarke/FilmMagic via Getty Images)

As­traZeneca's Calquence nabs an­oth­er win against Im­bru­vi­ca, but Eli Lil­ly is on its heels

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.