Glob­al syn­di­cate backs $400M ge­nomics R&D play in Ire­land as WuXi NextCODE ex­tends its reach in­to Eu­rope

The big push to trans­late fresh mounds of ge­nomics da­ta in­to new meds got a sig­nif­i­cant boost to­day as an in­ter­na­tion­al syn­di­cate of in­vestors from the US, Chi­na, Ire­land and Sin­ga­pore backed Wuxi NextCODE’s plan to add a ma­jor Eu­ro­pean se­quenc­ing ini­tia­tive and hub-build­ing project to their glob­al net­work.

The tech out­fit is mak­ing 3-year-old Ge­nomics Med­i­cine Ire­land a sub­sidiary, with fi­nan­cial back­ing tot­ting up to $400 mil­lion to see through an ef­fort to se­quence the genomes of 400,000 res­i­dents in Ire­land — about 10% of the pop­u­la­tion — in search of in­sights in­to the way spe­cif­ic genes in­flu­ence dis­ease.

In­clud­ed in this project is a ge­nomics ac­cel­er­a­tor look­ing to help spur a life sci­ences hub that they be­lieve can grow in­to some­thing along the lines of San Diego. And the Ire­land Strate­gic In­vest­ment Fund is putting up $70 mil­lion of the ini­tial $225 mil­lion bud­get with an eye to di­rect­ly cre­at­ing hun­dreds of jobs — with more to fol­low if they can ramp up the hub.

That’s a tall or­der. Ire­land has some biotechs, but its in­volve­ment in the in­dus­try is large­ly cen­tered on man­u­fac­tur­ing and its rep as a glob­al cor­po­rate tax haven. What­ev­er be­comes of the hub dream, though, big se­quenc­ing ef­forts have at­tract­ed the at­ten­tion of a broad swathe of bio­phar­ma play­ers, in­clud­ing Am­gen and Re­gen­eron, with GSK re­cent­ly jump­ing in­to a col­lab­o­ra­tion with 23andMe.

Along­side the Ire­land project, WuXi NextCODE put to­geth­er a $200 mil­lion C round — just a lit­tle more than a year af­ter it added $240 mil­lion from the Se­ries B.

The trans­glob­al fi­nan­cial syn­di­cate around this WuXi deal says a lot about the con­nec­tions that can com­mand large sums for mar­quee plans like this.

US-based Arch Ven­ture Part­ners, which has close ties to Ge Li’s glob­al ops at Shang­hai-based WuXi, linked up with the ear­ly-stage in­vestors at Po­laris, Sin­ga­pore’s Temasek and Chi­na’s Yun­feng Cap­i­tal and Se­quoia Cap­i­tal to back the play. And they have the mon­ey to make a host of star­tups a re­al­i­ty if the ini­tia­tive de­liv­ers on plans to cre­ate a hub built around ad­vanced AI, new tech and R&D.

“The suc­cess of this fi­nanc­ing round is an en­dorse­ment of our strat­e­gy to cre­ate the lead­ing glob­al plat­form for us­ing the genome to im­prove the lives of peo­ple and pa­tients every­where,” said Rob Brain­in, CEO of WuXi NextCODE. “This phase of our growth has a dis­tinct­ly Irish fo­cus to it, and we are cre­at­ing in Ire­land the world’s pre­mier genome dataset as a unique­ly pow­er­ful en­gine both for trans­form­ing how we dis­cov­er new drugs, as well as for bring­ing new di­ag­nos­tics, risk screens and oth­er tools and ser­vices to the in­di­vid­ual pa­tients.”

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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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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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.

IPO track­er: 2021 gets start­ed with a flur­ry of new of­fer­ings

A global pandemic couldn’t slow down what turned out to be a record year for biotech IPOs. With the calendar turning toward 2021, the Endpoints News team is prepped to track each new filing this year, and the outcome. We’re off to another hot start at least.

Below, you’ll find the companies that have filed to go public, in addition to those that have already priced. Through the first two business weeks of January, there have already been 9 biotechs that have filed or priced, and the number is only expected to grow. We’ll keep the tracker updated as it does.

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.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Roche amps up its bis­pe­cif­ic at­tack on Eylea with more PhI­II da­ta — but just how threat­en­ing is it?

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.