CEO Nancy Stagliano (File photo, Neuron23)

Up­dat­ed: Neu­ron23 launch­es with $113M fi­nanc­ing and eyes dead set on De­nali and Bio­gen

A day af­ter an­nounc­ing two new funds worth $500 mil­lion, West­lake Vil­lage BioPart­ners are an­nounc­ing their lat­est com­pa­ny. And it’s a well-heeled neu­ro start­up, mak­ing a play against some of the field’s biggest tar­gets.

South San Fran­cis­co-based Neu­ron23 an­nounced Wednes­day a $113 mil­lion com­bined Se­ries A and Se­ries B and short-term plans to both take on De­nali and Bio­gen in Parkin­son’s dis­ease and pur­sue the neur­al-side of a tar­get that Bris­tol My­ers Squibb has re­cent­ly pur­sued to great suc­cess else­where in the body.

Beth Sei­den­berg

“I was very in­ter­est­ed in neu­rode­gen­er­a­tive dis­ease and ge­net­i­cal­ly val­i­dat­ed tar­gets,” West­lake man­ag­ing di­rec­tor Beth Sei­den­berg told End­points News. “And we went off, kind of around the world, [search­ing].”

What they found was Ori­ge­nis, a Ger­man AI-dri­ven small mol­e­cule dis­cov­er­er that had de­vel­oped sev­er­al can­di­dates for neu­ro­log­i­cal tar­gets.

Ac­quir­ing mol­e­cules and tech from Ori­ge­nis, Neu­ron23 is tack­ling LRRK2, the same Parkin­son’s gene at the cen­ter of the $1 bil­lion-up­front part­ner­ship Bio­gen and De­nali Ther­a­peu­tics signed this year. De­nali al­ready has a con­sid­er­able edge, with tri­als al­ready launched in both healthy vol­un­teers and Parkin­son’s pa­tients and their blood-brain bar­ri­er cross­ing tech­nol­o­gy pub­lished in top jour­nals.

Neu­ron23 thinks they can pull ahead in part by try­ing to drug not on­ly the 3% or so of Parkin­son’s pa­tients who have LRRK2 mu­ta­tions but al­so oth­ers who have a high­ly ac­tive wild-type ver­sion, said CEO Nan­cy Stagliano. They plan to put the drug in healthy vol­un­teers next year.

The com­pa­ny’s oth­er lead tar­get is TYK2, the JAK fam­i­ly pro­tein that Bris­tol My­ers re­cent­ly showed could beat Am­gen block­buster Ote­zla in a head-to-head study on pso­ri­at­ic arthri­tis. Al­though the com­pa­ny has not dis­closed which dis­eases they will go af­ter, they hope to prove that a TYK2 block­er can have as po­tent an ef­fect on neu­ro-in­flam­ma­tion as the Big Phar­ma showed it could on sys­temic in­flam­ma­tion.

Neu­ron23 joins a raft of re­cent well-backed neu­ro­science star­tups that have launched just this month, as GSK vet Min Li, for­mer Roche ex­ec George Garibal­di and At­las Ven­ture’s Bruce Booth all made sig­nif­i­cant bets in the field. Stagliano brings her own ex­pe­ri­ence in the field. Among oth­er biotechs, she pre­vi­ous­ly found­ed and ran iP­ier­ian, the com­pa­ny that Bris­tol My­ers ac­quired in 2014 for their an­ti-tau Alzheimer’s an­ti­body.

The first two tar­gets are just that — the first two, Stagliano said, and they plan to an­nounce more tar­gets and dis­eases in the near fu­ture. That po­ten­tial­ly in­cludes such neu­ro­science white whales as Alzheimer’s, she said. The trick will be just mak­ing sure not every­one runs out of the same tar­get again.

“You see this kind of awak­en­ing,” she told End­points. “We need drugs for these dis­eases, we can’t give up and we can’t all fo­cus on one bi­ol­o­gy, we need to di­ver­si­fy, we need to in­vest and we need to, again, use all the tools avail­able to us.”

West­lake and Klein­er Perkins led the Se­ries A, while Red­mile Group led the Se­ries B.

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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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.

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.

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.

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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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.