George Scangos, Vir CEO (BIO via YouTube)

Covid-19 roundup: New preprint sug­gests Omi­cron sub-vari­ant can evade Vir an­ti­body; BioN­Tech-backed non­prof­it un­der­mined WHO eq­ui­ty ef­forts — re­port

Af­ter Omi­cron be­gan spread­ing across the world, it quick­ly be­came clear that Vir-GSK’s an­ti­body sotro­vimab would be the on­ly FDA-ap­proved Covid-19 mon­o­clon­al an­ti­body treat­ment to re­main ef­fec­tive against the new im­mune-eva­sive vari­ant. And it is now the on­ly such treat­ment used in the US, caus­ing mass short­ages.

But a new preprint, re­leased late Wednes­day night by promi­nent Co­lum­bia Uni­ver­si­ty HIV re­searcher and an­ti­body ex­pert David Ho, sug­gests doc­tors may not be able to use sotro­vimab for long. The an­ti­body isn’t ef­fec­tive at neu­tral­iz­ing BA.2, the Omi­cron sub­vari­ant that is gain­ing ground in Eu­rope, the US and much of the globe, the re­searchers found.

They wrote it was 27 times less ef­fec­tive at neu­tral­iz­ing BA.2 than against the orig­i­nal strain of the virus.

The preprint prompt­ed Vir to put out a press re­lease at 1:24 am Thurs­day morn­ing — 10:24 PT — say­ing that their own lab analy­ses sug­gest sotro­vimab “re­tains neu­tral­iz­ing ac­tiv­i­ty” against BA.2.

Vir said its own preprint would be post­ed in the “com­ing week.” It’s dif­fi­cult to know how to in­ter­pret the du­el­ing da­ta un­til then, and it may con­tin­ue to be dif­fi­cult to dis­cern. Dif­fer­ent labs can come up with dif­fer­ent neu­tral­iza­tion re­sults for an­ti­bod­ies, de­pend­ing on how the an­ti­body is ex­pressed and test­ed.

No­tably, the Ho lab al­so found in De­cem­ber that sotro­vimab lost ef­fi­ca­cy against a dif­fer­ent sub­vari­ant of Omi­cron, while a Uni­ver­si­ty of Wash­ing­ton lab that works di­rect­ly with Vir found the op­po­site.

An­ti­bod­ies with re­duced neu­tral­iza­tion can still pre­vent se­vere Covid-19, de­pend­ing on how siz­able the re­duc­tion is. And the oth­er meth­ods now in­creas­ing­ly em­ployed to keep pa­tients out of the hos­pi­tal — the IV an­tivi­ral remde­sivir and the oral pills from Mer­ck and Pfiz­er — don’t tar­get the coro­n­avirus spike pro­tein and are like­ly to re­main ef­fec­tive against the new vari­ant.

Even if the new Ho re­sults prove out, they al­so do pro­vide one note of op­ti­mism: Bebtelovimab, Eli Lil­ly’s next gen­er­a­tion Covid an­ti­body, re­tains po­tent ac­tiv­i­ty against all Omi­cron sub-vari­ants.— Ja­son Mast

BioN­Tech-backed non­prof­it al­leged­ly un­der­mined WHO tech trans­fer hub, per re­port

WHO’s ef­forts to boost mR­NA vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties in African coun­tries were un­der­mined by a non­prof­it group last sum­mer with ties to BioN­Tech, a new re­port claims.

The kENUP Foun­da­tion al­leged­ly tried to dis­suade African gov­ern­ments from par­tic­i­pat­ing in the pro­grams by say­ing the project was doomed, The BMJ re­port­ed Wednes­day. Per doc­u­ments ob­tained by the pub­li­ca­tion dat­ed last Au­gust, the non­prof­it ar­gued the WHO Vac­cine Tech­nol­o­gy Trans­fer Hub should be “ter­mi­nat­ed im­me­di­ate­ly” in or­der to not in­fringe on mR­NA vac­cine patents.

In­stead, kENUP pro­mot­ed a BioN­Tech-backed plan to ship ready-made mR­NA fac­to­ries in sea con­tain­ers, to be staffed by BioN­Tech em­ploy­ees, the re­port says. The group al­so al­leged­ly tried to de­vise a new reg­u­la­to­ry path­way to make it eas­i­er to ap­prove vac­cines made in such fac­to­ries, which at times went against lo­cal gov­ern­ment reg­u­la­tions.

The re­port comes amidst the back­drop of some African biotechs, name­ly Afrigen Bi­o­log­ics, at­tempt­ing to re­pro­duce the mR­NA vac­cines us­ing pub­licly avail­able in­for­ma­tion. Last month, Afrigen suc­cess­ful­ly re­con­struct­ed Mod­er­na’s shot — both the mR­NA as­pect and the full for­mu­la­tion — with plans to launch clin­i­cal tri­als on the con­ti­nent lat­er this year.

In ad­di­tion, the emer­gence of the Omi­cron vari­ant last fall reignit­ed a de­bate around glob­al vac­cine eq­ui­ty, with phar­ma in­dus­try crit­ics slam­ming com­pa­nies and rich na­tions for fo­cus­ing ef­forts on boost­er shots while many in Africa have yet to re­ceive their first vac­cine dose. More than 10 bil­lion dos­es have been ad­min­is­tered glob­al­ly, but on­ly about 350 mil­lion in Africa.

The WHO and CO­V­AX-backed tech­nol­o­gy trans­fer hub is aim­ing to re­duce that gap, with Afrigen and the Bio­vac In­sti­tute — an­oth­er South African com­pa­ny — shoot­ing to make around 500 mil­lion dos­es per year thanks in part to the hub.

And BioN­Tech and Mod­er­na have launched sep­a­rate ef­forts to build their own fac­to­ries in African coun­tries: Mod­er­na an­nounced in Oc­to­ber it would spend $500 mil­lion to build a vac­cine plant on the con­ti­nent, while BioN­Tech the same month signed mem­o­ran­dums of un­der­stand­ing with Rwan­da and Sene­gal to build pro­duc­tion fa­cil­i­ties start­ing this year. — Max Gel­man

No­var­tis, Mol­e­c­u­lar Part­ners sub­mit EUA for DARPin an­tivi­ral can­di­date

No­var­tis on Thurs­day re­quest­ed an EUA for enso­vibep, a DARPin an­tivi­ral ther­a­peu­tic can­di­date to treat Covid-19, its part­ner Mol­e­c­u­lar Part­ners said in a state­ment.

This sub­mis­sion is based on da­ta from the Phase 2 por­tion of the EM­PA­THY study, a ran­dom­ized, place­bo-con­trolled study which en­rolled 407 symp­to­matic pa­tients in­fect­ed with SARS-Cov-2. The com­pa­nies said one month ago that the pri­ma­ry end­point in the tri­al was met with a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in vi­ral load over eight days, com­pared to place­bo, for all three dos­ing arms.

The place­bo arm with 99 pa­tients had a to­tal of five hos­pi­tal­iza­tions, two of whom died due to wors­en­ing of Covid and one pa­tient had an ER vis­it on­ly. In the 301 pa­tients treat­ed with enso­vibep, there were four events, in­clud­ing two hos­pi­tal­iza­tions and two ER vis­its. But no deaths oc­curred in any of the pa­tients treat­ed with enso­vibep. — Zachary Bren­nan

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Hank Safferstein, Generian CEO

Astel­las sub­sidiary to part­ner with Pitts­burgh up­start in search for 'un­drug­gable' pro­teins

As Astellas continues its drive to build out its gene therapy portfolio and capabilities, a subsidiary of the Japanese pharma company has entered into a collaboration with a little-known Pittsburgh biotech.

Astellas-owned Mitobridge and Generian Pharmaceuticals announced on Wednesday that they will work together in a new deal for “undruggable” protein targets. Generian will net an undisclosed upfront payment and could get up to $180 million in milestones, should anything from its platform prove successful, as well as single-digit royalties on global net sales.

Adam Simpson, Icosavax CEO

Reel­ing from Covid flop, Icosavax says its RSV can­di­date passed ear­ly test. But in­vestors need some more con­vinc­ing

Three months separated from a disappointing readout of its Covid-19 vaccine, Icosavax is back with what it calls positive topline data for a different VLP vaccine candidate — although investors aren’t impressed.

IVX-121, a vaccine candidate for respiratory syncytial virus (RSV), appeared to generate “robust” immune responses among both young and older adults, as measured by neutralizing antibodies, and appeared generally well-tolerated, Icosavax reported.

Shehnaaz Suliman, ReCode Therapeutics CEO (Photo by Jennifer Leahy)

Pfiz­er, Sanofi-backed LNP out­fit goes back to the well and draws $120M for its trek to the clin­ic

A preclinical biotech touting a five-lipid drug delivery platform is looking to break out of its preclinical mold, and it just secured a sizable raise to do just that.

ReCode Therapeutics reported Wednesday morning that Leaps by Bayer and Matrix Capital Management affiliate AyurMaya co-led a Series B extension round, adding $120 million to the biotech’s previous Series B haul of $80 million. The biotech has been backed by several players in Big Pharma, notably Pfizer and Sanofi from its original Series B close last fall. And in this extension — featuring all new investors, CEO Shehnaaz Suliman tells Endpoints News — Amgen’s VC arm jumped on board.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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