Franz-Werner Haas, CureVac CEO (Thomas Kienzle/AFP via Getty Images)

'No rea­son to slow down any­thing here': Cure­Vac plans to march on with Covid-19 vac­cine af­ter piv­otal fail­ure

The day af­ter Cure­Vac re­vealed its mR­NA vac­cine failed a piv­otal tri­al, crush­ing the com­pa­ny’s stock, a group of an­a­lysts tuned in­to the com­pa­ny call with vari­a­tions of the same ques­tion: What’s next for CVn­CoV?

Cure­Vac’s shares $CVAC were down near­ly 49% on Thurs­day morn­ing, af­ter an­nounc­ing an in­ter­im vac­cine ef­fi­ca­cy of just 47% against Covid-19 dis­ease of any sever­i­ty. The com­pa­ny blamed its ef­fi­ca­cy is­sues on emerg­ing vari­ants, ar­gu­ing that the vac­cine’s late en­try left re­searchers in an “in­creas­ing­ly chal­leng­ing vari­ant-rich en­vi­ron­ment,” with 13 strains cir­cu­lat­ing, CEO Franz-Wern­er Haas said on a call with in­vestors Thurs­day.

Out of 134 Covid cas­es as­sessed in the in­ter­im analy­sis, 124 were se­quenced to iden­ti­fy the vari­ant caus­ing the in­fec­tion, and on­ly one case was due to the orig­i­nal SARS-CoV-2 virus that cir­cu­lat­ed the globe for much of 2020, Haas stressed.

Sea­mus Fer­nan­dez

The com­pa­ny al­so used the call to high­light pre­clin­i­cal da­ta from CV2CoV, the sec­ond-gen­er­a­tion vac­cine it’s work­ing on with Glax­o­SmithK­line. In an­i­mal stud­ies, that can­di­date in­duced an­ti­body lev­els 10 times high­er than CVn­CoV at peak lev­el af­ter six weeks.

Guggen­heim’s Sea­mus Fer­nan­dez asked the ques­tion that like­ly float­ed to the top of every­one’s minds: “Can you just help us un­der­stand which pro­gram you’re more mo­ti­vat­ed to move for­ward with?”

Haas quick­ly re­spond­ed that a repri­or­i­ti­za­tion is not in the fu­ture.

“There is no rea­son to slow down any­thing here,” he said. “Not with re­gard to the build­ing out of our man­u­fac­tur­ing net­work, or to slow down the process with re­gards to CVn­CoV. That’s the pri­ma­ry prod­uct can­di­date, close to the fin­ish line.”

Al­though the study wasn’t sta­tis­ti­cal­ly pow­ered to read out ef­fi­ca­cy da­ta from sep­a­rate sub­pop­u­la­tions, in­ter­im chief de­vel­op­ment of­fi­cer Ul­rike Gnad-Vogt said on the call that trends sug­gest ef­fi­ca­cy in younger pop­u­la­tions, and in the most preva­lent of the 13 strains de­tect­ed in the study.

Ul­rike Gnad-Vogt

More than half of cas­es (57%) were caused by “vari­ants of con­cern,” ac­cord­ing to the com­pa­ny, while most oth­ers were caused by “less ex­plored” vari­ants like Lamb­da (C.37) first iden­ti­fied in Pe­ru or B.1.621 first found in Colom­bia. Of the to­tal 134 cas­es ob­served in the study, 119 were in peo­ple 60 years and younger, and 15 were in peo­ple over 60.

Cure­Vac ex­pects a fi­nal analy­sis in the next two to three weeks to con­firm these age- and strain-re­lat­ed trends.

When an­a­lysts asked Cure­Vac to break down the ef­fi­ca­cy num­bers for “vari­ants of con­cern,” Gnad-Vogt re­spond­ed: “It is pre­ma­ture to con­clude about this to­day. We need to go for the fi­nal analy­sis to ac­crue suf­fi­cient cas­es to draw more sta­tis­ti­cal­ly ro­bust con­clu­sions.”

If what Cure­Vac’s say­ing is true, and vari­ants van­quished what would have been an oth­er­wise ef­fec­tive vac­cine, the im­pli­ca­tion is that oth­ers are be­ing sim­i­lar­ly im­pact­ed, though we’ve seen lit­tle ev­i­dence of that.

A ma­jor­i­ty of the 124 cas­es Cure­Vac se­quenced were found to be caused by the Al­pha strain, or B.1.1.7, which was first iden­ti­fied in the UK. How­ev­er, Mod­er­na and Pfiz­er have both said their vac­cines work just fine against the B.1.1.7 vari­ant, with Mod­er­na re­leas­ing a study in Jan­u­ary that showed no sig­nif­i­cant im­pact on neu­tral­iz­ing titers against that vari­ant com­pared to pri­or ones.

Zhiqiang Shu

Beren­berg’s Zhiqiang Shu dug deep­er in­to this the­o­ry, ask­ing if Cure­Vac will draw a con­clu­sion on the vac­cine’s ef­fi­ca­cy against the Al­pha strain in par­tic­u­lar, and whether sci­en­tists could com­pare it side-to-side with oth­er mR­NA vac­cines.

Gnad-Vogt gave a half-an­swer, re­spond­ing: “We will con­tin­ue to the fi­nal analy­sis, and that may al­low us to get a bet­ter un­der­stand­ing, de­pend­ing on the num­ber of cas­es caused by the al­pha strain, about the strain-spe­cif­ic ef­fi­ca­cy. As I said al­ready, as of to­day, a firm con­clu­sion is not pos­si­ble.”

When asked about the time­line of the com­pa­ny’s rolling sub­mis­sion with the EMA, Haas said: “It’s quite clear that we need to pro­vide the da­ta and the fi­nal analy­sis, be­fore there is any es­ti­ma­tion. Be­cause what we can see in this chang­ing en­vi­ron­ment … with all the dif­fer­ent vari­ants com­ing in… it’s quite hard to es­ti­mate.”

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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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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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.

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.

(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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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.