Franz-Werner Haas, CureVac CEO (AP Images)

Cure­Vac spins a ma­jor set­back on their mR­NA Covid vac­cine in­to an ad­van­tage in the mar­ket wars to come

Af­ter strug­gling — and large­ly fail­ing — to make a case for their dis­ap­point­ing Covid-19 vac­cine, Cure­Vac is throw­ing in the tow­el and tak­ing a shot at com­ing up with some­thing vi­able for the glob­al mar­ket when coun­tries shift from pan­dem­ic to en­dem­ic vac­ci­na­tion cam­paigns.

Tues­day morn­ing the Ger­man mR­NA play­er — ac­com­pa­nied by a rep­re­sen­ta­tive of Glax­o­SmithK­line, which is al­lied on the work — ripped the ban­dage off a fes­ter­ing wound and re­treat­ed from an mR­NA vac­cine that fell short of the 50% pro­tec­tion mark, drop­ping their ap­pli­ca­tion for au­tho­riza­tion in Eu­rope and ax­ing a con­tract to de­liv­er more than 400 mil­lion dos­es of the jab.

At the time Cure­Vac ex­ecs re­vealed the da­ta, they in­sist­ed that the vac­cine of­fered enough pro­tec­tion to make it a valu­able ad­di­tion in a world still reel­ing from an un­con­trolled virus. While vac­ci­na­tion lev­els have been ris­ing in af­flu­ent coun­tries, there’s still a mas­sive de­mand for dos­es around the globe.

That’s not a vi­able po­si­tion any­more, though, Cure­Vac CEO Franz-Wern­er Haas con­ced­ed in an in­vestor call Tues­day morn­ing. Ac­cord­ing to Haas, “the com­plex­i­ty of the da­ta we have” shift­ed any like­ly de­ci­sion on the part of Eu­ro­pean reg­u­la­tors back in­to 2022.

By that time, he adds, the de­mand for vac­cines will be shift­ing from first-gen vac­cines to sec­ond-gen so­lu­tions. And that’s where they want to fo­cus their at­ten­tion.

Shares of Cure­Vac $CVAC slid more than 5% af­ter the news hit.

“While we ac­knowl­edge that we can­not be part of the first wave of vac­cines any more,” not­ed the CEO, they can make a big dif­fer­ence for the sec­ond gen­er­a­tion re­sponse, when peak de­mand is fol­lowed by the on­go­ing re­quire­ments of con­trol­ling a virus that most ex­perts be­lieve will nev­er be ful­ly ex­tin­guished.

That’s about as pos­i­tive a spin as Cure­Vac could muster at this point. Two mR­NA vac­cines from Pfiz­er/BioN­Tech and Mod­er­na have proven rel­a­tive­ly safe and high­ly ef­fec­tive — at least in the short term — for com­bat­ing the virus. Oth­er jabs, from J&J and As­traZeneca, have suf­fered from safe­ty fears, but still of­fer a shot at pro­tec­tion for large swathes of the world’s pop­u­la­tion.

All of them have per­formed sig­nif­i­cant­ly bet­ter than Cure­Vac’s vac­cine, which Haas ear­li­er claimed suf­fered from the vari­ants now spread­ing around the globe.

The set­back at Cure­Vac, once con­sid­ered a ma­jor play­er in the mR­NA are­na, al­so re­vives ques­tions about the tech­nol­o­gy it us­es. As End­points News’ Ja­son Mast has re­port­ed, Cure­Vac used un­mod­i­fied RNA in its vac­cine in search of a ma­jor im­pact. BioN­Tech and Mod­er­na both used mod­i­fied RNA. And while the ju­ry is still out on that point, Cure­Vac was op­er­at­ing from a wob­bly tech stance that has drawn con­sid­er­able at­ten­tion.

In ad­di­tion, both BioN­Tech/Pfiz­er and Mod­er­na are work­ing on their own sec­ond-gen pro­grams, while de­vel­op­ing more glob­al man­u­fac­tur­ing ca­pac­i­ty for bet­ter dis­tri­b­u­tion. That gives them a large ad­van­tage in a ri­val­ry that will force the lag­gard Cure­Vac to do some­thing re­al­ly re­mark­able with a new vac­cine, or face be­ing forced to stay on the side­line.

This is al­so just the lat­est in a long string of vac­cine fail­ures. Sanofi and Mer­ck, for ex­am­ple, were both were forced to ac­knowl­edge their fail­ures, with Sanofi push­ing de­vel­op­ment out un­til 2022 and Mer­ck shift­ing its at­ten­tion to the an­tivi­ral mol­nupi­ravir. That pro­vid­ed BioN­Tech and Mod­er­na with a re­mark­able ad­van­tage, which they clear­ly in­tend to cap­i­tal­ize on.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

So — that pig-to-hu­man trans­plant; Po­ten­tial di­a­betes cure reach­es pa­tient; Ac­cused MIT sci­en­tist lash­es back; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We’re incredibly excited to welcome Beth Bulik, seasoned pharma marketing reporter, to the team. You can find much of her work in our new Marketing channel — and in her weekly newsletter, Endpoints PharmaRx, which will launch in early November. Add it to your subscriptions here.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.