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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; 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.

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Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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