Sanofi, Glax­o­SmithK­line hit with a ma­jor de­lay on Covid-19 vac­cine pro­gram as their first jab flops in old­er adults

Hours af­ter Pfiz­er and BioN­Tech won the back­ing of an FDA pan­el for their mR­NA vac­cine, Sanofi and GSK an­nounced that their close­ly watched pro­gram to de­vel­op an ad­ju­vant­ed vac­cine to com­bat Covid-19 had hit a ma­jor set­back.

The com­pa­nies an­nounced ear­ly Fri­day that they were de­lay­ing their de­vel­op­ment pro­gram for an ad­ju­vant­ed re­com­bi­nant pro­tein-based Covid-19 vac­cine af­ter it failed among adults old­er than 49 in the study.

The re­searchers not­ed a “low im­mune re­sponse in old­er adults like­ly due to an in­suf­fi­cient con­cen­tra­tion of the anti­gen.”

The col­lab­o­ra­tors, who had been hop­ing to launch a piv­otal Phase III this month, are now plan­ning a Phase IIb study of a re­vised vac­cine with an im­proved anti­gen for­mu­la­tion. They plan to get that 2-shot study start­ed in Feb­ru­ary, com­par­ing it to an es­tab­lished vac­cine on the mar­ket. The move will force a de­lay on launch­ing sup­plies of the vac­cine from H1 un­til the 4th quar­ter of 2021, at best, af­ter some of­fi­cials in Op­er­a­tion Warp Speed ex­pect to see the end of the pan­dem­ic in the US.

GSK and Sanofi had pro­ject­ed get­ting hun­dreds of mil­lions of dos­es of this vac­cine out to world mar­kets, rep­re­sent­ing a large por­tion of the vac­cine dos­es the world would need to fight the pan­dem­ic. The com­pa­nies had signed a deal to work with the WHO on eq­ui­table dis­tri­b­u­tion of their vac­cine, of­fer­ing hope of a vac­cine among the world’s less af­flu­ent coun­tries. Their vac­cine de­mand­ed a slow­er ap­proach to de­vel­op­ment, but uti­lized what many be­lieved was a more re­li­able tech­nol­o­gy that could de­liv­er vac­cine in bulk around the world. Now, it ap­pears like­ly that Pfiz­er/BioN­Tech and Mod­er­na will get ap­provals in the near term, as As­traZeneca faces ques­tions about the low­er ef­fi­ca­cy it had seen in its late-stage study.

Any set­back like this threat­ens to length­en the time it takes to van­quish the virus as the first ap­proved vac­cines are like­ly to be in short sup­ply for some time. It al­so will ac­cel­er­ate the vir­tu­al rev­o­lu­tion now un­der­way in the vac­cine in­dus­try, as tra­di­tion­al tech makes way for a faster and ev­i­dent­ly more re­li­able mR­NA ap­proach.

Sanofi and GSK, two of the world’s lead­ing vac­cine mak­ers, are stay­ing in the race, even if they’ve fall­en well be­hind the lead­ers.

Thomas Tri­om­phe

“We have iden­ti­fied the path for­ward and re­main con­fi­dent and com­mit­ted to bring­ing a safe and ef­fi­ca­cious COVID-19 vac­cine. Fol­low­ing these re­sults and the lat­est en­cour­ag­ing new pre­clin­i­cal da­ta, we will now work to fur­ther op­ti­mize our can­di­date to achieve this goal,” said Thomas Tri­om­phe, ex­ec­u­tive vice pres­i­dent and head of Sanofi Pas­teur. “No sin­gle phar­ma com­pa­ny can make it alone; the world needs more than one vac­cine to fight the pan­dem­ic.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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