Covid-19 roundup: Top an­a­lyst: Re­gen­eron EUA like­ly this week — un­less Trump takes a turn for worse; UK says less than half of res­i­dents will be vac­ci­nat­ed

With Re­gen­eron’s Covid-19 an­ti­body cock­tail be­ing used to treat the high­est-pro­file pa­tient on the plan­et, one top an­a­lyst ex­pects an EUA could be on the hori­zon.

SVB Leerink’s Ge­of­frey Porges sent a note to in­vestors ear­ly Mon­day morn­ing at­tempt­ing to parse through what the use of REGN-CoV2 to al­le­vi­ate Pres­i­dent Don­ald Trump’s symp­toms means for the com­pa­ny. Giv­en that the ther­a­py was used at all, Porges es­ti­mates that the FDA was al­ready re­view­ing its EUA ap­pli­ca­tion and that the au­tho­riza­tion could come “in a mat­ter of days.”

Porges notes that the Pres­i­dent is tak­ing the high­er dose of REGN-CoV2 and is like­ly one of the first pa­tients tak­ing it in com­bi­na­tion with both remde­sivir and dex­am­etha­sone. This sug­gests that Trump not on­ly had a high vi­ral load but al­so a low im­mune re­sponse. Ear­ly pub­lic da­ta from REGN-COV2 stud­ies showed that the high­er dose was bet­ter at re­duc­ing vi­ral load, but worse in re­duc­ing symp­toms.

All in­di­ca­tions, how­ev­er, point to a more pos­i­tive read­out for REGN-CoV2 than what had been pub­licly dis­closed. The de­ci­sion to ad­min­is­ter the cock­tail in such a promi­nent case would not have been made with­out Re­gen­eron and the FDA be­ing more bull­ish than they’ve let on, Porges writes:

As­sum­ing Re­gen­eron has seen much more pre-clin­i­cal and clin­i­cal da­ta than has been dis­closed, and then as­sum­ing that the White House med­ical staff and their ad­vis­ers, as well as the FDA, had ac­cess to sum­maries of all that da­ta when the treat­ment of PO­TUS was con­tem­plat­ed, then their de­ci­sion to use the prod­uct can be con­strued as a pos­i­tive in­di­ca­tor about the drug’s clin­i­cal pro­file. Fur­ther­more, the de­ci­sion could be val­i­dat­ed if the FDA grants REGN an EUA for REGN-CoV2 in the next few days – this would sug­gest that the agency was re­view­ing the ap­pli­ca­tion al­ready, and had reached a suf­fi­cient de­gree of com­fort to en­dorse us­ing it in such ex­tra­or­di­nary cir­cum­stances.

Lat­er Mon­day morn­ing, Re­gen­eron CSO George Yan­copou­los re­vealed in a CN­BC in­ter­view that the biotech has al­so of­fered its reg­i­men — which is al­so be­ing test­ed as a pre­ven­tion for those who’ve been ex­posed to the coro­n­avirus — to De­mo­c­ra­t­ic pres­i­den­tial can­di­date Joe Biden and his team.

None of this comes with­out sub­stan­tial risk, how­ev­er. Most no­tably, Re­gen­eron is risk­ing its rep­u­ta­tion that Trump will make a re­cov­ery from Covid-19, Porges says, and a fail­ure will raise sig­nif­i­cant ques­tions.

“If PO­TUS does bad­ly, will that cause physi­cians, con­sumers and in­vestors to lose con­fi­dence in REGN-CoV2?” he writes. “If there are un­usu­al com­pli­ca­tions of his COVID, are they blamed on REGN-CoV2?”

Ul­ti­mate­ly, Re­gen­eron like­ly de­cid­ed that the ben­e­fits out­weigh those risks. — Max Gel­man

Less than half of UK cit­i­zens will get a vac­cine, gov­ern­ment says

Not every­one in the UK will re­ceive a Covid-19 vac­cine — most­ly just those at risk, the gov­ern­ment’s vac­cine task force head Kate Bing­ham told the Fi­nan­cial Times.

If a vac­cine is ap­proved, the UK plans to in­oc­u­late less than half its pop­u­la­tion, or rough­ly 30 mil­lion of 67 mil­lion peo­ple, ac­cord­ing to the FT. Bing­ham called the idea of vac­ci­nat­ing every­one “mis­guid­ed.”

Kate Bing­ham

“There’s go­ing to be no vac­ci­na­tion of peo­ple un­der 18. It’s an adult-on­ly vac­cine, for peo­ple over 50, fo­cus­ing on health work­ers and care­home work­ers and the vul­ner­a­ble,” she told the FT.

Ac­cord­ing to in­ter­im ad­vice post­ed by the UK’s Joint Com­mit­tee on Vac­ci­na­tion and Im­mu­ni­sa­tion last week, care home res­i­dents and work­ers would be pri­or­i­tized first. Next comes those old­er than 80 and health and so­cial care work­ers. From there, pa­tients would be ranked by age.

Bing­ham said in­oc­u­lat­ing a broad­er por­tion of the pop­u­la­tion might make sense if a vac­cine proves to be 95% ef­fec­tive. But for now, the fo­cus will be on those most at risk of se­vere ill­ness.

David Nabar­ro, spe­cial en­voy to the WHO, al­so told the FT that the Covid-19 vac­cine won’t be avail­able to just any­one. “We’re not fun­da­men­tal­ly us­ing the vac­cine to cre­ate pop­u­la­tion im­mu­ni­ty, we’re just chang­ing the like­li­hood peo­ple will get harmed or hurt. It will be strate­gic.”

The EMA an­nounced last week that it be­gan a rolling re­view of As­traZeneca’s Covid-19 vac­cine with Ox­ford Uni­ver­si­ty. The agency’s hu­man med­i­cines com­mit­tee is al­ready look­ing at the can­di­date’s first batch of da­ta, in an ef­fort to speed up the ap­proval process. — Nicole De­Feud­is 

In­dia’s hop­ing for 500 mil­lion vac­cine dos­es by Ju­ly

Harsh Vard­han

In­dia’s health min­is­ter Harsh Vard­han said the coun­try is look­ing for up to 500 mil­lion Covid-19 vac­cine dos­es by Ju­ly.

That would be enough to cov­er 250 mil­lion of In­dia’s 1.3 bil­lion res­i­dents, ac­cord­ing to a Reuters re­port. Vard­han told the news or­ga­ni­za­tion that In­dia’s gov­ern­ment is fo­cused on “fair and eq­ui­table” dis­tri­b­u­tion of the dos­es. The health min­istry is ex­pect­ed to present a list of those who will be pri­or­i­tized to re­ceive the vac­cine, like front­line health work­ers, this month.

At more than 6.5 mil­lion Covid-19 cas­es, In­dia has the world’s sec­ond high­est case­load. Over 75,000 cas­es were re­port­ed in the last 24 hours, ac­cord­ing to the World Health Or­ga­ni­za­tion’s tal­ly. The coun­try’s death toll is near­ing 102,000.

In a rush to se­cure dos­es, the Serum In­sti­tute of In­dia en­tered col­lab­o­ra­tions with No­vavax and Spy­Biotech, whose can­di­dates en­tered Phase III and Phase I/II tri­als in Sep­tem­ber, re­spec­tive­ly. The Serum In­sti­tute al­so struck a deal with As­traZeneca for 1 bil­lion dos­es. While As­traZeneca’s vac­cine tri­als are still on hold in the US due to a po­ten­tial­ly se­ri­ous ad­verse event suf­fered by a British pa­tient, In­dia has al­lowed the biotech to re­sume test­ing there. — Nicole De­Feud­is 

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

In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Covid-19 roundup: An mR­NA play­er gets a boost out of the lat­est round of an­i­mal da­ta; Phase­Bio pulls the plug on treat­ment tri­al

The big tell for CureVac $CVAC is coming up with a looming early-stage readout on their mRNA Covid-19 vaccine in the clinic. But for now they’ll make do with an upbeat assessment on the preclinical animal data they used to get into the clinic.

Researchers for the German biotech say they got the high antibody titers and T cell activation they were looking for, lining up a hamster challenge to demonstrate — in a simple model — that the vaccine could protect the furry creatures. Like the other mRNA vaccines, the drug sends instructions to spur cells to decorate themselves with the distinctive spike on the virus to elicit an immune response.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: FDA anoints Gilead­'s remde­sivir as the Covid-19 treat­ment win­ner, hand­ing down full ap­proval — de­spite some deep skep­ti­cism

Seven months into the Covid-19 pandemic, the race to develop a treatment for the disease that’s proved to be the biggest health crisis in a century has an officially designated winner: Gilead. And they’re picking up the prize — worth billions in peak sales — despite a major study that concluded the drug was no help in reducing the number of people who die from the virus.

The FDA handed down a thumbs-up for remdesivir, the company announced Thursday afternoon, as the drug becomes the first fully approved treatment for Covid-19 in the US. Remdesivir, to be marketed as Veklury, will come with a label for treatment in adults and children older than 12 in Covid-19 cases that require hospitalization.

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Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.