President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month af­ter word first broke of the Trump Ad­min­is­tra­tion’s plan to rapid­ly ac­cel­er­ate the de­vel­op­ment and pro­duc­tion of a Covid-19 vac­cine, the White House has se­lect­ed the five vac­cine can­di­dates they con­sid­er most like­ly to suc­ceed, The New York Times re­port­ed.

Most of the names in the plan, known as Op­er­a­tion Warp Speed, will come as lit­tle sur­prise to those who have watched the last four months of vac­cine de­vel­op­ments: Mod­er­na, which was the first vac­cine to reach hu­mans and is now the fur­thest along of any US ef­fort; J&J, which has not gone in­to tri­als but re­ceived around $500 mil­lion in fund­ing from BAR­DA ear­li­er this year; the joint As­traZeneca-Ox­ford ven­ture which was grant­ed $1.2 bil­lion from BAR­DA two weeks ago; Pfiz­er, which has been work­ing with the mR­NA biotech BioN­Tech; and Mer­ck, which just en­tered the race and ex­pects to put their two vac­cine can­di­dates in­to hu­mans lat­er this year.

Paul Hud­son

No­tably ab­sent from that list is Sanofi. The French vac­cine gi­ant has worked with BAR­DA since the agency’s ear­ly days and re­ceived $30 mil­lion in fund­ing ear­li­er this year for its re­com­bi­nant DNA Covid-19 vac­cine ef­fort. The omis­sion comes af­ter CEO Paul Hud­son caused an in­ter­con­ti­nen­tal stir last month when he said that the US would get the “right to the largest pre-or­der” of their vac­cine be­cause the fed­er­al gov­ern­ment had backed the project at-risk, al­though the com­pa­ny lat­er walked back some of those com­ments.

A cou­ple oth­er much-hyped vac­cine ef­forts were left out, in­clud­ing those from No­vaVax and In­ovio. In­vestors, who had sent their stocks cloud-bound dur­ing the pan­dem­ic, quick­ly took note of their ex­clu­sion, sink­ing shares 12% and 11%, re­spec­tive­ly.

It’s pos­si­ble, though, that oth­er names may arise. Bloomberg re­port­ed late yes­ter­day that the White House had se­lect­ed 7 dif­fer­ent can­di­dates, al­though they were able to give on­ly the names of the five that the Times re­port­ed.

A for­mal an­nounce­ment is ex­pect­ed to be made lat­er this month, the New York Times re­port­ed. A spokesper­son for HHS, which over­sees the vast bulk of the gov­ern­ment’s vac­cine and drug re­sponse, de­clined to com­ment.

The new win­now­ing ap­pears to be part of the third phase of the project, which was for­mal­ly an­nounced in a press re­lease on May 15. HHS said at the time that 14 dif­fer­ent vac­cine can­di­dates had been se­lect­ed out of the 100-plus in de­vel­op­ment but, with the ex­cep­tion of bil­lion­aire physi­cian Patrick Soon-Sh­iong, none of the mak­ers of those can­di­dates said whether they were part of the project and nei­ther did the gov­ern­ment.

Ac­cord­ing to HHS, those 14 can­di­dates would then be cut down to 8 dif­fer­ent can­di­dates and, fi­nal­ly, to 3-5 can­di­dates that will pro­ceed to “large-scale ran­dom­ized tri­als.” These can­di­dates are al­so those that, in part­ner­ship with the gov­ern­ment, will go in­to large-scale man­u­fac­tur­ing be­fore they’ve been ful­ly test­ed or au­tho­rized — a cru­cial step for as­sur­ing that when a vac­cine is proven, it can al­so be rapid­ly de­ployed.

The com­pa­nies will al­so like­ly get ad­di­tion­al fund­ing, the New York Times re­port­ed, on top of the rough­ly $2.2 bil­lion al­ready al­lo­cat­ed be­tween Mod­er­na, J&J, and As­traZeneca. BAR­DA re­ceived $6.5 bil­lion un­der the CARES Act, al­though that fund is not ex­clu­sive­ly for vac­cines.

The ad­min­is­tra­tion has not pub­licly set goal­posts for the op­er­a­tion, but in late April Bloomberg quot­ed an of­fi­cial at 300 mil­lion dos­es by Jan­u­ary and most state­ments have giv­en a sim­i­lar range. NI­AID chief An­tho­ny Fau­ci said on Tues­day “by the be­gin­ning of 2021 we hope to have a cou­ple of hun­dred mil­lion dos­es.”

Ken Fra­zier Mer­ck

That time­line would be or­ders of mag­ni­tude faster than the or­di­nary pace of vac­cine de­vel­op­ment, which can of­ten take at least a decade, and some vi­rol­o­gist and vac­cine de­vel­op­ers have ques­tioned how at­tain­able it is. That group in­cludes Mer­ck CEO Ken Fra­zier, who told FT that a 12-18 month time­line for a vac­cine was “very ag­gres­sive” and “not some­thing I would put out there that I would want to hold Mer­ck to.”

Much of the work to reach that goal is al­ready un­der­way. As­traZeneca’s agree­ment with BAR­DA called for the com­pa­ny to pro­vide 300 mil­lion dos­es to the US, start­ing in Oc­to­ber, and Mod­er­na signed an agree­ment with Swiss CMO Lon­za to pro­duce a bil­lion dos­es per year, with the first batch­es com­ing in Ju­ly.

The se­lect­ed can­di­dates cov­er at least three dif­fer­ent tech­nolo­gies, in­clud­ing mR­NA from Mod­er­na and BioN­Tech and ade­n­ovi­ral vec­tors from J&J and As­traZeneca. Mer­ck has two can­di­dates, one that us­es a vec­tor called VSV and an­oth­er that us­es a measles virus vec­tor. It was not clear which can­di­date was se­lect­ed by the gov­ern­ment, al­though the VSV one has al­ready been backed by $38 mil­lion from BAR­DA and the agency put sev­er­al hun­dred mil­lion dol­lars be­hind an Ebo­la vac­cine from Mer­ck that used the same plat­form.

The fur­thest along of the ef­forts are As­traZeneca and Mod­er­na, both of which are now in Phase II. Fau­ci said in an in­ter­view with JA­MA on Tues­day that Mod­er­na could move in­to a glob­al, 30,000-per­son Phase III tri­al next month.

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

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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Petro Terblanche, Afrigen Biologics managing director (Kristin Palitza/picture-alliance/dpa/AP Images)

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

NEW YORK — When vaccines from high-income countries did not arrive in Africa, a local WHO-backed company decided to take the matter into its own hands.

The South Africa-based company Afrigen Biologics and Vaccines has developed the continent’s first mRNA Covid-19 vaccine that will enter clinical trials in early 2023. Afrigen developed the shot by copying publicly available sequencing information about Moderna’s shot after the biotech and Pfizer refused assistance.

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Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Covid-19 roundup: Mod­er­na sends in EUA for bi­va­lent teen boost­er; US trim­ming Pfiz­er/BioN­Tech do­na­tions

Though Moderna’s bivalent vaccine to counter the Omicron variant has cleared the initial hurdles in getting FDA authorization, the vaccine maker is moving on to the next step.

On Twitter, the company announced on Friday that it has filed a EUA for its bivalent vaccine for use in adolescents aged 12 through 17 and for smaller children aged six through 11.