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.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

A new study points to $6.5B in pub­lic sup­port build­ing the sci­en­tif­ic foun­da­tion of Gilead­'s remde­sivir. Should that be re­flect­ed in the price?

By drug R&D standards, Gilead’s move to repurpose remdesivir for Covid-19 and grab an emergency use authorization was a remarkably easy, low-cost layup that required modest efficacy and a clean safety profile from just a small group of patients.

The drug OK also arrived after Gilead had paid much of the freight on getting it positioned to move fast.

In a study by Fred Ledley, director of the Center for Integration of Science and Industry at Bentley University in Waltham, MA, researchers concluded that the NIH had invested only $46.5 million in the research devoted to the drug ahead of the pandemic, a small sum compared to the more than $1 billion Gilead expected to spend getting it out this year, all on top of what it had already cost in R&D expenses.

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Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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