Covid-19 roundup: $71M from DoD to In­ovio; Pigs pro­vide clues on Ox­ford vac­cine; Google lends su­per­com­put­ing to an­tivi­ral hunt

In­ovio is locked in a le­gal stand­off with its con­tract man­u­fac­tur­er pre­vent­ing it from scal­ing up their vac­cine, but that hasn’t stopped the De­part­ment of De­fense from back­ing their tech­nol­o­gy.

On Tues­day, the DoD gave In­ovio a $71 mil­lion con­tract to scale up man­u­fac­tur­ing of the Cel­lec­tra de­vices that ac­com­pa­ny their vac­cines. It’s the sec­ond con­tract for a Covid-19 man­u­fac­tur­er DoD has signed this month, af­ter a $60 mil­lion deal with No­vavax on June 4. Both tranch­es came af­ter the biotechs were left off the re­port­ed list of fi­nal­ists for Trump’s Op­er­a­tion Warp Speed, al­though not every name on that list is known.

For In­ovio, the deal comes three weeks af­ter they sued their con­tract man­u­fac­tur­er VGXI, claim­ing the Penn­syl­va­nia com­pa­ny was hold­ing them “hostage.” VGXI re­fused, In­ovio al­leged, to make their vac­cine, cit­ing lack of ca­pac­i­ty, and al­so re­fused to trans­fer the tech­nol­o­gy for mak­ing their vac­cine to an­oth­er CMO, which In­ovio said they were ob­lig­at­ed to do.

The stand­off comes as oth­er com­pa­nies de­vel­op­ing Covid-19 vac­cines pre­pared plans to make hun­dreds of mil­lions or even bil­lions of dos­es to com­bat an un­prece­dent­ed glob­al cri­sis. While mak­ing the vac­cine, VGXI doesn’t pro­duce the Cel­lec­tra de­vice that goes with it.

The de­vice is a quirk of the kind of vac­cines In­ovio us­es: DNA vac­cines. Be­cause the DNA has to reach the cell nu­cle­us, doc­tors use a de­vice that sends an elec­tri­cal charge crack open the nu­cle­us and al­low the DNA to en­ter.

In­ovio’s vac­cine is now in Phase I, with plans for a Phase II/III this sum­mer. — Ja­son Mast

Pigs pro­vide clues for Ox­ford’s Covid-19 vac­cine

Ear­ly hu­man tri­als will soon give a firmer an­swer, but new da­ta from pigs sug­gest that two dos­es may be bet­ter than one for As­traZeneca and Ox­ford’s Covid-19 vac­cine.

In a preprint post­ed to­day, re­searchers at Britain’s Pir­bright In­sti­tute found that pigs who re­ceived an ini­tial in­oc­u­la­tion and then a boost­er dose 4 weeks lat­er pro­duced more neu­tral­iz­ing an­ti­bod­ies than their porcine coun­ter­parts, who re­ceived on­ly a sin­gle dose. Pir­bright, which works on in­fec­tious dis­ease in an­i­mals, was work­ing with the Jen­ner In­stiute, the Ox­ford group that de­vel­oped the vac­cine.

A promi­nent ques­tion for all vac­cines, the num­ber of dos­es re­quired holds par­tic­u­lar im­por­tance for Covid-19, where re­searchers face the un­prece­dent­ed task of try­ing to vac­ci­nate the world against a new dis­ease as quick­ly as pos­si­ble. Mer­ck, in choos­ing its vac­cine part­ners, said that it specif­i­cal­ly se­lect­ed a can­di­date that re­quired one dose be­cause it would be eas­i­er to dis­trib­ute.

As­traZeneca is now in a Phase II/III study that will ex­am­ine in part how one dose of the vac­cine com­pares to two. Their Phase I tri­al al­so asked that ques­tion, and da­ta are pend­ing. — Ja­son Mast

Google pro­vides su­per­com­put­ing pow­er for Schrödinger, No­var­tis, oth­ers to hunt an­i­tivi­rals

A few months af­ter ty­ing the knot with Google to use its cloud com­put­ing ops to de­ploy what amounts to su­per­com­put­er pow­er for its dis­cov­ery ef­forts, Schrödinger has re­worked the deal specif­i­cal­ly to widen its work on Covid-19. And Google is do­nat­ing its cloud re­sources to pro­vide Schrödinger the op­por­tu­ni­ty to ex­plore the uni­verse of chem­i­cal space for an­tivi­rals to fight Covid-19.

Work­ing with a group of al­lies that in­cludes Take­da, No­var­tis, Gilead Sci­ences, and WuXi AppTec, Schrödinger has been mod­el­ing mol­e­cules with the right pro­file, and us­ing Google Cloud to “sup­port ul­tra-large vir­tu­al screens for two of the tar­gets” they have in mind.

Google Cloud’s grant — “16 mil­lion hours of NVIDIA GPU time, which if used con­sec­u­tive­ly, would equate to 1,826 years of around-the-clock com­put­ing” — gives them the chance to screen bil­lions of mol­e­cules each week.

In turn, the de­vel­op­ers in the group will take the lead on ac­quir­ing and as­say­ing the best can­di­dates, push­ing ahead to lead op­ti­miza­tion. — John Car­roll

Pri­vate eq­ui­ty firms buy 1.2M square-foot Bris­tol My­ers Squibb cam­pus, try to flip it to on­shore drugs

As Covid-19 be­gan dis­rupt­ing glob­al trade ear­ly this spring and spurred coun­tries such as In­dia to re­strict ex­ports of drugs that could be use­ful against the virus, the Trump Ad­min­is­tra­tion be­gan talk­ing pub­licly about the need to ex­pand the US’ ca­pac­i­ty to make phar­ma­ceu­ti­cal in­gre­di­ents on­shore. That’s when a pair of pri­vate eq­ui­ty firms ap­par­ent­ly saw a fi­nan­cial op­por­tu­ni­ty.

Lin­coln Eq­ui­ties Group and H.I.G. Re­al­ty Part­ners an­nounced yes­ter­day that they have ac­quired a 1.2 mil­lion square-foot phar­ma­ceu­ti­cal cam­pus near Prince­ton, New Jer­sey from Bris­tol My­ers Squibb. They are now mar­ket­ing it in terms con­sis­tent with the ad­min­is­tra­tion’s rhetoric.

“Giv­en the cur­rent pub­lic health cri­sis, we an­tic­i­pate phar­ma­ceu­ti­cal and life sci­ences man­u­fac­tur­ers to con­sid­er ‘reshoring’ and ex­pand­ing op­er­a­tions in the U.S.,” Lin­coln pres­i­dent Joel Berg­stein said in a state­ment.

Fi­nan­cial terms of the deal were not dis­closed, but they are like­ly to be a sub­stan­tial. A mar­ket­ing brochure pre­pared by the bro­ker­age firm JLL ad­ver­tis­es that the land comes with “over $500M in­vest­ed cap­i­tal im­prove­ments.” The 1.2 mil­lion square feet in­cludes near­ly 200,000 al­ready leased to PTC Ther­a­peu­tics for gene ther­a­py re­search and man­u­fac­tur­ing. The biotech’s fi­nan­cial records in­di­cate that the deal is cost­ing them around $88 mil­lion over the next 15 years.

The ad­min­is­tra­tion has made clear, though, that there are re­wards to be had. In May, the biode­fense agency BAR­DA hand­ed out a $384 mil­lion con­tract — po­ten­tial­ly worth up to $812 mil­lion — to Phlow, a com­pa­ny that was pre­cise­ly 3 months old and run by a doc­tor-ex­ec­u­tive with lit­tle ex­pe­ri­ence in man­u­fac­tur­ing. Much of that com­pa­ny’s op­er­a­tions will be based at a for­mer Boehringer In­gel­heim plant in Rich­mond, Vir­ginia. — Ja­son Mast

An­oth­er Chi­nese vac­cine en­ters hu­man test­ing

A vac­cine de­vel­oped by the Chongqing Zhifei Bi­o­log­i­cal Prod­ucts will be the 7th Covid-19 vac­cine to en­ter hu­man test­ing out of Chi­na, Reuters re­port­ed.

The vac­cine was co-de­vel­oped by An­hui Zhifei Long­com Bio­phar­ma­ceu­ti­cal and the In­sti­tute of Mi­cro­bi­ol­o­gy of the Chi­nese Acad­e­my of Sci­ences, but the part­ners have been qui­et so far — at least in Eng­lish lan­guage out­lets — and it’s not clear what type of vac­cine they have. Large­ly, though, the coun­try’s biotechs have fo­cused on in­ac­ti­vat­ed vac­cines, in which peo­ple are giv­en a killed virus that ide­al­ly trig­gers an im­mune re­sponse. CanSi­no is al­so de­vel­op­ing an ade­n­ovirus vec­tor vac­cine. — Ja­son Mast

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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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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Covid-19 roundup: Mod­er­na sticks to Ju­ly for its Phase III as ru­mors swirl; Fol­low­ing US lead, EU buys up Covid-19 treat­ments

The Phase III might be delayed from its original early July goal, but Moderna says it will still kick off the pivotal study for what could ultimately be the first Covid-19 vaccine before the end of the month.

A day after Reuters reported that squabbling between the Cambridge biotech and government regulators had held up the trial by about two weeks, Moderna released a statement saying that they had completed enrollment of their 650-person Phase II trial and were on track to begin Phase III by the end of the month. The protocol for that study, which is meant to prove whether or not the vaccine can prevent people from becoming sick, has been finalized, they said.

Zai Lab inks Chi­na deal with Turn­ing Point with $25M up­front; Xen­cor, Atre­ca team up on bis­pecifics

Zai Lab is paying out a $25 million upfront for the rights to sell Turning Point Therapeutics’ lead drug repotrectinib in Greater China. The San Diego-based biotech is also in line for up to $151 million in milestones, along with mid-to-high teen royalties. Zai plans to add sites to the Phase II trial of the drug, which is designed to treat ROS1-positive advanced NSCLC in patients who were not previously treated with a TKI.

Sin­gu­lar fo­cus on ROR1 earns Velos­Bio $137M to fund PhI ADC and oth­er pro­grams

Years after selling Acerta to AstraZeneca for $7 billion, largely on the promise of its BTK inhibitor, Dave Johnson has once again gathered hefty financial support behind a new cancer target.

Matrix Capital Management and Surveyor Capital are leading a $137 million round for VelosBio, which has recently begun a Phase I study for its lead antibody-drug conjugate targeted against ROR1. Johnson took up the CEO post in October 2018.

Stephen Hahn, AP

Trump and Navar­ro press again for hy­drox­y­chloro­quine. Can the FDA stay in­de­pen­dent?

Tuesday morning, economist and Trump advisor Peter Navarro walked onto the White House driveway and promptly brought a political cloud back onto the FDA.

Speaking to a White House pool reporter, Navarro said that four Detroit doctors were, based on a single disputed study, filing for the FDA to again issue an emergency authorization for hydroxychloroquine, the anti-malarial pill that President Trump hyped for months as a Covid-19 treatment over the objections of his own scientists. Then, while avoiding directly calling for the FDA to OK the drug, blasted the agency. He said its decision to pull an earlier authorization “was based on bad science” and “had a tremendously negative effect” on doctors and patients.

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FDA bars the door — for now — against Mer­ck’s star can­cer drug af­ter Roche beat them to the punch

Merck has been handed a rare setback at the FDA.

After filing for the accelerated approval of a combination of their star PD-1 drug Keytruda with Eisai’s Lenvima as a first-line treatment for unresectable hepatocellular carcinoma, the FDA nixed the move, handing out a CRL because Roche beat them to the punch on the same indication by a matter of weeks.

According to Merck:

Ahead of the Prescription Drug User Fee Act action dates of Merck’s and Eisai’s applications, another combination therapy was approved based on a randomized, controlled trial that demonstrated overall survival. Consequently, the CRL stated that Merck’s and Eisai’s applications do not provide evidence that Keytruda in combination with Lenvima represents a meaningful advantage over available therapies for the treatment of unresectable or metastatic HCC with no prior systemic therapy for advanced disease. Since the applications for KEYNOTE-524/Study 116 no longer meet the criteria for accelerated approval, both companies plan to work with the FDA to take appropriate next steps, which include conducting a well-controlled clinical trial that demonstrates substantial evidence of effectiveness and the clinical benefit of the combination.

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Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Roger Tung, Concert Pharmaceuticals CEO (Concert)

Con­cert gets BTD for alope­cia drug, set­ting up a late-stage show­down with gi­ant ri­val Pfiz­er

Concert Pharmaceuticals’ path to developing a drug that treats alopecia areata has been bumpy, but the pharma company scored a win Wednesday.

The FDA granted Concert a Breakthrough Therapy Designation (BTD) for its oral Janus kinase inhibitor, named CTP-543, paving the way for a Phase III study of the drug to begin in the fourth quarter of 2020. The news follows positive Phase II results from last September, which saw the drug meet its primary endpoint in both 8 mg and 12 mg twice-daily doses.