Covid-19 roundup — Re­gen­eron zooms in on cock­tail; BioN­Tech shares sky­rock­et on quick Pfiz­er al­liance

On the morn­ing af­ter the Bay Area or­dered res­i­dents of six coun­ties to “shel­ter in place” amid vary­ing lev­els of lock­down around the world, here are the lat­est in­dus­try up­dates:

— Lead­ing the hunt for an­ti­bod­ies that can neu­tral­ize the coro­n­avirus that caus­es Covid-19, Re­gen­eron said it’s as­sem­bled a large pool of can­di­dates — hun­dreds of an­ti­bod­ies — from which it will se­lect two to make a “cock­tail treat­ment.” While the an­ti­bod­ies are be­ing se­lect­ed, the com­pa­ny will get its Ve­lociMab plat­form in place to pre­pare cell lines for clin­i­cal-scale pro­duc­tion. Re­gen­eron en­vi­sions en­ter­ing hu­man stud­ies in a cou­ple months, with a goal to pro­duce “hun­dreds of thou­sands of pro­phy­lac­tic dos­es per month” by the end of sum­mer. All of this comes a lit­tle over a month af­ter Re­gen­eron first threw its name in­to the coro­n­avirus R&D hat. Fol­low­ing this same ap­proach has led the biotech to an Ebo­la reg­i­men that best­ed three oth­er treat­ments. In ad­di­tion to de­vel­op­ing an­ti­bod­ies that can serve both as treat­ment and as a pro­phy­lax­is be­fore peo­ple are ex­posed to SARS-CoV-2 (an ap­proach Vir is al­so tak­ing), Re­gen­eron has al­so rushed its IL-6 drug Kez­vara — ap­proved for arthri­tis — in­to a late-stage tri­al test­ing its abil­i­ty to tack­le the lung in­flam­ma­tion that re­sults from the vi­ral in­fec­tion.

Ash­leigh Palmer

— Al­most a year ago Proven­tion Bio be­gan what Jef­frey Blue­stone called the “re­al hard work” on the res­ur­rect­ed di­a­betes drug teplizum­ab, dos­ing the first pa­tient with new­ly di­ag­nosed type 1 di­a­betes with the an­ti-CD3 an­ti­body. The work has just got­ten hard­er as the Covid-19 pan­dem­ic is forc­ing the biotech to tem­porar­i­ly pause ran­dom­iz­ing and treat­ing new pa­tients — while those cur­rent­ly tak­ing the ther­a­py com­plete their course. This de­lay, though, does not hin­der Proven­tion’s plan to wrap up its rolling BLA sub­mis­sion for the at-risk pop­u­la­tion by the end of the year. That was part­ly sup­port­ed by Phase II da­ta sug­gest­ing teplizum­ab de­layed di­a­betes di­ag­noses for pa­tients who ap­pear poised to de­vel­op the dis­ease. The Phase III PRO­TECT study was de­signed to see if the drug could help pa­tients who al­ready have di­a­betes — such as to low­er their de­pen­dence on in­sulin. “Our de­ci­sion was not based on any study-re­lat­ed COVID-19 in­fec­tions or oth­er safe­ty events, but rather a pre­pon­der­ance of cau­tion re­lat­ing to the on­go­ing pan­dem­ic, and our con­cern for the well-be­ing of re­cent­ly di­ag­nosed T1D pe­di­atric pa­tients and their care­givers,” CEO Ash­leigh Palmer said in a state­ment. “The de­mands on med­ical in­sti­tu­tions and their clin­i­cians dur­ing this un­prece­dent­ed glob­al cri­sis were al­so a main con­sid­er­a­tion in this de­ci­sion.”

— Shut­downs are be­com­ing more com­mon, and they’ve been fill­ing the BioTwit­ter chan­nel:

— In the year of coro­n­avirus, there’s no time to dot every i and cross every t in a bio­phar­ma deal. Ear­ly Tues­day Pfiz­er and BioN­Tech $BN­TX were ready to hitch up on one of the big mes­sen­ger RNA vac­cine pro­grams aimed at the dev­as­tat­ing spread of Covid-19. And they made it clear they were rolling ahead of any for­mal sig­na­tures on a fi­nal con­tract. Qui­et­ly re­vealed just days ago, BioN­Tech says that BNT162 should be ready to go in the clin­ic by the end of next month. It fol­lows a lead­ing mR­NA ef­fort from Mod­er­na as well as a hur­ry-up project from Cure­Vac, where the re­volv­ing door at the CEO suite is spin­ning. The col­lab­o­ra­tion work starts now, with a plan to uti­lize mul­ti­ple R&D sites across both com­pa­nies in the US and Ger­many, where BioN­Tech is based. They ex­pect to fi­nal­ize the de­tails of their part­ner­ship in the next few weeks. If there are any ba­sics in the let­ter of agree­ment, they’re not talk­ing about it yet. In the mean­time, BioN­Tech’s shares rock­et­ed up 55%.

— In the spir­it of do­na­tions, Bio­gen said its phil­an­thropic arm has com­mit­ted $10 mil­lion to sup­port Covid-19 re­lief ef­forts in the US and around the world. “We are deeply af­fect­ed by the im­pact of COVID-19 glob­al­ly and we un­der­stand the crit­i­cal im­por­tance of ac­cess to test­ing and oth­er ma­te­ri­als to sup­port health­care providers,” said CEO Michel Vounatsos, who’s now pre­sid­ing over the hard­est-hit drug­mak­er in the in­dus­try. A strat­e­gy meet­ing held at Boston Mar­riott Long Wharf has led to the in­fec­tion of 100 Bio­gen staffers and their house­hold con­tacts in Mass­a­chu­setts, where a to­tal of 197 cas­es have been re­port­ed as of Mon­day af­ter­noon — and that’s not count­ing oth­er lo­cal trans­mis­sion. In ad­di­tion to pro­vid­ing med­ical equip­ment and sup­plies to Part­ners Health­Care and sup­port­ing two lo­cal hos­pi­tals in their front line work, Bio­gen’s funds will al­so go to­ward ex­pend­ing test­ing op­tions, eas­ing the strains on med­ical sys­tems, of­fer­ing train­ing and se­cur­ing ac­cess to ne­ces­si­ties like food in places such as North Car­oli­na, where at least five Bio­gen staffers have been test­ed pos­i­tive af­ter at­tend­ing the lead­er­ship gath­er­ing.

— Amid warn­ings that peo­ple who get mild symp­toms of Covid-19 and re­cov­er are dri­ving the spread of the dis­ease, sci­en­tists at the Uni­ver­si­ty of Min­neso­ta are turn­ing their fo­cus to this par­tic­u­lar pop­u­la­tion. They are launch­ing a new clin­i­cal tri­al to see if an old malar­ia drug — chloro­quine or hy­drox­y­chloro­quine — is a bet­ter post-ex­po­sure pro­phy­lax­is than the cur­rent stan­dard of care: ob­ser­va­tion. The tri­al will en­roll 1,500 in­di­vid­u­als who have had ex­po­sure to a Covid-19 case with­in 3 days, name­ly ei­ther health­care work­ers of house­hold con­tacts. The Uni­ver­si­ty of Ox­ford is plan­ning a sim­i­lar study with 10,000 par­tic­i­pants in May. Clin­i­cians in Chi­na and Aus­tralia have re­port­ed en­cour­ag­ing re­sults treat­ing Covid-19 pa­tients with chloro­quine.

— Chi­nese sci­en­tists may now be­gin test­ing a sub­unit vac­cine de­vel­oped by the Acad­e­my of Mil­i­tary Med­ical Sci­ences in col­lab­o­ra­tion with CanSi­no Bi­o­log­ics. The Hong Kong-list­ed com­pa­ny said its can­di­date us­es a repli­ca­tion-de­fec­tive ade­n­ovirus type 5 as a vec­tor to ex­press the spike pro­tein on SARS-CoV-2. It’s al­so be­gun pre-screen­ing of healthy vol­un­teers in an­tic­i­pa­tion of the tri­al, which was green­light­ed Mon­day night. CanSi­no has pre­vi­ous­ly worked with Wei Chen, the se­nior bio­engi­neer cred­it­ed with lead­ing the re­search work, on Chi­na’s first Ebo­la vac­cine.

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

Biogen CEO Michel Vounatsos (via Getty Images)

With ad­u­canum­ab caught on a cliff, Bio­gen’s Michel Vounatsos bets bil­lions on an­oth­er high-risk neu­ro play

With its FDA pitch on the Alzheimer’s drug aducanumab hanging perilously close to disaster, Biogen is rolling the dice on a $3.1 billion deal that brings in commercial rights to one of the other spotlight neuro drugs in late-stage development — after it already failed its first Phase III.

The big biotech has turned to Sage Therapeutics for its latest deal, close to a year after the crushing failure of Sage-217, now dubbed zuranolone, in the MOUNTAIN study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,200+ biopharma pros reading Endpoints daily — and it's free.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

The ad­u­canum­ab co­nun­drum: The PhI­II failed a clear reg­u­la­to­ry stan­dard, but no one is cer­tain what that means any­more at the FDA

Eighteen days ago, virtually all of the outside experts on an FDA adcomm got together to mug the agency’s Billy Dunn and the Biogen team when they presented their upbeat assessment on aducanumab. But here we are, more than 2 weeks later, and the ongoing debate over that Alzheimer’s drug’s fate continues unabated.

Instead of simply ruling out any chance of an approval, the logical conclusion based on what we heard during that session, a series of questionable approvals that preceded the controversy over the agency’s recent EUA decisions has come back to haunt the FDA, where the power of precedent is leaving an opening some experts believe can still be exploited by the big biotech.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

A poll sug­gests vac­cine da­ta boost­ed Pfiz­er's pub­lic im­age, but oth­er da­ta point to long road ahead

For much of the pharmaceutical industry, the pandemic presented an opportunity: to prove their value to the world and turn public opinion around on a business much of the country had come to disdain.

That theory — that helping pull the country from a pandemic could neutralize years of anger over high drug prices — was put to its biggest test this month, as three different drugmakers announced data from their Covid-19 vaccines, offering the first major evidence that industry-built inoculations could turn the tide of the outbreak in the US.