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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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