As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coro­n­avirus orig­i­nat­ing out of Wuhan spreads to South Ko­rea, Italy and Iran, stok­ing al­ready in­tense fears of a pan­dem­ic, Glax­o­SmithK­line has found an­oth­er pair of trust­ed hands to place its ad­ju­vant sys­tem. Chi­na’s Clover Bio­phar­ma­ceu­ti­cals will add the ad­ju­vant to its pre­clin­i­cal, pro­tein-based vac­cine can­di­date against SARS-CoV-2.

Thomas Breuer

Clover, which is based in the in­land city of Cheng­du, boasts of a plat­form dubbed Trimer-Tag that pro­duces co­va­lent­ly-trimer­ized fu­sion pro­teins. Its can­di­date, COVID-19 S-Trimer, re­sem­bles the vi­ral spike (S)-pro­tein found in the virus.

Thomas Breuer, CMO of GSK Vac­cines, praised the re­search as “cut­ting edge” and their pro­pos­al promis­ing.

Ear­li­er this month the phar­ma gi­ant put out word that it’s mak­ing its plat­form avail­able to a net­work of in­ves­ti­ga­tors af­fil­i­at­ed with CEPI, the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tion in Oslo.

“The use of an ad­ju­vant is of par­tic­u­lar im­por­tance in a pan­dem­ic sit­u­a­tion since it may re­duce the amount of vac­cine pro­tein re­quired per dose, al­low­ing more vac­cine dos­es to be pro­duced and there­fore con­tribut­ing to pro­tect more peo­ple,” Breuer said in a state­ment.

There’s no time­line on when their can­di­date might be ready for a clin­i­cal tri­al, let alone be­com­ing com­mer­cial­ly avail­able. But Clover said it has “one of the largest in-house, com­mer­cial-scale cGMP bio­man­u­fac­tur­ing ca­pa­bil­i­ties in Chi­na,” which would al­low it to rapid­ly scale up pro­duc­tion of a new vac­cine.

Where­as doc­tors in Chi­na and around the world have had some suc­cess treat­ing Covid-19 pa­tients with un­proven but seem­ing­ly ef­fec­tive ther­a­pies — from HIV drugs to a malar­ia med to oth­er ex­per­i­men­tal an­tivi­rals — the plight of Wuhan has demon­strat­ed how the sheer size of the pa­tient pop­u­la­tion can over­whelm med­ical sys­tems and leave many be­hind. These fears are ex­ac­er­bat­ed by the up­dates pour­ing in from Iran, where 50 new deaths have been re­port­ed in one city, as well as Ko­rea, whose case­load has surged to over 800 in a mat­ter of days. Vac­cines re­main the Holy Grail.

Aside from the more tra­di­tion­al ap­proach, CEPI is al­so back­ing new ef­forts to de­vel­op an mR­NA vac­cine, which would hi­jack the cell’s ma­chin­ery and coax the body to make its own anti­gens that then kick up an im­mune re­sponse. Both CEPI part­ner Cure­Vac and Mod­er­na, work­ing with the NIH, have in­di­cat­ed that they will be ready for hu­man test­ing ear­ly this sum­mer — a much faster pace al­beit for a much new­er tech­nol­o­gy.

The abil­i­ty to mass man­u­fac­ture any suc­cess­ful mR­NA vac­cines that emerge, though, still re­mains in ques­tion and the NIH has plead­ed with large drug­mak­ers to step up.

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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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.

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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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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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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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.)