Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115M and a high-pro­file Chi­nese part­ner

For two months, as the nov­el coro­n­avirus swelled from a few ear­ly cas­es tied to a Wuhan mar­ket to a glob­al epi­dem­ic, most of the world’s fo­cus and dol­lars have flowed to­ward emer­gency ini­tia­tives: build­ing vac­cines at a record pace, pluck­ing ex­per­i­men­tal an­tivi­rals out of freez­ers to see what sticks and im­mu­niz­ing mice for new an­ti­bod­ies.

Now a new and well-fund­ed col­lab­o­ra­tion be­tween Har­vard and a top Chi­nese re­search in­sti­tute will play the long game. In a 5-year, $115 mil­lion ini­tia­tive backed by Chi­na Ever­grande Group, re­searchers from the Har­vard Med­ical School, Har­vard T.H. Chan School of Pub­lic Health and Guangzhou In­sti­tute for Res­pi­ra­to­ry Health will study the virus in an ef­fort to de­vel­op ther­a­pies against in­fec­tions by the nov­el coro­n­avirus, known as SARS-CoV-2, and to pre­vent new ones.

The Chi­nese side of the ini­tia­tive is led by Zhong Nan­shan, head of the Chi­nese 2019-nCoV Ex­pert Task­force and the sci­en­tist who iso­lat­ed the SARS virus in 2003. He is al­so di­rec­tor-gen­er­al of the Chi­na State Key Lab­o­ra­to­ry of Res­pi­ra­to­ry Dis­eases.

“Har­vard Med­ical School is unique­ly po­si­tioned to con­vene ex­perts in vi­rol­o­gy, in­fec­tious dis­ease, struc­tur­al bi­ol­o­gy, pathol­o­gy, vac­cine de­vel­op­ment, epi­demi­ol­o­gy, and pub­lic health to con­front this rapid­ly evolv­ing cri­sis,” George Da­ley, dean of the Har­vard Med­ical School, said in a state­ment.

The ini­tia­tive will fo­cus on five ar­eas. That in­cludes de­vel­op­ing tests for rapid di­ag­no­sis, vac­cines, an­tivi­ral treat­ments to short­en the du­ra­tion of the dis­ease and mit­i­gate symp­toms, and oth­er treat­ments for pa­tients with se­vere dis­ease. Re­searchers will al­so try to un­der­stand how the body in­ter­acts with the virus. The hope is that they can find bio­mark­ers that will tell doc­tors if the in­fec­tion is wors­en­ing or will lead to life-threat­en­ing com­pli­ca­tions.

These ar­eas rep­re­sent the con­stel­la­tion of needs and un­knowns for a virus pub­lic health of­fi­cials in­creas­ing­ly fear will reach pan­dem­ic lev­els, and could be­come an an­nu­al in­fec­tion like the flu. Al­though the virus may yet dis­si­pate, ex­perts have em­pha­sized the need for long-term fund­ing that can im­prove readi­ness for fu­ture out­breaks, a need Har­vard un­der­scored in its an­nounce­ment.

The “re­sponse needs to be glob­al, rapid, and dri­ven by the best sci­ence,” Har­vard provost Alan Gar­ber said. “The lessons we learn from this out­break should en­able us to re­spond to in­fec­tious dis­ease emer­gen­cies more quick­ly and ef­fec­tive­ly in the fu­ture.”

Di­ag­no­sis has proven to be a con­tin­u­al chal­lenge through­out the virus’ spread. In Wuhan and the sur­round­ing Hubei province, the num­ber of pa­tients re­port­ing symp­toms rapid­ly out­stripped the sup­ply of nu­cle­ic acid test­ing kits used to con­firm the pres­ence of a virus. De­lays in di­ag­no­sis meant de­lays in quar­an­tine and treat­ment.

At the be­hest of Chi­nese doc­tors, of­fi­cials moved to CT scans to de­tect pneu­mo­nia, a symp­tom of the in­fec­tion, and then lat­er us­ing the test­ing kits as con­fir­ma­tion. But some in­fect­ed pa­tients show up neg­a­tive in CT scans, and as the virus has spilled out be­yond Chi­na’s bor­ders, how to test pa­tients in the fastest and most ac­cu­rate man­ner has be­come an is­sue of glob­al con­cern and a ma­jor point of dis­cus­sion at the World Health Or­ga­ni­za­tion and the US Cen­ter for Dis­ease Con­trol.

Har­vard has not said what forms of treat­ments they will in­ves­ti­gate. Thus far, most of the treat­ments used are an­tivi­rals orig­i­nal­ly de­vel­oped for oth­er pur­pos­es – in­clud­ing remde­sivir, the Gilead drug orig­i­nal­ly de­vel­oped for Ebo­la and Mar­burg virus, and lopinavir, an HIV drug – but doc­tors have flung a wide range of spec­u­la­tive ther­a­pies hop­ing to see what sticks. That in­cludes plas­ma treat­ments, an­ti­bod­ies oth­er coro­n­avirus pa­tients de­vel­oped in re­sponse to the virus and a tra­di­tion­al Chi­nese rem­e­dy drawn from ex­tracts of For­syth­iae fruc­tus. The ear­li­est drugs de­vel­oped specif­i­cal­ly for the virus are at least 5 months away from clin­i­cal tri­als.

Vac­cines ap­pear clos­er, with Mod­er­na and the NIH gun­ning for a clin­i­cal tri­al to start in the spring. How­ev­er, that us­es a tech­nol­o­gy that has yet to pro­duce an ap­proved vac­cine. Oth­er ef­forts, such as Glax­o­SmithK­line’s and Clover’s new part­ner­ship, are us­ing more tra­di­tion­al ap­proach­es but have longer time­lines.

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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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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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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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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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.

Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.