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.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Tae Han Kim, Samsung Biologics CEO (SeongJoon Cho/Bloomberg via Getty Images)

Sam­sung Bi­o­log­ics nets $330M+ deal from As­traZeneca ahead of 'Su­per Plan­t' con­struc­tion

Just a few weeks after announcing plans to construct a $2 billion “Super Plant,” Samsung Biologics is keeping its foot on the gas.

The Korean CDMO has inked a $330.8 million manufacturing contract with AstraZeneca, the companies announced Monday evening, providing the British drugmaker the ability to expand production capabilities in the Asia market. Per terms of the deal, the partnership could be increased to $545.6 million.

Francesco De Rubertis

Medicx­i's David Grainger and Francesco De Ru­ber­tis pump €200M in­to six com­pa­nies and what they say is a first-of-its kind fund

In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them.

Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures. That team kept advising Index on their life sciences portfolio even after they spun out to form their own firm in the middle of 2016.

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Scripps reach­es $10M set­tle­ment with gov­ern­ment over al­le­ga­tions NIH grants weren't prop­er­ly ac­count­ed for

Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland announced late last week.

Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks. As part of the settlement, Scripps has agreed to pay $10 million.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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Anthony Fauci (AP Images)

A press of­fi­cer de­parts An­tho­ny Fau­ci’s NI­AID af­ter his un­mask­ing as a hard-right Covid mis­in­for­ma­tion troll

William Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases for the last 13 years.

That ended Monday morning when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with incendiary rhetoric and spread misinformation in the midst of a pandemic.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.