Covid-19 roundup: Kate Bing­ham to lead UK task­force; Fed­er­al judge to Shkre­li: You’re not go­ing to save the world, stay in prison

Kate Bing­ham Crick

A top biotech ven­ture cap­i­tal­ist has been named to chair a UK gov­ern­ment task­force on de­vel­op­ing and eq­ui­tably dis­trib­ut­ing a vac­cine.

Kate Bing­ham, man­ag­ing part­ner of SV Health Ven­tures, will lead the task­force, help­ing co­or­di­nate ef­forts across in­dus­try, acad­e­mia and gov­ern­ment. Those ef­forts are now backed by £250 mil­lion ($303 mil­lion) in com­mit­ments from the UK gov­ern­ment.

As one of five man­ag­ing part­ners at SV, Bing­ham found­ed the £250 mil­lion De­men­tia Dis­cov­ery Fund five years ago. She has al­so at times been a voice for a change in bio­phar­ma, in 2016 pen­ning an open let­ter even­tu­al­ly signed by dozens of sci­en­tists and ex­ec­u­tives pil­lo­ry­ing a biotech for host­ing a par­ty that used women to woo male clients.

The task­force, an­nounced at the end of last month, al­so in­cludes not­ed im­mu­nol­o­gist John Bell and ex­ec­u­tives from Well­come Trust and As­traZeneca. As­traZeneca is lead­ing the UK’s prin­ci­pal vac­cine ef­fort, man­u­fac­tur­ing a vac­cine de­vel­oped at Ox­ford, with the promise of giv­ing the coun­try ear­ly ac­cess to the vac­cine should it prove ef­fec­tive.

World sum­mit to play host to vac­cine and treat­ment fight

The sim­mer­ing fight over ac­cess to ex­ist­ing and even­tu­al Covid-19 drugs and vac­cines will get an­oth­er are­na to­day.

Of­fi­cials from every coun­try will meet via link to­day for a sum­mit that is wide­ly ex­pect­ed to cen­ter on a sin­gle is­sue: A vol­un­tary patent pool where com­pa­nies and re­search in­sti­tutes could place their Covid-19 in­ven­tions, al­low­ing oth­er coun­tries to make cheap ver­sions. Al­though vol­un­tary, the pool could put pres­sure on vac­cine and drug de­vel­op­ers to make their in­tel­lec­tu­al prop­er­ty ac­ces­si­ble.

The res­o­lu­tion is ex­pect­ed to be ap­proved, but with soft­er word­ing af­ter push­back from coun­tries with ma­jor phar­ma­ceu­ti­cal com­pa­nies, in­clud­ing the US, the UK and Switzer­land, The Guardian re­port­ed. A sim­i­lar de­bate emerged 20 years ago as the first AIDS drugs be­came avail­able, lead­ing to a de­c­la­ra­tion from the World Trade Or­ga­ni­za­tion to reaf­firm the rights of coun­tries in some sit­u­a­tions to cir­cum­vent patents for es­sen­tial med­i­cines.

Gilead end­ing tri­als on Covid-19

Three months af­ter they start­ed test­ing remde­sivir in Chi­na, Gilead is end­ing its re­main­ing clin­i­cal tri­als for the Covid-19 an­tivi­ral, Reuters re­port­ed. They will re­port­ed­ly wind down by the end of the month.

The two open-la­bel tri­als have en­rolled over 8,000 pa­tients. The yawn­ing num­ber that at­tract­ed crit­ics, who said the drug­mak­er was pulling pa­tients from ran­dom­ized con­trolled tri­als that could yield da­ta faster, but Gilead said was de­signed to as­sure greater ac­cess.

Now, per Reuters, hos­pi­tals are con­cerned the end of the tri­als will cut off ac­cess to the drug.

Al­though with the da­ta from a ran­dom­ized NIH tri­al, the drug has now been au­tho­rized by the FDA – in the­o­ry ob­vi­at­ing part of the need for clin­i­cal tri­als. Doc­tors have raised con­cerns about how the Trump ad­min­is­tra­tion has dis­trib­uted the drug so far. First, they did not an­nounce cri­te­ria or a plan for which hos­pi­tals would re­ceive the drug, and the first ship­ments over­looked some hos­pi­tals with a high num­ber of pa­tients and gave to hos­pi­tals with few pa­tients. Lat­er, HHS an­nounced state gov­ern­ments would be re­spon­si­ble for de­cid­ing which hos­pi­tals in their state would re­ceive the drug, but they did not out­line how they would de­cide how many dos­es to give to each state.

Those dos­es are from Gilead, which has pledged to do­nate 1.5 mil­lion dos­es of remde­sivir – about 40% of which are for pa­tients in the US. The com­pa­ny has said it is ac­tive­ly ramp­ing man­u­fac­tur­ing.

Fed­er­al judge to Shkre­li: You’re not go­ing to save the world, stay in prison

Last month, Mar­tin “Phar­ma Bro” Shkre­li post­ed a pa­per on­line with an un­usu­al ad­den­dum.

“I am ask­ing for a brief fur­lough (3 months) to as­sist in re­search work on Covid-19,” Shkre­li wrote in a PDF pub­lished to the oth­er­wise emp­ty site of a com­pa­ny he found­ed in 2015, Pros­pero Phar­ma. “As a suc­cess­ful two-time bio­phar­ma en­tre­pre­neur, hav­ing pur­chased mul­ti­ple com­pa­nies, in­vent­ed mul­ti­ple new drug can­di­dates, filed nu­mer­ous INDs and clin­i­cal tri­al ap­pli­ca­tions, I am one of the few ex­ec­u­tives ex­pe­ri­enced in ALL as­pects of drug de­vel­op­ment from mol­e­cule cre­ation and hy­poth­e­sis gen­er­a­tion.”

At the time, few in the in­dus­try were im­pressed with ei­ther the qual­i­ty of Shkre­li’s sci­en­tif­ic pa­per — which de­tailed an ef­fort to screen com­pounds for ones ac­tive to Covid-19, a prac­tice al­ready com­mon­place — nor his ca­pac­i­ty to make unique con­tri­bu­tions in a coro­n­avirus fight that was al­ready en­list­ing some of the coun­try’s top sci­en­tists and biotech ex­ec­u­tives.

And now, it seems, a judge was sim­i­lar­ly unim­pressed with his plea.

In a 9-page rul­ing Sat­ur­day, US Dis­trict Judge Kiyo Mat­sumo­to sided with pros­e­cu­tors who de­scribed Shkre­li’s plea for re­lease as in­dica­tive of the  “delu­sion­al self-ag­gran­diz­ing be­hav­ior” that land­ed him in jail to be­gin with.

”The court does not find that re­leas­ing Mr. Shkre­li will pro­tect the pub­lic, even though Mr. Shkre­li seeks to lever­age his ex­pe­ri­ence with phar­ma­ceu­ti­cals to help de­vel­op a cure for Covid-19 that he would pur­port­ed­ly pro­vide at no cost,” Mat­sumo­to wrote. “In any event, Mr. Shkre­li’s self-de­scribed al­tru­is­tic in­ten­tions do not pro­vide a le­gal ba­sis to grant his mo­tion.”

Al­though the con­di­tions in some pris­ons dur­ing the pan­dem­ic have be­come the sub­ject of sig­nif­i­cant crit­i­cism, with many in­mates un­able to se­cure home trans­fers de­spite out­breaks with­in the fa­cil­i­ty and urg­ings from the Jus­tice De­part­ment, Mat­sumo­to de­ter­mined that wasn’t the case for Shkre­li, who was “healthy” and whose low-se­cu­ri­ty prison in Al­len­wood, PA has not ex­pe­ri­enced an out­break.

“De­fen­dant re­quests to be re­leased in­to, among oth­er places, an apart­ment in New York City, the epi­cen­ter of the covid-19 pan­dem­ic,” Mat­sumo­to wrote.

Shkre­li, 37, was giv­en a 7-year sen­tence in 2017 for de­fraud­ing in­vestors.

UK un­veils plan to get ear­ly ac­cess to 30 mil­lion vac­cines by Sep­tem­ber

For­get 12-18 months. The British gov­ern­ment is hop­ing to vac­ci­nate half its pop­u­la­tion by Sep­tem­ber, or 9 months af­ter the ini­tial out­break — an ag­gres­sive time­line that is among the fastest put for­ward by world lead­ers or pub­lic health of­fi­cials.

Busi­ness Sec­re­tary Alok Shar­ma said Sun­day that the gov­ern­ment would fund As­traZeneca with an ad­di­tion­al £84 mil­lion ($102 mil­lion) as part of an agree­ment that will see the British drug­mak­er give the UK 30 mil­lion dos­es by Sep­tem­ber, should it prove ef­fec­tive in tri­als over the sum­mer.

”The UK will be first to get ac­cess,” Shar­ma said. “We can al­so en­sure that in ad­di­tion to mak­ing the vac­cine avail­able to de­vel­op­ing coun­tries at the low­est pos­si­ble cost.”

The UK plan slots in­to a larg­er de­bate over how to dis­trib­ute the vac­cine when it be­comes avail­able. The US has fund­ed com­pa­nies’ vac­cine ef­forts at a larg­er scale, and have sim­i­lar­ly se­cured rights to make cer­tain or­ders as part of those fund­ed agree­ments. As­traZeneca, which is pro­duc­ing a vac­cine de­vel­oped at Ox­ford Uni­ver­si­ty, had al­ready an­nounced that the UK would get ear­ly time­line.

These plans have so far not sat well with oth­er world lead­ers. Last week, Sanofi CEO Paul Hud­son caused a stir among his board and in the French gov­ern­ment when he told Bloomberg that the US would get “the right to the largest pre-or­der.” And UN­AIDS and Ox­fam re­leased a let­ter from cur­rent and for­mer world lead­ers, call­ing for a “peo­ple’s vac­cine” that was ac­ces­si­ble “first for front-line work­ers, the most vul­ner­a­ble peo­ple, and for poor coun­tries with the least ca­pac­i­ty to save lives.”

The UK–As­traZeneca plan is of course con­tin­gent on the vac­cine prov­ing ef­fec­tive — no sure thing. A study in non-hu­man pri­mates showed the vac­cine ap­peared to elic­it an im­mune re­sponse and pro­tect the mon­keys from se­ri­ous lung dam­age, but it did not en­tire­ly stop in­fec­tion. The de­vel­op­ers are now in Phase I, but have said they plan to move in­to a com­bined Phase II/III this month. Pub­lic health of­fi­cials have warned a vac­cine could take 12-18 months, or sig­nif­i­cant­ly longer, and that some vac­cine can­di­dates are like­ly to fail in the clin­ic.

The new fund­ing in­cludes £38 mil­lion pounds for the erec­tion “rapid-de­ploy­ment fa­cil­i­ty” to be­gin man­u­fac­tur­ing over the sum­mer, be­fore a larg­er fac­to­ry, the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre, opens at Ox­ford next sum­mer.

Eu­rope nears remde­sivir okay

The US au­tho­rized it, Japan has ap­proved it, and now Eu­rope may soon clear it as well.

The head of the EMA, Gui­do Rasi, said that an ini­tial au­tho­riza­tion for remde­sivir could come in the next few days, Reuters re­ports. The Gilead an­tivi­ral was shown in an NIH tri­al last month to re­duce the time it takes pa­tients to re­cov­er from Covid-19.

The EMA be­gan their re­view process for remde­sivir a day af­ter the NIH re­sults be­came pub­lic on April 29, but in­di­cat­ed the process could take time — a con­trast with the FDA, who was ru­mored to be near­ing an emer­gency use au­tho­riza­tion the day the tri­al came out and ul­ti­mate­ly is­sued one two days lat­er. The drug is al­ready au­tho­rized on the con­ti­nent to be giv­en un­der com­pas­sion­ate use.

Okay­ing remde­sivir, though, will on­ly be half the bat­tle. Ac­quir­ing and dis­tri­b­u­tion will be the rest. In the US, that process has been marred by con­fu­sion, as the fed­er­al gov­ern­ment failed to de­tail a cri­te­ria for which hos­pi­tals got ac­cess and an in­ad­e­quate sup­ply left some doc­tors scram­bling. Gilead, though, has been work­ing since the ear­ly days of the out­break to scale up pro­duc­tion and have ac­cel­er­at­ed their ef­forts since the NIH tri­al.

Last week, the Cal­i­for­nia com­pa­ny signed deals with 5 gener­ics man­u­fac­tur­ers in Pak­istan and In­dia, al­though those con­tracts are large­ly for dis­tri­b­u­tion in low and mid­dle in­come coun­tries.

Vir Biotech­nol­o­gy pub­lish­es an­ti­bod­ies in Na­ture

Vir Biotech­nol­o­gy, the George Scan­gos-led in­fec­tious dis­ease com­pa­ny, pub­lished in Na­ture the de­tails for the mon­o­clon­al an­ti­body they are bring­ing in­to the clin­ic for Covid-19 this sum­mer.

The pa­per, pub­lished ini­tial­ly as a preprint last month, is the first by one of the three ma­jor com­pa­nies de­vel­op­ing mon­o­clon­al an­ti­bod­ies against Covid-19 to de­tail their lead can­di­date. It de­scribes an an­ti­body called S309 that neu­tral­izes both SARS-CoV-2, the virus that caus­es Covid-19, and the SARS virus that caused a ma­jor out­break in East Asia and oth­er parts of the world in 2002 and 2003. The idea is that by tar­get­ing an epi­tope — a part of the spike pro­tein — that is present in mul­ti­ple dif­fer­ent virus­es, you’re like­ly tar­get­ing an es­sen­tial part that won’t change as the virus mu­tates. Vir will bring two ver­sions of the an­ti­body for­ward, one with ed­its to make it last longer and one with ed­its to make it both longer last­ing and gen­er­ate a stronger T cell re­sponse

Vir, along with Ab­cellera and Re­gen­eron, are ex­pect­ed to en­ter the clin­ic with their an­ti­bod­ies this sum­mer, test­ing them both as a pro­phy­lax­is and as a pro­tec­tion against Covid-19. An­ti­bod­ies from Re­gen­eron and Hum­abs — now a sub­sidiary of Vir — were the two drugs that proved ef­fec­tive last year against Ebo­la.

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