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.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.