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.

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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