Covid-19 roundup: Yet more dos­es of the As­traZeneca-Ox­ford vac­cine; A sec­ond ran­dom­ized hy­drox­y­chloro­quine study fails

An­oth­er gene ther­a­py com­pa­ny is of­fer­ing its fa­cil­i­ties to the Covid-19 fight.

Ox­ford Bio­med­ica, a 90s-era spin­out of Ox­ford Uni­ver­si­ty, has signed a 5-year agree­ment to help man­u­fac­ture the Covid-19 vac­cine be­ing de­vel­oped by Ox­ford Uni­ver­si­ty’s Jen­ner In­sti­tute and As­traZeneca. The deal is with the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre, a gov­ern­ment-spon­sored non-prof­it set up 2 years ago to shore up the isle’s vac­cine man­u­fac­tur­ing ca­pac­i­ty.

The part­ner­ship works be­cause of the par­tic­u­lar type of vac­cine the Jen­ner In­sti­tute it’s de­vel­op­ing. An ade­n­ovi­ral vec­tor, the vac­cine can­di­date us­es a weak­ened ver­sion of a com­mon cold-caus­ing virus to de­liv­er the gene for a coro­n­avirus in­to hu­man cells. It’s a sim­i­lar sys­tem to the one gene and cell ther­a­py com­pa­nies like Bio­med­ica or AveX­is — which last month agreed to man­u­fac­ture a vac­cine based on a sim­i­lar tech­nol­o­gy — use to de­liv­er their ther­a­pies.  Along­side its own pipeline, the UK biotech helps sup­ply the lentivi­ral vec­tors used in No­var­tis’s CAR-T treat­ment Kym­ri­ah.

Bio­med­ica first an­nounced it was work­ing with the Jen­ner In­sti­tute in ear­ly April, when they joined a con­sor­tium ded­i­cat­ed to push­ing their vac­cine for­ward. But the new agree­ment fi­nal­izes the part­ner­ship and calls for the Vac­cines Man­u­fac­tur­ing and In­no­va­tion Cen­tre to help the biotech out­fit two new man­u­fac­tur­ing sites, with an eye to­ward sat­is­fy­ing UK and EU de­mand for a vac­cine, should it prove ef­fec­tive.

Chi­nese biotech brings sec­ond an­ti­body in­to clin­ic

A week af­ter Eli Lil­ly and its biotech part­ner Ab­Cellera brought the first Covid-19 an­ti­body ther­a­py in­to the clin­ic, Shang­hai-based Jun­shi Bio­sciences has brought the sec­ond.

Jun­shi dosed their first pa­tient in Chi­na, though the com­pa­ny has its own part­ner­ship with Lil­ly and will start a US tri­al on the drug can­di­date, known as JS016, in the sec­ond quar­ter of the year. Phase I is in healthy vol­un­teers and will test safe­ty and im­muno­genic­i­ty.

Nu­mer­ous com­pa­nies, promi­nent and ob­scure, are try­ing to de­vel­op an­ti­bod­ies that can treat or pre­vent Covid-19. These lab-grown mol­e­cules mim­ic the body’s nat­ur­al best de­fense against for­eign in­vaders and have proven the best treat­ments for oth­er pathogens, in­clud­ing an­thrax, RSV, and Ebo­la. Two of the most watched ef­forts are the ones from Re­gen­eron and Vir Biotech­nol­o­gy, both of which are set to en­ter the clin­ic in the com­ing weeks and months.

Most re­cent­ly Ab­b­Vie stepped in­to the race, sign­ing a col­lab­o­ra­tion with the Chi­nese biotech Har­bour Med and a pair of Dutch aca­d­e­m­ic and med­ical cen­ters. An­ti­bod­ies are par­tic­u­lar­ly dif­fi­cult to man­u­fac­ture, and, like vac­cines, mul­ti­ple can­di­dates may be need­ed. Jun­shi said they can make 100,000 dos­es by the end of the year.

Sec­ond hyr­doxy­chloro­quine RCT fails, this time in hos­pi­tal­ized pa­tients

Days af­ter a large Uni­ver­si­ty of Min­neso­ta study found the an­ti-malar­i­al hy­drox­y­chloro­quine didn’t pre­vent ex­posed pa­tients from de­vel­op­ing Covid-19, UK sci­en­tists have halt­ed a tri­al af­ter find­ing that the drug had no ef­fect on hos­pi­tal­ized pa­tients.

”This is not a treat­ment for Covid-19. It doesn’t work,” lead in­ves­ti­ga­tor and Ox­ford Uni­ver­si­ty pro­fes­sor Mar­tin Lan­dray told re­porters, per Reuters. “This re­sult should change med­ical prac­tice world­wide. We can now stop us­ing a drug that is worth­less.”

The re­sults add to a grow­ing, if some­times mud­dled body of ev­i­dence against a drug that doc­tors iden­ti­fied ear­ly as one of the po­ten­tial off-the-shelf treat­ments for the virus and which be­came one of the most talked-about and stud­ied ther­a­pies af­ter Pres­i­dent Trump tout­ed it in press con­fer­ences, of­ten over the ad­vice of med­ical ex­perts.

While re­searchers raced to test the drug in ran­dom­ized, con­trolled tri­als, doc­tors — boost­ed by an FDA emer­gency use au­tho­riza­tion for the pill and lack­ing oth­er good op­tions — pre­scribed it for their Covid-19 pa­tients. Two of the ear­li­est pieces of ev­i­dence against its use as a coro­n­avirus treat­ment then were pub­li­ca­tions in the New Eng­land Jour­nal of Med­i­cine and the Lancet that tracked med­ical records of pa­tients world­wide who had been giv­en the drug and found hy­drox­y­chloro­quine ac­tu­al­ly raised the risk of death.

Both of those tri­als were, in a no­table and high­ly un­usu­al event for the pres­ti­gious jour­nals, re­tract­ed last week af­ter in­ves­ti­ga­tors found they were un­able to ver­i­fy the da­ta, which had been col­lect­ed by a tiny US firm with ques­tion­able sci­en­tif­ic ex­per­tise. Those stud­ies had in­formed de­ci­sions by WHO and sev­er­al re­search in­sti­tutes to halt tri­als on the drug, and their re­trac­tion in the­o­ry opened the door for the drug to still prove ef­fec­tive.

But the re­trac­tions came just as the first and much-an­tic­i­pat­ed ran­dom­ized con­trolled tri­als — the gold stan­dard when it comes to eval­u­at­ing drugs — came out. First, in NE­JM, the Uni­ver­si­ty of Min­neso­ta found that across 821 pa­tients, hy­drox­y­chloro­quine didn’t work as post-ex­po­sure pro­phy­lax­is.

Now, the UK tri­al found it didn’t work in hos­pi­tal­ized pa­tients. In­ves­ti­ga­tors as­signed 1,542 pa­tients to hy­drox­y­chloro­quine and com­pared them with 3,132 pa­tients ran­dom­ly as­signed to stan­dard of care. There was no sig­nif­i­cant dif­fer­ence in death rates af­ter 28 days, length of stay in the hos­pi­tal or oth­er out­comes.

Tri­als are for now con­tin­u­ing around the world for the an­ti-malar­i­al and some doc­tors con­tin­ue to see po­ten­tial ben­e­fit, but the in­ves­ti­ga­tors in both of the ran­dom­ized con­trolled stud­ies were blunt in their as­sess­ments.

“Now that we know there is no ben­e­fit and we know there are side ef­fects, there is re­al­ly no rea­son to take this drug fur­ther,” the Uni­ver­si­ty of Min­neso­ta’s Rad­ha Ra­jas­ing­ham told End­points News last week.

Lan­dray, the Ox­ford pro­fes­sor, said sim­ply: “If you’re ad­mit­ted to hos­pi­tal, don’t take hy­drox­y­chloro­quine.”

A UK vac­cine lab tries to get around the in­dus­try

All roads to a Covid-19 vac­cine so far have led through Big Phar­ma. Now a promi­nent British lab is try­ing to change that.

Robin Shat­tock, the sci­en­tist be­hind the vac­cine project at the Im­pe­r­i­al Col­lege of Lon­don, told the New York Times to­day that the col­lege is start­ing a new “so­cial en­ter­prise” that would en­sure Shat­tock’s vac­cine is avail­able at the low­est pos­si­ble cost both in the UK and in low- and mid­dle-in­come coun­tries. The Im­pe­r­i­al Col­lege’s work is one of two aca­d­e­m­ic Covid-19 vac­cine projects the UK gov­ern­ment has poured tens of mil­lions of pounds in­to, along­side the much-pub­li­cized Ox­ford Uni­ver­si­ty can­di­date.

The new com­pa­ny will be called VacE­quity Glob­al Health and found­ed in part­ner­ship with the Hong-Kong based in­vest­ment firm Morn­ing­side Ven­tures. While aim­ing to make the vac­cine wide­ly ac­ces­si­ble, VacE­quity will al­so be for-prof­it and may charge high­er rates in wealth­i­er coun­tries.

The new ven­ture comes amid a grow­ing de­bate over how to best to scale up and al­lo­cate a Covid-19 vac­cine once one (or sev­er­al) proved ef­fec­tive, par­tic­u­lar­ly for mid­dle-in­come coun­tries. With the US and the UK fund­ing can­di­dates ear­ly and lav­ish­ly in ex­change for pref­er­en­tial ac­cess, the EU has re­cent­ly sig­naled they would make sim­i­lar in­vest­ments, and GAVI — the Gates-backed non­prof­it that works on vac­ci­na­tion across the de­vel­op­ing world — is try­ing to do the same.

Al­most all of these ef­forts, though, go through ex­ist­ing big biotech and phar­ma com­pa­nies. Ox­ford part­nered with As­traZeneca on their vac­cine, and have since signed agree­ments with the US, the UK and en­ti­ties in oth­er coun­tries promis­ing to sup­ply up to 2 bil­lion dos­es of a vac­cine on a “no prof­it” ba­sis. Mod­er­na, de­vel­op­ing a vac­cine de­signed in part at the NIH, signed a deal with the Swiss CMO Lon­za to scale up to 1 bil­lion dos­es by next year.

The col­lege thinks they may have an up­per hand on scale be­cause of the tech­nol­o­gy they use, called self-am­pli­fy­ing RNA. It is sim­i­lar to the tech­nol­o­gy used in the vac­cines be­ing de­vel­oped by Mod­er­na and the Pfiz­er-BioN­Tech col­lab­o­ra­tion — de­liv­er­ing the ge­net­ic code for the virus anti­gen — but it can be giv­en in much small­er dos­es be­cause the RNA makes copies of it­self af­ter it’s been in­ject­ed. An­oth­er RNA vac­cine ef­fort from Cure­Vac is al­so de­signed to be giv­en at much small­er dos­es, al­though that one works by trig­ger­ing an im­me­di­ate im­mune re­sponse.

Shat­tock’s vac­cine is set to en­ter a Phase I/II on June 15,  fol­lowed by a 6,000-per­son ef­fi­ca­cy tri­al in Oc­to­ber.

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

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.

Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; 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.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.