Yet more doses of the AstraZeneca-Oxford vaccine; A second randomized hydroxychloroquine study fails – Endpoints News

Jason Mast

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.



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About the Author: Jason Mast

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