Covid-19 roundup: No­vavax de­lays US, Mex­i­co vac­cine tri­al (again); In­dia in­ves­ti­gates re­port­ed side ef­fects in As­traZeneca study

No­vavax is de­lay­ing the start of its US/Mex­i­co Phase III tri­al a sec­ond time, even as it com­pletes en­roll­ment for two oth­er stud­ies of its Covid-19 vac­cine.

Hav­ing pre­vi­ous­ly pushed the tri­al launch from Oc­to­ber to the end of No­vem­ber, No­vavax now says the piv­otal tri­al that will sup­port reg­u­la­to­ry clear­ance in the US and be­yond will be­gin “in the com­ing weeks.” Man­u­fac­tur­ing is­sues, which were to blame for the last de­lay, ap­pear to be in play in this lat­est holdup as well.

From a re­lease:

No­vavax will use vac­cine ma­te­r­i­al pro­duced at com­mer­cial scale for this tri­al. There­fore, the Com­pa­ny has been work­ing close­ly with the FDA to com­plete tri­al-ini­ti­a­tion gat­ing ac­tiv­i­ties re­lat­ed to its com­mer­cial-scale pro­duc­tion at FU­JI­FILM Diosynth Biotech­nolo­gies in Re­search Tri­an­gle Park, North Car­oli­na.

Vol­un­teers will be re­cruit­ed and dosed across more than 100 tri­al sites, it added.

Mean­while, the piv­otal Phase III tri­al in the UK now has 15,000 par­tic­i­pants who will re­ceive with NVX-CoV2373 or place­bo, while the Phase IIb study in South Africa has al­so ful­ly en­rolled 4,422 vol­un­teers, in­clud­ing 245 who are HIV-pos­i­tive and med­ical­ly sta­ble. De­signed to in­crease racial, age and ge­o­graph­ic di­ver­si­ty in the da­ta, the tri­al is par­tial­ly fund­ed by the Bill & Melin­da Gates Foun­da­tion.

For both tri­als, No­vavax said, in­ter­im da­ta are ex­pect­ed as ear­ly as the first quar­ter of 2021.

Based in Mary­land, No­vavax has one of the six vac­cines that Op­er­a­tion Warp Speed has pub­licly backed, hav­ing nabbed $1.6 bil­lion to fund the piv­otal tri­al in the US and Mex­i­co as well as scale-up man­u­fac­tur­ing. — Am­ber Tong

In­di­an vol­un­teer in As­traZeneca vac­cine tri­al al­leges ‘neu­ro­log­i­cal’ symp­toms 

A new al­leged ad­verse re­ac­tion has cropped up in As­traZeneca and Ox­ford’s glob­al Covid-19 vac­cine de­vel­op­ment pro­gram — al­though an in­sti­tu­tion as­sist­ing in­to an in­quiry said: “there was no im­me­di­ate cause of con­cern.”

The In­di­an Coun­cil of Med­ical Re­search re­ceived a com­plaint from a vol­un­teer along­side the Drugs Con­troller Gen­er­al of In­dia, As­traZeneca and the Serum In­sti­tute of In­dia, which is run­ning the Phase III tri­al in the coun­try. The un­named 40-year-old man said he had suf­fered se­ri­ous “neu­ro­log­i­cal and psy­cho­log­i­cal” symp­toms af­ter re­ceiv­ing the vac­cine, Reuters re­port­ed. He’s seek­ing 50 mil­lion ru­pees ($676,288) in dam­ages and call­ing for test­ing, man­u­fac­tur­ing and dis­tri­b­u­tion to be sus­pend­ed.

Pre­vi­ous re­ports of neu­ro­log­i­cal ill­ness­es have raised con­cerns about the safe­ty of the ade­n­ovirus-based vac­cine can­di­date, so much so that As­traZeneca had to halt dos­ing — briefly in the UK and for six weeks in the US, drag­ging it be­hind the oth­er fron­trun­ners.

ICMR, how­ev­er, has so far found no rea­son to rec­om­mend stop­ping the study in In­dia.

“There was no im­me­di­ate cause of con­cern at this stage,” Sami­ran Pan­da, head of Epi­demi­ol­o­gy and Com­mu­ni­ca­ble Dis­eases at the ICMR, told Reuters. He added: “It doesn’t mean that long term as­sess­ment will not hap­pen, it is still hap­pen­ing. I am aware of the ac­tiv­i­ty.”

In an in­ter­im read­out of two tri­als con­duct­ed in the UK and Brazil, As­traZeneca wrote that “no se­ri­ous safe­ty events re­lat­ed to the vac­cine have been con­firmed.” Fur­ther de­tails like­ly won’t be dis­closed un­til the da­ta are pub­lished in a peer-re­viewed jour­nal.

Am­ber Tong

As­traZeneca tar­get­ed by North Ko­re­an hack­ers — re­port

Sus­pect­ed North Ko­re­an hack­ers re­cent­ly took a shot at one of the fron­trun­ners in the race for a Covid-19 vac­cine, un­named sources told Reuters

The hack­ers al­leged­ly tried to break in­to As­traZeneca’s sys­tems by pos­ing as job re­cruiters and send­ing doc­u­ments with ma­li­cious code to staff mem­bers via LinkedIn and What­sApp, Reuters re­port­ed. Anony­mous sources said the tech­niques were part of a hack­ing cam­paign for which US of­fi­cials have deemed North Ko­rea re­spon­si­ble.

As­traZeneca isn’t the first biotech to be tar­get­ed by hack­ers this year. Hack­ers from Iran, Chi­na and Rus­sia have set their sights on drug mak­ers and the WHO, al­though they’ve de­nied the ac­cu­sa­tions, ac­cord­ing to Reuters. Back in Ju­ly, a US se­cu­ri­ty of­fi­cial said hack­ers linked to the Chi­nese gov­ern­ment at­tempt­ed to swipe da­ta from Mod­er­na.

The news comes as As­traZeneca an­nounced it’s con­duct­ing a new study for its coro­n­avirus vac­cine, which is trail­ing can­di­dates from Pfiz­er and Mod­er­na. As­traZeneca an­nounced last week its can­di­date de­vel­oped with Ox­ford Uni­ver­si­ty was 90% ef­fec­tive, but on­ly for a dos­ing reg­i­men giv­en to a small group of par­tic­i­pants due to an er­ror. In a larg­er co­hort of par­tic­i­pants giv­en the in­tend­ed reg­i­men, the vac­cine was about 62% ef­fec­tive.

Mod­er­na and Pfiz­er, on the oth­er hand, have said their vac­cines are 94.1% and 95% ef­fec­tive, re­spec­tive­ly. Pfiz­er has al­ready sub­mit­ted its EUA ap­pli­ca­tion, and Mod­er­na said it’s about to do the same.

CEO Pas­cal So­ri­ot told Bloomberg the new in­ter­na­tion­al study could be faster, “be­cause we know the ef­fi­ca­cy is high so we need a small­er num­ber of pa­tients.” — Nicole De­Feud­is

EIB bets a drug that flopped in can­cer, ALS can help fight Covid-19

Af­ter spend­ing years de­vel­op­ing the ty­ro­sine ki­nase in­hibitor ma­sitinib for can­cer and amy­otroph­ic lat­er­al scle­ro­sis, AB Sci­ence has now se­cured a €15 mil­lion ($17.98 mil­lion) loan from the Eu­ro­pean In­vest­ment Bank to test it for Covid-19.

Alain Moussy, co-founder and chief ex­ec­u­tive of AB Sci­ence, tout­ed the fi­nanc­ing deal as val­i­da­tion of the drug’s “dual an­tivi­ral and an­ti-in­flam­ma­to­ry mech­a­nism.”

It’s a big deal for the 16-year-old biotech, which has strug­gled with cred­i­bil­i­ty is­sues as cheery press re­leas­es were fol­lowed by EMA re­jec­tions and reg­u­la­to­ry halts.

In to­tal, the EIB has shelled out €600 mil­lion to 19 dif­fer­ent biotechs and medtechs with dif­fer­ent pro­pos­als to fight the virus. Most no­tably, it’s pro­vid­ed €100 mil­lion in debt fi­nanc­ing to BioN­Tech months be­fore it Pfiz­er-part­nered mR­NA vac­cine was shown to be 95% ef­fec­tive in a Phase III tri­al. — Am­ber Tong

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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