Covid-19 roundup: Blood clot risk much high­er from dis­ease than vac­cines — study; Brazil OKs In­ovio PhI­II tri­al

Re­searchers in the UK have pub­lished a new pa­per show­ing that the risk of blood clots is much high­er af­ter a Covid-19 in­fec­tion than fol­low­ing vac­ci­na­tion.

In one of the largest stud­ies of its kind, the sci­en­tists looked at da­ta from more than 29 mil­lion in­di­vid­u­als in the UK com­par­ing the Pfiz­er/BioN­Tech and As­traZeneca vac­cines to Covid-19 cas­es. They found that for every 10 mil­lion peo­ple who re­ceive their first As­traZeneca shot, there were 107 more cas­es of low platelet counts than one would nor­mal­ly ex­pect, an­oth­er 66 de­vel­oped blood clots and sev­en had CVST, or blood clot­ting in the brain. And for those who re­ceived the Pfiz­er/BioN­Tech shot, there were an ex­tra 143 cas­es of is­chemic stroke.

Each fig­ure rose sharply when look­ing at Covid-19 pa­tients, the analy­sis found. There were an es­ti­mat­ed 934 “ex­cess” cas­es of low platelets, 12,614 in­ci­dents of blood clots, 1699 of is­chemic stroke and 20 of CVST.

“This is cru­cial not on­ly for the present and fu­ture safe­ty of Covid-19 vac­cines, but al­so will hope­ful­ly pave the way more broad­ly for fu­ture in­ter­na­tion­al har­mon­i­sa­tion and col­lab­o­ra­tion in drug safe­ty mon­i­tor­ing,” re­searchers wrote in a linked ed­i­to­r­i­al, dis­cussing the ef­fort to fur­ther un­der­stand vac­cines’ ben­e­fit-risk pro­file.

The da­ta come from a near­ly five-month pe­ri­od start­ing at the be­gin­ning of De­cem­ber 2020 through April 24, 2021. Re­searchers tracked 19.6 mil­lion peo­ple who got the As­traZeneca shot, 9.6 mil­lion who re­ceived Pfiz­er/BioN­Tech and 1.8 mil­lion Covid-19 pa­tients.

As­traZeneca’s vac­cine in par­tic­u­lar had been dogged by safe­ty con­cerns dur­ing its large-scale Phase III tri­al in 2020 and in­to 2021. Re­ports of blood clot­ting events first emerged ear­li­er this year and the shot has yet to be au­tho­rized or ap­proved by the FDA. The Pfiz­er/BioN­Tech vac­cine was tagged with a safe­ty warn­ing in June as well, though this stemmed from a risk of heart in­flam­ma­tion.

But the UK re­searchers are out­lin­ing — build­ing on more and more ev­i­dence — that con­tract­ing Covid-19 is far more dan­ger­ous than get­ting vac­ci­nat­ed. In­di­vid­u­als are nine times more like­ly to suf­fer from low platelet counts and 191 times more like­ly to de­vel­op blood clots, per the in­ci­dence rate num­bers.

In­ovio re­ceives OK from Brazil to start Phase III study

In­ovio ran in­to a sig­nif­i­cant set­back in 2020 when its Covid-19 vac­cine ran in­to an FDA hold, and then an­oth­er ear­li­er this year try­ing to se­cure fund­ing for its Phase III Covid-19 vac­cine tri­al. But the biotech is one step clos­er to get­ting it off the ground.

The com­pa­ny an­nounced Thurs­day that it has re­ceived the go-ahead from Brazil’s health reg­u­la­tor to start the Phase III seg­ment of its Phase II/III study. Pend­ing fur­ther clear­ance, In­ovio plans to run the tri­al in sev­er­al coun­tries in Latin Amer­i­ca, Asia and the African con­ti­nent.

“With many coun­tries in the world ex­pe­ri­enc­ing low vac­ci­na­tion rates and see­ing an in­crease in in­fec­tions, we feel the ur­gency to ad­vance INO-4800 glob­al­ly,” CEO Joseph Kim said in a state­ment.

Thurs­day’s green light comes a few weeks af­ter In­ovio got ap­proval to test its DNA vac­cine as a boost­er in Chi­na with Chi­nese biotech Sino­vac.

In­ovio pre­vi­ous­ly had fund­ing from the De­part­ment of De­fense to test its vac­cine can­di­date, but the Pen­ta­gon scrapped fund­ing for the Phase III seg­ment of its study back in April. At the time, In­ovio said the move was due to the grow­ing avail­abil­i­ty of oth­er Covid-19 vac­cines and that it was not, it as­sert­ed, re­lat­ed to the par­tial clin­i­cal hold in place since Sep­tem­ber 2020.

And in a 10-K fil­ing at the time, In­ovio was un­sure whether it would ever be able to get its Phase III launched, writ­ing, “We do not know whether our planned Phase 3 clin­i­cal tri­al will be­gin on time or be com­plet­ed on sched­ule, if at all.”

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

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er ex­pands in­to France; Omi­cron-spe­cif­ic ver­sion of Mod­er­na's boost­er com­ing soon 

As the hype surrounding Pfizer’s antiviral Covid-19 pill swirls, the pharma announced that it will build a production facility in France to make the drug as a part of a five-year investment.

Pfizer will team up with Novasep to install equipment and initiate tech transfer and on-site development at Novasep’s Mourenx facility. The move is a part of a $594 million investment in France.

“We are of course proud to contribute to the manufacturing of this medicine which has shown in clinical trials to have a positive impact on hospitalization among at-risk Covid-19 patients,” Novasep’s CEO Michel Spagnol said in a statement. “This contract also validates our investment strategy for several years and our focus on small molecules.”