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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Rafaèle Tordjman (Jeito Capital)

Con­ti­nu­ity and di­ver­si­ty: Rafaèle Tord­j­man's women-led VC firm tops out first fund at $630M

For a first-time fund, Jeito Capital talks a lot about continuity.

Rafaèle Tordjman had spotlighted that concept ever since she started building the firm in 2018, promising to go the extra mile(s) with biotech entrepreneurs while pushing them to reach patients faster.

Coincidentally, the lack of continuity was one of the sore spots listed in a report about the European healthcare sector published that same year by the European Investment Bank — whose fund is one of the LPs, alongside the American pension fund Teacher Retirement System of Texas and Singapore’s Temasek, to help Jeito close its first fund at $630 million (€534 million). As previously reported, Sanofi had chimed in €50 million, marking its first investment in a French life sciences fund.