Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

Covid-19 roundup: Cure­Vac push­es ahead for vac­cine au­tho­riza­tion de­spite fail­ing to hit 50% ef­fi­ca­cy thresh­old

All mR­NA vac­cines are not cre­at­ed equal. And Ger­many-based Cure­Vac found out the hard way on Wednes­day as its piv­otal tri­al showed its vac­cine is 48% ef­fec­tive against Covid-19 across all age groups stud­ied.

While reg­u­la­tors have set the ef­fi­ca­cy bar at 50% for new Covid-19 vac­cines, Cure­Vac CEO Franz-Wern­er Haas made clear on Wednes­day that he still in­tends to still seek li­cen­sure for the vac­cine, par­tic­u­lar­ly in the EU and for cer­tain age groups that per­formed bet­ter in the tri­al than the over­all re­sult.

“In this fi­nal analy­sis, CVn­CoV demon­strates a strong pub­lic health val­ue in ful­ly pro­tect­ing study par­tic­i­pants in the age group of 18 to 60 against hos­pi­tal­iza­tion or death and 77% against mod­er­ate and se­vere dis­ease – an ef­fi­ca­cy pro­file, which we be­lieve will be an im­por­tant con­tri­bu­tion to help man­age the COVID-19 pan­dem­ic and the dy­nam­ic vari­ant spread,” he said in a state­ment.

Haas al­so told the Wash­ing­ton Post in an in­ter­view that Cure­Vac is in dis­cus­sion with the Eu­ro­pean Med­i­cines Agency about the da­ta, with an em­pha­sis on that 18 to 60 year old group. The Eu­ro­pean Com­mis­sion last No­vem­ber or­dered 225 mil­lion dos­es of the vac­cine, with an op­tion to buy 180 mil­lion more.

But a mem­ber of the Ger­man par­lia­ment tweet­ed on ear­ly Thurs­day that he did not think the vac­cine would be au­tho­rized, even for the lim­it­ed pop­u­la­tion, al­though he still thinks the Ger­man gov­ern­ment was right to in­vest in Cure­Vac.

Break­down of tri­al re­sults: Of the 228 cas­es of Covid-19 that oc­curred dur­ing the Phase IIb/III tri­al in about 40,000 healthy par­tic­i­pants, 83 were among those re­ceiv­ing the ex­per­i­men­tal vac­cine, while 145 cas­es were among those ad­min­is­tered place­bo.

And while the vac­cine proved to be 100% pro­tec­tive (0 cas­es among those re­ceiv­ing the vac­cine vs. 6 on place­bo) against hos­pi­tal­iza­tions or death, Cure­Vac al­so said that in par­tic­i­pants above 60 years, “the avail­able da­ta did not en­able a sta­tis­ti­cal­ly sig­nif­i­cant de­ter­mi­na­tion of ef­fi­ca­cy.”

What’s next: As Cure­Vac awaits word from the EMA, the com­pa­ny is al­so work­ing on sec­ond-gen­er­a­tion Covid vac­cine can­di­dates in part­ner­ship with GSK, and ex­pects that the first can­di­date will reach clin­i­cal test­ing in the third quar­ter of 2021, with the goal of mar­ket­ing the vac­cine next year.

Dis­agree­ments among WTO mem­bers per­sist on waiv­er to roll back IP pro­tec­tions for Covid vac­cines

As the Eu­ro­pean Union hard­ens its op­po­si­tion to tem­porar­i­ly waiv­ing IP pro­tec­tions, splits among the fac­tions sup­port­ing such a waiv­er are be­gin­ning to show, ac­cord­ing to Law360 cov­er­age of an in­for­mal meet­ing con­vened in Gene­va by Am­bas­sador Dagfinn Sør­li of Nor­way.

While any waiv­er will re­quire the unan­i­mous agree­ment of the WTO’s 159 mem­bers (and more than 100 mem­bers sup­port such an IP waiv­er), dis­cus­sions among those in fa­vor of the waiv­er are splin­ter­ing over whether to in­clude more than just vac­cines. The Biden ad­min­is­tra­tion has pledged its sup­port for just a vac­cine waiv­er, seek­ing a more prag­mat­ic ap­proach, while the South Africa del­e­ga­tion is seek­ing to ex­tend the waiv­er to “pri­or­i­ty med­ical de­vices,” such as ven­ti­la­tors, pa­tient mon­i­tors and med­ical and sur­gi­cal masks, as well as the raw ma­te­ri­als need­ed to make the vac­cines.

The EU main­tains that its al­ter­na­tive plan, which wouldn’t ac­tu­al­ly waive any IP, could do more to build up vac­cine sup­plies. And in the in­for­mal ne­go­ti­a­tions on Wednes­day, the US joined with the EU — along with the UK, Switzer­land, Mex­i­co, Japan and Brazil, among oth­ers — in ar­gu­ing that greater ac­cess to Covid vac­cines and ther­a­peu­tics would still be pos­si­ble while large­ly main­tain­ing IP laws as they are.

EU launch­es dig­i­tal cer­tifi­cate to ease trav­el for those who’ve been vac­ci­nat­ed

The Eu­ro­pean Com­mis­sion on Thurs­day of­fi­cial­ly launched its “EU Dig­i­tal COVID Cer­tifi­cate Reg­u­la­tion,” to ease the process of trav­el­ing be­tween EU coun­tries for those who are vac­ci­nat­ed.

Un­der the new rules, EU mem­ber states are not al­lowed to im­pose ad­di­tion­al trav­el re­stric­tions on hold­ers of a cer­tifi­cate, un­less they are nec­es­sary and pro­por­tion­ate to safe­guard pub­lic health.

“In March, we promised to have an EU-wide sys­tem to fa­cil­i­tate free and safe trav­el with­in the EU by the sum­mer hol­i­days. Now we can con­firm that the EU Dig­i­tal COVID Cer­tifi­cate sys­tem is up and run­ning,” said EC pres­i­dent Ur­su­la von der Leyen. “A vast ma­jor­i­ty of EU Mem­ber States are al­ready con­nect­ed to the sys­tem and ready to is­sue and ver­i­fy the Cer­tifi­cates. More than 200 mil­lion cer­tifi­cates have al­ready been gen­er­at­ed.”

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.