Covid-19 roundup: Emer­gen­t's er­ror costs J&J a vac­cine batch; Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

J&J has run in­to a snag in pro­duc­tion of its Covid-19 vac­cine af­ter its qual­i­ty pa­trol spot­ted prob­lems with one batch of drug sub­stance.

The is­sue — which the New York Times re­port­ed was due to a mix-up be­tween the vec­tors used in J&J and As­traZeneca’s vac­cines — sent J&J in­to trou­ble-shoot­ing mode. The com­pa­ny said it’s send­ing ad­di­tion­al ex­perts in man­u­fac­tur­ing, tech­ni­cal op­er­a­tions and qual­i­ty to su­per­vise on­site at Emer­gent’s Bayview fa­cil­i­ty, which was once tout­ed for its ca­pac­i­ty to rapid­ly scale man­u­fac­tur­ing.

In a state­ment, J&J didn’t con­firm whether the batch would in­deed trans­late to 15 mil­lion dos­es, as the Times re­port­ed. It in­stead em­pha­sized that the Emer­gent site has not yet been au­tho­rized by the FDA to make the ac­tive in­gre­di­ents of its one-shot, ade­n­ovirus vec­tor-based vac­cine, and that it’s on track to de­liv­er a to­tal of 1 bil­lion dos­es by 2021.

But while a board mem­ber has pre­vi­ous­ly pre­dict­ed they would de­liv­er a to­tal of 100 mil­lion dos­es to the US by April, J&J is now push­ing that goal to the end of May. Through April, they ex­pect to have 24 mil­lion dos­es, on top of the 20 mil­lion al­ready in arms.

“This batch was nev­er ad­vanced to the fill­ing and fin­ish­ing stages of our man­u­fac­tur­ing process,” the com­pa­ny added. “This is an ex­am­ple of the rig­or­ous qual­i­ty con­trol ap­plied to each batch of drug sub­stance.”

Emer­gent, which had inked a $480 mil­lion deal to sup­ply J&J’s Covid vac­cine for the next two years, had been known as the mak­er of an an­thrax vac­cine pri­or to the pan­dem­ic.

Billed as a cen­ter for in­no­va­tion in ad­vanced de­vel­op­ment and man­u­fac­tur­ing (CIADM), the Bayview site was built as part of a part­ner­ship with BAR­DA to speed de­vel­op­ment and pro­duc­tion of vac­cines or treat­ments for pan­dem­ic re­sponse.

Pfiz­er head says EU re­stric­tions slow vac­cine dis­tri­b­u­tion process

The Eu­ro­pean Union has seen a short­age in Covid-19 vac­cine avail­abil­i­ty, and Pfiz­er head Dan­ny Hen­drikse wants it to be known that new EU re­stric­tions won’t make end­ing that short­age any eas­i­er.

The VP of glob­al sup­ply spoke out against new EU rules about the free move­ment of goods across bor­ders, say­ing that it made it more dif­fi­cult for the com­pa­ny to ex­port the vac­cine.

“Ul­ti­mate­ly what we would like our col­leagues to do is to fo­cus on mak­ing and dis­trib­ut­ing the vac­cine,” he told the UK’s Tele­graph. “The com­po­nents don’t just come from Eu­rope, but from all over the world.”

Pfiz­er told EU lead­ers that the amount of time it takes to make the vac­cine has been cut in half from 110 days to 60, thanks to an in­crease of pro­duc­tion at its Bel­gium plant. But that batch is start­ed in the US, with DNA plas­mids.

The news comes on the back of Ger­many’s sus­pen­sion of the As­traZeneca vac­cine for pa­tients un­der the age of 40 due to a rare, but fa­tal, blood clot called ve­nous throm­bo­sis. The clot was par­tic­u­lar­ly present in young women, a re­port said. EU’s med­ical reg­u­la­tor said that there was no ev­i­dence to sup­port the de­ci­sion to stop us­ing the vac­cine, how­ev­er.

Pfiz­er and BioN­Tech con­firm high ef­fi­ca­cy, no se­ri­ous safe­ty con­cerns af­ter sec­ond Covid-19 vac­cine dose

Six months af­ter Pfiz­er and BioN­Tech’s Phase III clin­i­cal tri­al par­tic­i­pants re­ceived the sec­ond dose of their Covid-19 vac­cine, the com­pa­nies have an­nounced that there are no se­ri­ous safe­ty con­cerns.

Of the 927 con­firmed symp­to­matic cas­es, 850 of the cas­es were in the place­bo group and 77 were in the group giv­en BNT162b2, good for a vac­cine ef­fi­ca­cy of 91.3%, ac­cord­ing to a re­lease. Six-month re­sults al­so showed 100% ef­fi­ca­cy in pre­vent­ing se­vere dis­ease.

Vac­cine safe­ty has now been eval­u­at­ed in 44,000 par­tic­i­pants ages 16 and up. Sci­en­tists have deemed the vac­cine 100% ef­fec­tive in South Africa, where the B.1.351 vari­a­tion is preva­lent.

“The high vac­cine ef­fi­ca­cy ob­served through up to six months fol­low­ing a sec­ond dose and against the vari­ant preva­lent in South Africa pro­vides fur­ther con­fi­dence in our vac­cine’s over­all ef­fec­tive­ness,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

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.

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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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.

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.

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.

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.

Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.