Covid-19 roundup: Biden now plans boost­ers af­ter 6 months as Pfiz­er sub­mits sBLA; 1.6M Mod­er­na dos­es con­t­a­m­i­nat­ed in Japan — re­ports

Re­ports sur­faced ear­li­er this month that Pres­i­dent Joe Biden’s ad­min­is­tra­tion was prepar­ing to an­nounce a boost­er shot plan call­ing for third dos­es to be ad­min­is­tered eight months af­ter an in­di­vid­ual’s sec­ond shot. Those plans, how­ev­er, have re­port­ed­ly changed.

The new plan from fed­er­al reg­u­la­tors will now call for a boost­er shot six months fol­low­ing the sec­ond mR­NA dose, the Wall Street Jour­nal re­port­ed Wednes­day, giv­en that da­ta from vac­cine mak­ers and oth­er coun­tries are based on six-month fol­low-ups. An un­named of­fi­cial told WSJ that ap­proval for all three OK’ed shots will like­ly come in mid-Sep­tem­ber.

Wednes­day’s re­port came as Pfiz­er and BioN­Tech sub­mit­ted a sup­ple­men­tal BLA for boost­er shots ear­li­er in the day, hand­ing da­ta to the FDA from a 306-per­son Phase III study. In the tri­al, par­tic­i­pants were giv­en a third vac­cine dose be­tween 4.8 and 8 months af­ter their sec­ond shot, with Pfiz­er say­ing the boost­er elicit­ed “ro­bust” an­ti­bod­ies to the orig­i­nal strain at least one month af­ter the third shot in those with­out a con­firmed Covid-19 case.

Ad­di­tion­al­ly, 50% neu­tral­iz­ing titers were more than 3.3 times high­er one month af­ter the third dose com­pared to the same time pe­ri­od fol­low­ing the sec­ond shot, Pfiz­er said. Da­ta are ex­pect­ed to be sub­mit­ted to a peer-re­viewed jour­nal in the com­ing weeks.

Af­ter re­ceiv­ing full ap­proval for the two-dose reg­i­men on Mon­day, Pfiz­er is rolling right along with its boost­er plans, and is ahead of the pack in this re­gard. Mod­er­na on­ly sub­mit­ted its BLA for its vac­cine ear­li­er this week, while J&J hasn’t yet sought ap­proval for its one-dose vac­cine.

The new boost­er plan and sBLA come a week af­ter fed­er­al of­fi­cials rec­om­mend­ed a boost­er shot for adults who had re­ceived a two-dose mR­NA vac­cine be­gin­ning in Sep­tem­ber. J&J, sport­ing an ade­n­ovirus ap­proach, al­so gave a first look at its own boost­er da­ta Wednes­day, say­ing the ex­tra shot prompt­ed a nine-fold an­ti­body in­crease 28 days af­ter the first shot.

Some ex­perts crit­i­cized the da­ta, how­ev­er, as it on­ly came from an analy­sis of 20 pa­tients. Scripps Re­search Foun­da­tion founder Er­ic Topol called for a deep­er look in­to the da­ta on Twit­ter, ask­ing to see re­sults from J&J’s two-dose vac­cine tri­al.

Mod­er­na, Take­da forced to with­draw 1.6M dos­es af­ter con­t­a­m­i­na­tion re­ports

The Japan­ese gov­ern­ment has tak­en about 1.6 mil­lion dos­es of Mod­er­na’s Covid-19 vac­cine out of use af­ter re­ports of con­t­a­m­i­na­tion arose around the coun­try, Nikkei Asia re­port­ed Wednes­day.

Vac­ci­na­tion cen­ters in Japan be­gan notic­ing for­eign ma­te­ri­als in vials that re­act­ed to mag­nets, dri­ving spec­u­la­tion the con­t­a­m­i­nants could have been met­al, per a gov­ern­ment of­fi­cial. Ac­cord­ing to a sep­a­rate Reuters re­port, the first con­t­a­m­i­na­tion re­ports be­gan com­ing in on Au­gust 16 when Take­da, which dis­trib­utes the Mod­er­na vac­cine in Japan, be­came aware.

Take­da wait­ed un­til Wednes­day to alert the gov­ern­ment be­cause it need­ed time to fig­ure out which vials had been botched and where they had been dis­trib­uted, of­fi­cials told Reuters.

The Japan­ese de­fense min­istry al­so said shots from the con­t­a­m­i­nat­ed batch had been used at a mass vac­ci­na­tion site in Os­a­ka be­tween Au­gust 6 and Au­gust 20, but did not dis­close to Reuters how many peo­ple had been af­fect­ed. So far, there have been no re­port­ed health is­sues re­lat­ed to the con­t­a­m­i­nat­ed shots, and oth­er batch­es of the Mod­er­na shot have not been paused.

Mod­er­na and Japan both said there were no safe­ty or ef­fi­ca­cy is­sues re­lat­ed to the re­ports, and that tak­ing the vials out of cir­cu­la­tion is a pre­cau­tion­ary mea­sure. Two lots ad­ja­cent to the con­t­a­m­i­nat­ed batch have al­so been put on hold. It is be­lieved a man­u­fac­tur­ing is­sue at a plant in Spain caused the con­t­a­m­i­na­tion, Mod­er­na told the out­lets.

The Cam­bridge, MA-based biotech re­ceived emer­gency au­tho­riza­tion in Japan in May. Japan has been bat­tling its worst surge of the pan­dem­ic due to the high­ly con­ta­gious Delta vari­ant, top­ping 25,000 cas­es per day this month. Cur­rent­ly, 54% of Japan’s pop­u­la­tion has re­ceived one dose and 43% have been ful­ly vac­ci­nat­ed. Prime min­is­ter Yoshi­hide Suga is aim­ing to have about 60% of the coun­try’s pop­u­la­tion ful­ly vac­ci­nat­ed by the end of Sep­tem­ber.

Biden urged to re­ject Brazil bill scrap­ping IP pro­tec­tions

Af­ter sup­port­ing a World Trade Or­ga­ni­za­tion pro­pos­al to waive vac­cine IP ear­li­er this year, the Biden ad­min­is­tra­tion is be­ing urged to speak out against a new bill pro­posed by Brazil that would al­low patents to be waived in case of med­ical emer­gen­cies.

The In­tel­lec­tu­al Prop­er­ty Own­ers As­so­ci­a­tion sent a let­ter to Biden of­fi­cials ask­ing for their sup­port, Law360 re­port­ed Wednes­day. Should the bill be­come law in Brazil, the coun­try’s gov­ern­ment would have the au­thor­i­ty to break the patents with­out ap­proval from the ex­ec­u­tive branch.

Brazil’s low­er house of Con­gress ap­proved a draft of the bill at the be­gin­ning of Ju­ly, per a Reuters re­port from the time.

The WTO pro­pos­al ear­li­er this year came from In­dia and South Africa, with the coun­tries ar­gu­ing waiv­ing patents would help low­er- and mid­dle-in­come coun­tries get bet­ter ac­cess to shots and Covid-19 treat­ments. The US po­si­tion had orig­i­nal­ly been to op­pose the mea­sure, but Biden came out in sup­port in May.

That re­ver­sal prompt­ed sig­nif­i­cant push­back from phar­ma in­dus­try groups who ar­gued waiv­ing IP wouldn’t do much by way of pro­vid­ing ac­cess. Michelle Mc­Mur­ry-Heath, pres­i­dent and CEO of lob­by­ing group BIO, said at the time, “Hand­ing needy coun­tries a recipe book with­out the in­gre­di­ents, safe­guards, and siz­able work­force need­ed will not help peo­ple wait­ing for the vac­cine.”

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.