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.”

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.”