Covid-19 roundup: Ger­many puts J&J on the hot­seat for vac­cine back­o­rder; Top EMA of­fi­cial sug­gests for­go­ing As­traZeneca shot

Short­ly af­ter it was an­nounced that the FDA has re­quired J&J to dis­card tens of mil­lions of Covid-19 vac­cines that were con­t­a­m­i­nat­ed at an em­bat­tled Emer­gent plant in Bal­ti­more, MD, Ger­many has de­mand­ed that the com­pa­ny de­liv­er 6.5 mil­lion dos­es to make up for a short­fall, Reuters re­port­ed.

The FDA said Fri­day that two batch­es of the drug sub­stance used in J&J’s jab would be re­leased from quar­an­tine af­ter mil­lions of dos­es were held from dis­tri­b­u­tion at the Emer­gent site. While that frees up about 10 mil­lion dos­es, The New York Times re­port­ed Fri­day morn­ing an­oth­er 60 mil­lion dos­es were or­dered to be tossed out.

Emer­gent’s Bayview plant was pre­vi­ous­ly tak­en over by the FDA, caus­ing a sig­nif­i­cant short­age in J&J vac­cines be­ing shipped to coun­tries in need. Ger­many has been hit par­tic­u­lar­ly hard, as the coun­try was owed 10.1 mil­lion dos­es of the sin­gle-dose jab in the sec­ond quar­ter, the min­istry of health told Reuters.

In ad­di­tion to the quar­an­tined dos­es, Emer­gent was forced to halt any fur­ther pro­duc­tion as the FDA took over the Bal­ti­more Bayview plant to ob­serve its op­er­a­tions.

Top EMA of­fi­cial ad­vis­es against As­traZeneca’s jab

The EMA’s head of vac­cine strat­e­gy has rec­om­mend­ed the EU avoid As­traZeneca’s vac­cine in sit­u­a­tions in which an al­ter­na­tive is avail­able, The Brus­sels Times re­port­ed Mon­day. He al­so rec­om­mend­ed the J&J jab on­ly be used in pa­tients above the age of 60.

Mar­co Cav­a­leri made the com­ments to the Ital­ian news­pa­per La Stam­pa over the week­end. Italy re­strict­ed the use of As­traZeneca’s vac­cine in pa­tients un­der the age of 60 be­cause of the fear of rare but dan­ger­ous blood clots.

When asked if it was bet­ter to halt us­ing As­traZeneca al­to­geth­er for all age groups, Cav­a­leri agreed, and said that it’s an op­tion many coun­tries are tak­ing in­to con­sid­er­a­tion as the sup­ply of mR­NA vac­cines from Mod­er­na and Pfiz­er be­comes more read­i­ly avail­able.

PhI­II tri­al re­sults for Cell­tri­on’s an­ti­body treat­ment shows pos­i­tive re­sults

Cell­tri­on’s ex­per­i­men­tal Covid-19 an­ti­body treat­ment re­duced the treat­ment pe­ri­od for pa­tients by five days, the com­pa­ny an­nounced Mon­day.

The tri­als, which in­clud­ed pa­tients from 13 coun­tries in­clud­ing the US, South Ko­rea, Spain and Ro­ma­nia, were safe, the com­pa­ny said.

Rekirona gained South Ko­re­an reg­u­la­to­ry ap­proval in Feb­ru­ary, as it be­came the coun­try’s first lo­cal­ly made Covid-19 treat­ment. Phase III tri­al re­sults showed the an­ti­body re­duced the risk of the virus pro­gress­ing by 70%, Reuters said.

Cell­tri­on plans to sub­mit an ap­pli­ca­tion for reg­u­la­to­ry ap­proval with both the FDA and EMA in the com­ing months, The Ko­rea Her­ald re­ports.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

So­cial im­age: An­gela Merkel (AP Pho­to/Michael Sohn)

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.”