FDA spells out how the Covid-19 vari­ants im­pact the ef­fec­tive­ness of Re­gen­eron, Eli Lil­ly mAb treat­ments

The FDA on Thurs­day af­ter­noon up­dat­ed its three fact sheets on the mon­o­clon­al an­ti­body treat­ments from Eli Lil­ly and Re­gen­eron, of­fer­ing new da­ta on the sus­cep­ti­bil­i­ty of the SARS-CoV-2 vari­ants orig­i­nat­ing in the UK, Brazil, South Africa, Cal­i­for­nia and New York to each of the mAb ther­a­pies.

“Some vari­ants can cause re­sis­tance to one or more of the mAb ther­a­pies au­tho­rized to treat COVID-19,” FDA said. “Health care providers should re­view the au­tho­rized fact sheets for in­for­ma­tion on the use of the au­tho­rized mAb ther­a­pies against cur­rent­ly cir­cu­lat­ing vi­ral vari­ants.”

For Lil­ly’s bam­lanivimab alone, which is no longer be­ing dis­trib­uted by the US gov­ern­ment in Cal­i­for­nia, Neva­da and Ari­zona be­cause of the vari­ant orig­i­nat­ing in Cal­i­for­nia, the FDA not­ed in its re­vised fact sheet ma­jor re­duc­tions in sus­cep­ti­bil­i­ty for all of the vari­ants stud­ied, ex­cept for the one orig­i­nat­ing in the UK. Al­most 800,000 cours­es of bam­lanivimab have now been dis­trib­uted across the US, in­clud­ing more than 100,000 cours­es to Cal­i­for­nia, Neva­da and Ari­zona.

But for Lil­ly’s com­bi­na­tion ther­a­py of bam­lanivimab and ete­se­vimab, the up­dat­ed fact sheet showed the treat­ment fared bet­ter against all of the vari­ants than bam­lanivimab alone. A Lil­ly spokesper­son said in a state­ment: “It has al­ways been our view that ad­di­tion­al an­ti­bod­ies from Lil­ly and oth­ers will need to be de­vel­oped to ad­dress the evo­lu­tion of the virus, in­clud­ing emerg­ing vari­ants that can dif­fer by coun­try or even by state. In fact, this is what drove our work on bam­lanivimab and ete­se­vimab to­geth­er and con­tin­ues to un­der­pin our strat­e­gy mov­ing for­ward.”

And Re­gen­eron’s mAb com­bi­na­tion of casiriv­imab with imde­vimab showed the least re­duc­tion in sus­cep­ti­bil­i­ty against the vari­ants, ac­cord­ing to its up­dat­ed fact sheet. Through Feb. 2, the US says it’s al­lo­cat­ed 148,022 dos­es of the Re­gen­eron mAb cock­tail.

“FDA is re­quired to reg­u­lar­ly re­view the cir­cum­stances and ap­pro­pri­ate­ness of an EUA, and the agency con­tin­ues to re­view emerg­ing sci­en­tif­ic in­for­ma­tion as­so­ci­at­ed with the emer­gency us­es for the au­tho­rized mAb prod­ucts, in­clud­ing in­for­ma­tion on vi­ral vari­ants,” the agency said in a state­ment. “FDA is com­mit­ted to pro­vid­ing up­dat­ed in­for­ma­tion on vari­ants and their po­ten­tial im­pact on the au­tho­rized mAb ther­a­pies as new in­for­ma­tion be­comes avail­able.”

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

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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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.

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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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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With few re­main­ing un­ap­proved drugs, re­searchers tell FDA its Un­ap­proved Drugs Ini­tia­tive is no longer ef­fec­tive

Back in May, the FDA decided to reverse a Trump-era decision to pull the agency’s controversial Unapproved Drugs Initiative, with the FDA citing “multiple legal and factual inaccuracies.”

But now a group of researchers from Harvard, funded by Arnold Ventures, raises new questions about why the UDI program might not be necessary in its current form.

Designed in 2006 as a way for the FDA to transition old drugs from unapproved to approved products, the agency sought to better ensure that unsafe products were removed from the market.

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