Stéphane Bancel at the Endpoints #JPM20 breakfast panel in San Francisco, January 2020 (Photo: Jeff Rumans, Endpoints News)

Mod­er­na says Covid-19 vac­cine boost­er in­creased im­mune re­sponse against vari­ants of con­cern

About a month af­ter an­nounc­ing their vari­ant-spe­cif­ic Covid-19 vac­cine boost­ers showed promis­ing re­sults in mice, Mod­er­na says it now has some hu­man da­ta to back it up.

Vol­un­teers giv­en a boost­er shot about six to eight months af­ter re­ceiv­ing their sec­ond dose saw in­creased an­ti­body lev­els against SARS-CoV-2 and two vari­ants of con­cern: B.1.351, which was first iden­ti­fied in South Africa, and P.1, first iden­ti­fied in Brazil, the com­pa­ny said on Wednes­day.

The analy­sis came from par­tic­i­pants who were giv­en ei­ther a third dose of mR­NA-1273 (the orig­i­nal vac­cine cur­rent­ly au­tho­rized in the US), or mR­NA-1273.351, a strain-matched boost­er tar­get­ing the B.1.351 vari­ant. Mod­er­na is cur­rent­ly test­ing mR­NA-1273.211 — a 50/50 com­bi­na­tion of mR­NA 1273 and mR­NA-1273.351 — in a dif­fer­ent arm of the Phase II study.

Fol­low­ing a boost of ei­ther mR­NA-1273 or mR­NA-1273.351, par­tic­i­pants’ neu­tral­iz­ing an­ti­bod­ies in­creased to lev­els sim­i­lar to or high­er than those seen against the an­ces­tral strain af­ter first vac­ci­na­tion, Mod­er­na said. Fif­teen days post-boost­er, the vari­ant-spe­cif­ic shot ap­peared to be more ef­fec­tive than the orig­i­nal vac­cine at in­creas­ing an­ti­body lev­els against the B.1.351 strain, pro­duc­ing geo­met­ric mean titer lev­els more than one-and-a-half times high­er than mR­NA-1273.

Al­so from the re­sults:

The rel­a­tive de­crease in neu­tral­iz­ing titers be­tween the wild-type (D614G) and B.1.351 as­says al­so im­proved with mR­NA-1273.351 boost­er, from a 7.7-fold dif­fer­ence pri­or to boost to a 2.6-fold dif­fer­ence 15 days af­ter  boost, sug­gest­ing a po­ten­tial­ly more bal­anced im­mune re­sponse against the test­ed vari­ants.

Safe­ty and tol­er­a­bil­i­ty da­ta were “gen­er­al­ly com­pa­ra­ble” to those seen af­ter the sec­ond dose of the orig­i­nal vac­cine in pre­vi­ous Phase II and III tri­als, Mod­er­na said. The re­sults have been sub­mit­ted as a preprint to bioRx­iv, and will be sub­mit­ted for peer-re­viewed pub­li­ca­tion af­ter Mod­er­na wraps up the mR­NA-1273.211 por­tion of the study.

“We are en­cour­aged by these new da­ta, which re­in­force our con­fi­dence that our boost­er  strat­e­gy should be pro­tec­tive against these new­ly de­tect­ed vari­ants. The strong and rapid boost in titers  to lev­els above pri­ma­ry vac­ci­na­tion al­so clear­ly demon­strates the abil­i­ty of mR­NA-1273 to in­duce im­mune mem­o­ry,” CEO Stéphane Ban­cel said in a state­ment.

Ban­cel told End­points News last month that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, due to the fact that many peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. He be­lieves there will be a need for sev­er­al boosts over the next cou­ple years, “es­pe­cial­ly peo­ple at high risk.” Then in 2023 or 2024, as the speed at which the vac­cine mu­tates slows down, a boost per year might be enough, he said.

“Our mR­NA plat­form  al­lows for rapid de­sign of vac­cine can­di­dates that in­cor­po­rate key virus mu­ta­tions, po­ten­tial­ly al­low­ing  for faster de­vel­op­ment of fu­ture al­ter­na­tive vari­ant-matched vac­cines should they be need­ed,” Ban­cel said Wednes­day.

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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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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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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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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