Covid-19 roundup: US to do­nate 20M more vac­cines over­seas; BerGen­Bio hopes for the best af­ter re­pur­pos­ing flop, tout­ing post hoc da­ta

Around 20 mil­lion more dos­es of the US-au­tho­rized Covid-19 vac­cines will be shipped over­seas in June, Pres­i­dent Joe Biden said Mon­day.

The do­na­tion comes as Biden promis­es a new ef­fort to in­crease sup­ply around the world. It’s the first time he’s pledged to give away dos­es that could be used in the US, The New York Times re­ports.

As the num­ber of cas­es and Covid-19 re­lat­ed deaths has plum­met­ed in the US, they have sky­rock­et­ed abroad, par­tic­u­lar­ly in In­dia. The 20 mil­lion dos­es are from Pfiz­er-BioN­Tech and J&J. In April, Biden pledged 60 mil­lion dos­es of As­traZeneca’s vac­cine, though they are not ap­proved for use in the US, and can’t be used un­til ruled safe by reg­u­la­tors.

Ad­vo­cates have called for coun­tries with a de­clin­ing num­ber of cas­es to do­nat­ed to Co­v­ax and in­crease man­u­fac­tur­ing plans in clos­er prox­im­i­ty to coun­tries that need help the most. — Josh Sul­li­van

Af­ter its re­pur­posed treat­ment flopped in PhII, BerGen­Bio rolls out new da­ta from post-hoc analy­sis

About a month af­ter ad­mit­ting that its re­pur­posed AXL in­hibitor failed the pri­ma­ry end­point in a Phase II Covid-19 study, BerGen­Bio says it has new da­ta show­ing the drug can in­crease the rate of ven­ti­la­tor-free sur­vival in more se­vere pa­tients. But there are still some ques­tions left unan­swered.

For one, BerGen­Bio didn’t re­lease any p-val­ues along with the new re­sults. And the da­ta are from a post-hoc analy­sis, which can be a tough sell at the FDA.

The Phase II tri­al, dubbed BG­BC020, en­rolled a to­tal of 115 hos­pi­tal­ized Covid-19 pa­tients in South Africa and In­dia. But this analy­sis was con­duct­ed in a sub­group of pa­tients (more than half of the orig­i­nal tri­al pop­u­la­tion) who had high­er base­line sever­i­ty, and C-Re­ac­tive Pro­tein (CRP) lev­els of greater than 30mg/L. CRP is a bio­mark­er used to de­tect acute in­flam­ma­tion, and in Covid-19 pa­tients, ris­ing CRP lev­els in the blood­stream in­di­cate in­creas­ing dis­ease sever­i­ty.

BerGen­Bio said 90% of pa­tients treat­ed with its AXL in­hibitor be­m­cen­tinib sur­vived to Day 29 with­out be­ing ad­mit­ted to the ICU or need­ing a ven­ti­la­tor, com­pared to just 72% of pa­tients giv­en stan­dard of care alone. The can­di­date was well-tol­er­at­ed, the Nor­we­gian com­pa­ny said, with no con­cern­ing safe­ty sig­nals not­ed.

How­ev­er, the pri­ma­ry end­point — time to im­prove­ment by two WHO grades from base­line, to time to dis­charge — didn’t reach sta­tis­ti­cal sig­nif­i­cance.

To eval­u­ate over­all sur­vival, BerGen­Bio com­bined the re­sults with the Phase II AC­CORD2 study, which was con­duct­ed in the UK with a sim­i­lar de­sign. Com­bined sur­vival to Day 29 was 96.5% (83 of 86 evalu­able pa­tients) in the be­m­cen­tinib arm ver­sus 91.0% (81 of 89 pa­tients) in the stan­dard of care arm.

“We will con­tin­ue our dis­cus­sion of these re­sults with the reg­u­la­tors, in­dus­try and Gov­ern­ment part­ners to de­ter­mine next steps,” CEO Richard God­frey said in a state­ment.

Be­m­cen­tinib is al­so be­ing test­ed alone and in com­bi­na­tion with oth­er ther­a­pies in sol­id and hema­to­log­i­cal tu­mors. — Nicole De­Feud­is

EMA up­dates shelf life of Pfiz­er’s vac­cine

As drug­mak­ers and gov­ern­ments are mak­ing an ef­fort to get Covid-19 vac­cines to more re­mote ar­eas, the Eu­ro­pean Med­i­cines Com­mit­tee has rec­om­mend­ed chang­ing the ap­proved stor­age pe­ri­od of Pfiz­er’s jab from five days to a month, the com­mit­tee an­nounced Mon­day.

The vac­cine still must be stored be­tween the tem­per­a­tures of 2 and 8 de­grees Cel­sius. The change will help the roll­out of vac­cines in EU coun­tries, the EMA said. It will al­so help re­duce the num­ber of vac­cines that are forced to be thrown out. Pre­vi­ous­ly, lo­cal vac­ci­na­tion sites were of­ten forced to dis­pose of the jabs if they were left thawed for too long.

At the end of April, Mod­er­na an­nounced that its own mR­NA vac­cine now has a 3-month re­frig­er­at­ed shelf life, up from the 1 month pre­vi­ous­ly ap­proved. Catal­ent, a CD­MO that is re­spon­si­ble for the man­u­fac­tur­ing of mil­lions of dos­es, en­tered a part­ner­ship with Ster­ling to pro­vide ul­tra-low tem­per­a­ture freez­ers for the preser­va­tion of dos­es en route to re­mote ar­eas that of­ten lack ad­e­quate re­frig­er­a­tion or elec­tric­i­ty. — Josh Sul­li­van

Vac­cine from Med­ica­go and GSK pro­duces pos­i­tive PhII re­sults

A Covid-19 vac­cine made in col­lab­o­ra­tion be­tween Med­ica­go and Glax­o­SmithK­line re­port­ed pos­i­tive Phase II tri­al da­ta Tues­day.

Near­ly 10 times the amount of an­ti­bod­ies were found in pa­tients dosed with the vac­cine than a pan­el of pa­tients re­cov­er­ing from the virus, the com­pa­nies an­nounced in a re­lease. There were no se­vere side ef­fects re­port­ed, and the side ef­fects re­port­ed were short and mild.

Phase III launched on March 16. Tri­al sites are en­rolling pa­tients in Cana­da, the US, the UK and Brazil. Each site en­rolled up to 306 pa­tients. The can­di­dates has been grant­ed fast track des­ig­na­tion by the FDA in the US, and Health Cana­da has ini­ti­at­ed a re­view un­der in­ter­im or­der.

The plant-de­rived vac­cine is made up of virus-like par­ti­cles, that pro­duce non-in­fec­tious ver­sions of the virus. The VLPs mim­ic the na­tive struc­ture of virus­es, which helps them be rec­og­nized by the im­mune sys­tem, Med­ica­go says on its web­site.

The com­pa­ny first pro­duced a VLP 20 days af­ter ob­tain­ing the virus. — Josh Sul­li­van

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

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Harith Rajagopalan (Fractyl)

Af­ter a decade in the Type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way Type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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75M vac­cine dos­es wast­ed: FDA spells out Emer­gent fa­cil­i­ty de­fi­cien­cies at length in new memo

The FDA is offering a fuller account of what went wrong at Emergent BioSolutions’ Covid-19 manufacturing facility in Baltimore, where the cross contamination of J&J and AstraZeneca vaccines led to the discarding of about 75 million vaccine doses.

CBER director Peter Marks released a memo on Saturday with new specifics, making clear up front that no vaccine manufactured at this plant has been distributed for use in the US yet.

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Covid-19 roundup: Re­al world da­ta sug­gest As­traZeneca vac­cine ef­fec­tive against Delta, Al­pha vari­ants; No­vavax hails pos­i­tive study on coro­n­avirus, flu shots com­bo

AstraZeneca’s Covid-19 vaccine, which has been authorized for use in the EU and Japan among many countries but not yet the US, has proved effective against the Delta variant, the company announced on Tuesday.

Real world data from Public Health England showed that the vaccine conferred high levels of protection against the variant that originated in India, as its 2 doses demonstrated 92% efficacy against hospitalization due to this variant. For the Alpha variant, which originated in the UK, the vaccine spurred a 86% reduction in hospitalization, with no deaths reported.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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