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.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

Hori­zon Ther­a­peu­tics in takeover talks with Am­gen, J&J, Sanofi as po­ten­tial buy­ers

Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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Sana, Codex­is lay off staff, reshuf­fle pipeline in bid to fo­cus cell ther­a­py, en­zyme en­gi­neer­ing work

As its market cap shrinks to a fraction of its heyday, flashy cell therapy startup Sana Biotechnology is laying off 15% of its staffers in a move to rejig the pipeline and restructure the company.

Sana is among a growing group of biotechs that, feeling the weight of a broader market downturn and seeing their shares tumble steadily, are tightening the purse strings and adjusting their focus. Also on Tuesday, Codexis, an enzyme engineering company based in California and now helmed by former Sierra Oncology CEO Stephen Dilly, announced it will reduce the workforce by 18%.

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Jeb Keiper, Nimbus Therapeutics CEO

PhI­Ib win puts Nim­bus one step clos­er to chal­leng­ing Bris­tol My­ers in TYK2

Bristol Myers Squibb might be the first to clinch an FDA approval for a TYK2 inhibitor, but Nimbus Therapeutics is out to prove that it has the best drug in the class. The biotech says it now has positive mid-stage data to back up those claims — although it’s saving the hard numbers for now.

Topline results from a Phase IIb study involving 259 patients with moderate-to-severe plaque psoriasis showed that Nimbus’ drug, NDI-034858, hit the primary endpoint of helping more patients achieve PASI-75 than placebo at 12 weeks.

John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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