Covid-19 roundup: As­traZeneca's Farx­i­ga fails PhI­II test; Sup­ply deal for Eli Lil­ly's so­lo bam­lanivimab of­fi­cial­ly can­celed

Around the same time As­traZeneca struck up a vac­cine part­ner­ship with Ox­ford last April, the phar­ma gi­ant al­so put to­geth­er a game plan to de­vel­op treat­ments — both new and re­pur­posed — for Covid-19. One of them has now end­ed in fail­ure.

The Phase III DARE-19 tri­al re­cruit­ed 1,250 pa­tients hos­pi­tal­ized with Covid-19 over the past year and gave half of them the di­a­betes drug Farx­i­ga on top of stan­dard of care ther­a­py.

When com­pared to those re­ceiv­ing place­bo, the drug didn’t hit sta­tis­ti­cal sig­nif­i­cance in ei­ther of the pri­ma­ry end­points: pre­vent­ing mea­sur­ing or­gan dys­func­tion and all cause mor­tal­i­ty, or im­prov­ing re­cov­ery (as mea­sured by a change in clin­i­cal sta­tus) at 30 days.

Fo­cus­ing on the bright side, Mene Pan­ga­los, EVP of bio­phar­ma­ceu­ti­cals R&D, not­ed: “Pri­or to the DARE-19 Phase III tri­al, there was lit­tle da­ta on the use of SGLT2 in­hibitors in hos­pi­talised pa­tients with COVID-19 and we have now helped to fill this knowl­edge gap.”

Mikhail Kosi­borod, the prin­ci­pal in­ves­ti­ga­tor of the tri­al and the VP of re­search at As­traZeneca part­ner Saint Luke’s Mid Amer­i­ca Heart In­sti­tute, echoed Pan­ga­los and called the find­ings “very in­ter­est­ing and valu­able.” De­tails are due to be re­leased at the Amer­i­can Col­lege of Car­di­ol­o­gy Sci­en­tif­ic Ses­sions in May.

While orig­i­nal­ly de­signed as a di­a­betes pill, Farx­i­ga has been shown across large stud­ies to have car­dio and re­nal pro­tec­tive ef­fects not just in that pop­u­la­tion but al­so for those with heart fail­ure with re­duced ejec­tion frac­tion and chron­ic kid­ney dis­ease (CKD). Co­in­ci­den­tal­ly, sci­en­tists had ob­served that Covid-19 pa­tients with “car­diac, re­nal and meta­bol­ic co­mor­bidi­ties” tend­ed to have poor out­comes — lead­ing As­traZeneca to test whether Farx­i­ga may help in this set­ting as well.

Like a slew of oth­er com­mer­cial drugs that bio­phar­ma com­pa­nies big and small tried to re­pur­pose, it didn’t. As­traZeneca it­self has al­ready con­clud­ed that Calquence, the block­buster BTK in­hibitor ap­proved for can­cer, made lit­tle dif­fer­ence in mor­tal­i­ty or sav­ing Covid-19 pa­tients from res­pi­ra­to­ry fail­ure.

While the phar­ma gi­ant didn’t spec­i­fy the next steps, it seems to im­ply that this will mark the end of the Farx­i­ga pro­gram in Covid-19.

US gov­ern­ment re­jigs an­ti­body sup­ply deal with Eli Lil­ly 

Days af­ter the US gov­ern­ment and Eli Lil­ly agreed to halt all dis­tri­b­u­tion of bam­lanivimab as a monother­a­py, the com­pa­ny said of­fi­cials have of­fi­cial­ly re­vised the an­ti­body sup­ply deal.

That means the pur­chase agree­ment for bam­lanivimab will be ter­mi­nat­ed, the com­pa­ny said in a state­ment, can­cel­ing the planned de­liv­ery of 350,836 dos­es the orig­i­nal agree­ment had called for.

Con­cerns of bam­lanivimab’s di­min­ished ef­fi­ca­cy against cer­tain coro­n­avirus vari­ants first led the US to stop di­rect or­der­ing of bam­lanivimab alone in three states, be­fore ex­tend­ing that ban to the whole coun­try. In­stead, hos­pi­tals could or­der ei­ther bam­lanivimab and ete­se­vimab to­geth­er or ete­se­vimab alone to pair with any re­main­ing dos­es of bam­lanivimab on hand.

The arrange­ment is now cod­i­fied in the mod­i­fied con­tract.

First de­vel­oped by Ab­Cellera, bam­lanivimab was the first mon­o­clon­al an­ti­body to gain an emer­gency use au­tho­riza­tion at the FDA. Lil­ly sub­se­quent­ly paired it with ete­se­vimab, which orig­i­nat­ed from Chi­na’s Jun­shi, gen­er­at­ing a sol­id slate of com­bo da­ta that led to an­oth­er EUA, al­so for mild to mod­er­ate Covid-19. To­geth­er, the two reg­i­mens were the sub­ject of a $1.2 bil­lion sup­ply deal.

As con­cerns grew that cer­tain vari­ants could evade an­ti­body treat­ments, the FDA has di­rect­ed both Lil­ly and Re­gen­eron to mon­i­tor ge­nom­ic data­base(s) for the emer­gence of glob­al vi­ral vari­ants and track how well their drugs can tack­le those vari­ants.

Chi­na is ready to join the mR­NA race

As Fo­s­un Phar­ma pre­pares to push BioN­Tech’s Covid-19 vac­cine to­ward an ap­proval in Chi­na, a se­nior in­dus­try fig­ure says home­grown mR­NA play­ers will al­so be ready to jump in the game soon.

“We ful­ly ex­pect that there is a high pos­si­bil­i­ty that a do­mes­tic mR­NA vac­cine will hit the mar­ket by this year,” Feng Duo­jia, pres­i­dent of the Chi­na As­so­ci­a­tion of Vac­cines, told the South Chi­na Morn­ing Post.

One can­di­date joint­ly de­vel­oped by the Acad­e­my of Mil­i­tary Sci­ence, Wal­vax Biotech­nol­o­gy and Suzhou Abo­gen Bio­sciences has been through Phase II tri­als with “sat­is­fac­to­ry” re­sults, he said, with Phase III tri­als un­der­way over­seas. An­oth­er from Shang­hai-based Stemir­na went in­to the clin­ic last month.

Fo­s­un, mean­while, is sort­ing through da­ta from Phase II tri­als con­duct­ed in Jiang­su province, SCMP re­port­ed. The plan is to com­bine those with Phase III re­sults from over­seas in its reg­u­la­to­ry fil­ing.

While Fo­s­un start­ed off as the de­vel­op­er and dis­trib­u­tor of BioN­Tech’s vac­cines — hav­ing start­ed de­liv­er­ing dos­es made in Ger­many to Hong Kong and Macau — the com­pa­ny has inked a deal to pro­duce lo­cal­ly.

“The prepa­ra­tions at the pro­duc­tion fa­cil­i­ty are ready,” Feng added. “Af­ter ef­fec­tive re­sults are ob­tained through these tri­als, an ap­pli­ca­tion will be sub­mit­ted to the rel­e­vant gov­ern­ment agency im­me­di­ate­ly, with the hope to start do­mes­tic pro­duc­tion of the for­eign vac­cine in Chi­na.”

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

How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Ryan Watts, Denali CEO

De­nali slips as a snap­shot of ear­ly da­ta rais­es some trou­bling ques­tions on its pi­o­neer­ing blood-brain bar­ri­er neu­ro work

Denali Therapeutics had drummed up considerable hype for their blood-brain barrier technology since launching over six years ago, hype that’s only intensified in the last 14 months following the publications of a pair of papers last spring and proof of concept data earlier this year. On Sunday, the South San Francisco-based biotech gave the biopharma world the next look at in-human data for its lead candidate in Hunter syndrome.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.

Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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