Vac­citech con­fi­den­tial­ly files for Nas­daq IPO — re­port; Sanofi recom­mits to so­cial caus­es, launch­es glob­al non­prof­it

An­oth­er biotech is re­port­ed­ly head­ed to Nas­daq, one that plays a promi­nent role in the Covid-19 vac­cine race.

Com­ing from the shores of Britain, Vac­citech con­fi­den­tial­ly filed for an IPO on Wednes­day, per a re­port from the Fi­nan­cial Times. The com­pa­ny hasn’t filed any pa­per­work with the SEC just yet, and it’s un­clear what kind of raise they’re es­ti­mat­ing. FT not­ed that the com­pa­ny could price as ear­ly as this month, how­ev­er.

Sarah Gilbert

Vac­citech is the biotech be­hind the As­traZeneca/Ox­ford Uni­ver­si­ty Covid-19 vac­cine, own­ing the tech­nol­o­gy that drove the shot’s de­vel­op­ment. Its co-founder, Sarah Gilbert, al­so led the re­search in­to the vac­cine.

Just a few weeks ago, Vac­citech pulled in a mon­ster $168 mil­lion Se­ries B, led by Lon­don in­vest­ment firm M&G and joined by Gilead and Ten­cent, among oth­ers. Val­ued as lit­tle as $86 mil­lion back in 2019, Vac­citech is now val­ued at over $450 mil­lion thanks to the March raise. The com­pa­ny had orig­i­nal­ly been work­ing on a MERS vac­cine, which they then used as a pi­lot pro­gram for the Covid-19 re­search.

IPO cash has been flow­ing in­to biotech over the last 12 months, with 2020 record­ing a record raise for the sec­tor. That’s on­ly con­tin­ued through the first quar­ter of 2021, with more than two dozen com­pa­nies rais­ing a com­bined $4.64 bil­lion so far.

But op­ti­mism for Vac­citech may be lim­it­ed as con­cerns linger over the As­traZeneca/Ox­ford vac­cine. The Big Phar­ma paused its vac­cine tri­al in chil­dren Tues­day as reg­u­la­tors con­tin­ue to look in­to a pos­si­ble link be­tween the shot and blood clot events.

Sanofi launch­es glob­al non­prof­it as part of new so­cial push

Sanofi is ex­pand­ing its so­cial com­mit­ments and cre­at­ing a new non­prof­it to de­liv­er es­sen­tial med­i­cines to poor­er na­tions, CEO Paul Hud­son an­nounced in an open let­ter Wednes­day.

Paul Hud­son

The non­prof­it, to be called Sanofi Glob­al Health, is aimed at in­creas­ing ac­cess to med­i­cines con­sid­ered es­sen­tial by the WHO for pa­tients in 40 low­er in­come coun­tries. 30 of Sanofi’s ther­a­peu­tics will be pro­vid­ed across a range of dis­eases, in­clud­ing car­dio­vas­cu­lar dis­ease, di­a­betes, tu­ber­cu­lo­sis, malar­ia and can­cer.

Sanofi Glob­al Health will al­so help train health­care pro­fes­sion­als and set up and de­vel­op sus­tain­able care sys­tems for those who suf­fer from chron­ic dis­eases. Sanofi says this is the first ef­fort of its kind to pro­vide as broad a port­fo­lio as de­tailed in Hud­son’s let­ter.

In ad­di­tion to the non­prof­it, Sanofi is al­so recom­mit­ting to in­crease di­ver­si­ty with­in its work­force and elim­i­nate plas­tic pack­ag­ing for vac­cines and oth­er prod­ucts.

“Through­out this pan­dem­ic, pub­lic au­thor­i­ties, sci­en­tists, and in­dus­try have worked close­ly to­geth­er to dis­cov­er and pro­duce vac­cines at a pace that has de­fied his­tor­i­cal prece­dent,” Hud­son wrote. “We now have to ap­ply this same sense of ur­gency to oth­er press­ing threats, such as cli­mate change, and is­sues that the pan­dem­ic has sharply put in­to fo­cus, in­clud­ing widen­ing racial and health­care in­equal­i­ties.”

Tysabri in­jec­tions OK’ed in Eu­rope

Bio­gen ex­pand­ed its Tysabri fran­chise in Eu­rope on Wednes­day, win­ning a new ap­proval from the Eu­ro­pean Com­mis­sion to treat re­laps­ing-re­mit­ting mul­ti­ple scle­ro­sis through sub­cu­ta­neous in­jec­tion.

The new ad­min­is­tra­tion method com­pares sim­i­lar­ly in both safe­ty and ef­fi­ca­cy to Tysabri’s IV for­mu­la­tion, Bio­gen said in its an­nounce­ment. The com­pa­ny says it’s now the on­ly high-ef­fi­ca­cy MS ther­a­py to of­fer two dif­fer­ent ad­min­is­tra­tion op­tions.

Like the IV in­fu­sion, the Tysabri in­jec­tions are dosed at 300 mg every four weeks by a health­care provider. The aim of the new method is to ex­pand the clin­i­cal set­tings in which pa­tients can be treat­ed be­yond in­fu­sion cen­ters, es­pe­cial­ly with the Covid-19 pan­dem­ic still in full swing.

Tysabri was orig­i­nal­ly ap­proved in Eu­rope back in 2006.

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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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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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.

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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Mer­ck­'s wom­en's health spin­out snags mid-stage can­di­date for preterm birth; Keytru­da nails down TNBC ap­proval af­ter March CRL

Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal.

Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions.

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.

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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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.