Atul Deshpande, Jingsong Wang (file photo)

Ab­b­Vie pulls the trig­ger on a Covid-19 an­ti­body, go­ing all in on a drug dis­cov­ered by re­search al­liance

With mul­ti­ple re­pur­posed Covid-19 treat­ments al­ready in the clin­ic (and one that flunked out), Ab­b­Vie is plac­ing its next bet on some­thing new: an ex­per­i­men­tal an­ti­body it spent the last sev­er­al months de­vel­op­ing with Har­bour Bio­Med, the Nether­lands’ Utrecht Uni­ver­si­ty and Eras­mus Med­ical Cen­ter.

Ab­b­Vie joined the an­ti­body hunt back in June, with its sights set on Har­bour’s 47D11. The Illi­nois-based phar­ma is now putting down a one-time li­cense fee for world­wide de­vel­op­ment and com­mer­cial­iza­tion rights to the an­ti­body, which it says shows promise in not on­ly SARS-CoV-2, but al­so re­lat­ed mu­ta­tions of the virus and SARS-CoV-1. It dosed the first pa­tient in a 24-per­son Phase I tri­al just last week.

Har­bour and Utrecht are keep­ing qui­et about the terms of the li­cens­ing deal, ex­cept to note that they’ll re­ceive cer­tain mile­stone pay­ments and tiered roy­al­ties on net sales. Eras­mus wasn’t in­volved in the deal.

47D11 was dis­cov­ered last year us­ing the Har­bour Mice plat­form, and was orig­i­nal­ly in de­vel­op­ment for SARS-CoV-1. Then the pan­dem­ic struck, and Har­bour CEO Jing­song Wang said the com­pa­nies re­al­ized its po­ten­tial for SARS-CoV-2. It tar­gets a con­served re­gion of the SARS-CoV-2 spike pro­tein, and Wang said there’s a pos­si­bil­i­ty it could be used to treat oth­er coro­n­avirus­es as well.

“Of course, we’ll need fur­ther val­i­da­tion,” he added.

The study will test the an­ti­body in three dif­fer­ent dos­es at test sites across the US, with safe­ty as the pri­ma­ry end­point. Har­bour said they ex­pect the tri­al to wrap up around May.

Al­though Ab­b­Vie didn’t have much pri­or ex­pe­ri­ence in de­vel­op­ing an­ti­bod­ies for virus­es, much of their oth­er work cen­ters on an­ti­bod­ies, like the TNF-block­ing an­ti­body Hu­mi­ra.

Ab­b­Vie’s ceni­crivi­roc — which has shown to be un­der­whelm­ing as a NASH treat­ment — was se­lect­ed by the NIH in Oc­to­ber for a new AC­TIV-1 Im­mune Mod­u­la­tors adap­tive study, in an ef­fort to find new ways to stave off the cy­tokine storms that kill some pa­tients. Its IL-23 drug with Boehringer In­gel­heim was al­so cho­sen for an NIH study for Covid-19.

An­oth­er of the com­pa­ny’s ef­forts to fight the pan­dem­ic proved un­suc­cess­ful back in June, when UK RE­COV­ERY tri­al in­ves­ti­ga­tors con­clud­ed that the HIV an­tivi­ral Kale­tra was in­ef­fec­tive against Covid-19. For 1,596 pa­tients giv­en the drug, the 28-day mor­tal­i­ty rate was 22.1%, com­pared to 21.3% for the 3,376 who re­ceived stan­dard care.

Go­ing forth, AB­BV-47D11 may al­so be test­ed as a pre­ven­ta­tive ther­a­py. “That is some­thing that is be­ing re­viewed and dis­cussed in­ter­nal­ly at this point,” Har­bour chief strat­e­gy of­fi­cer and head of US op­er­a­tions At­ul Desh­pande said.

“We’re re­al­ly ex­cit­ed to con­tribute to the on­go­ing pan­dem­ic in face of all the chal­lenges that all of us glob­al­ly are fac­ing,” Wang said.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Mod­er­na's Stéphane Ban­cel plans to dou­ble down on vac­cine pro­duc­tion, new vari­ants as mR­NA rules in pan­dem­ic fight

Stéphane Bancel thought he’d be sleeping more by now.

The 48-year-old Moderna CEO figured that by 2021 he’d have his vaccine through the clinic, authorized, and in mass production — that the hard part would be over. Instead, he’s still working Saturdays and Sundays, talking with his lab and manufacturing teams and fielding calls with two to three world leaders a day to answer their concerns about supply and emerging new variants.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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