Joanna Shields, BenevolentAI CEO (Andreas Gebert/picture-alliance/dpa/AP Images)

Af­ter nab­bing two AI-gen­er­at­ed mol­e­cules, As­traZeneca re­turns to Benev­o­len­tAI with new col­lab­o­ra­tion

Rough­ly three years ago, As­traZeneca teamed up with Lon­don’s Benev­o­len­tAI to bring new drugs in­to its port­fo­lio us­ing the biotech’s AI and ma­chine learn­ing ca­pa­bil­i­ties. Now that the orig­i­nal deal has borne fruit, the two com­pa­nies are re-up­ping their col­lab­o­ra­tion.

As­traZeneca and Benev­o­len­tAI will work to­geth­er in two more dis­ease ar­eas: sys­temic lu­pus and heart fail­ure, the com­pa­nies an­nounced Thurs­day. It’s a three-year part­ner­ship that comes af­ter two can­di­dates dis­cov­ered by Benev­o­len­tAI for chron­ic kid­ney dis­ease and id­io­path­ic pul­monary fi­bro­sis were nom­i­nat­ed to As­traZeneca’s port­fo­lio last year.

No fi­nan­cials were dis­closed, but Benev­o­len­tAI CSO Anne Phe­lan told End­points News there would be an up­front pay­ment, an eq­ui­ty in­vest­ment and mile­stones.

The orig­i­nal part­ner­ship proved a sig­nif­i­cant mile­stone for As­traZeneca, as the CKD mol­e­cule nom­i­nat­ed last Jan­u­ary was the com­pa­ny’s first gen­er­at­ed by AI. At the time, As­traZeneca iden­ti­fied and val­i­dat­ed a new way to at­tack CKD thanks to the biotech’s plat­form AI tech, and be­gan de­vel­op­ing com­pounds cen­tered on this tar­get.

The IPF com­pound fol­lowed up just last month, and now marks the “per­fect time” to ex­tend the work­ing re­la­tion­ship, Phe­lan said.

Lu­pus and heart fail­ure “fall with­in [As­traZeneca’s] pri­or­i­ty ther­a­peu­tic ar­eas,” Phe­lan said. “They’re com­plex dis­eases, dif­fi­cult spaces to work in. It’s a tricky prob­lem that lends it­self well to AI and our ma­chine learn­ing ca­pa­bil­i­ties.”

At the heart of Benev­o­len­tAI’s tech­nol­o­gy is what Phe­lan de­scribes as a “knowl­edge graph,” which es­sen­tial­ly looks like a “hair­ball” net­work of thou­sands of da­ta points, or nodes, in­ter­con­nect­ed by mil­lions of lines or re­la­tion­ships. Such re­la­tion­ships are first iden­ti­fied by the ma­chine learn­ing al­go­rithms and can con­nect many dif­fer­ent and un­re­lat­ed dis­eases.

Anne Phe­lan

Benev­o­len­tAI is able to dif­fer­en­ti­ate it­self from the buzzy and grow­ing field of AI drug de­vel­op­ment be­cause it is dri­ven by a hy­poth­e­sis-first ap­proach rather than fo­cus­ing on phe­no­typ­ic screen­ing, Phe­lan added. Where­as com­peti­tors’ AI might be mak­ing new mol­e­cules and try­ing to re­verse-en­gi­neer the process, Benev­o­len­tAI starts from scratch.

“It’s not a right and wrong sit­u­a­tion … it’s a re­al­ly mul­ti­di­men­sion­al pic­ture of hu­man bi­ol­o­gy across the com­mon­al­i­ties of hu­man dis­ease,” Phe­lan said. “For ex­am­ple, de­pend­ing on the cell type that’s af­fect­ed, the graph could end up con­nect­ing to Alzheimer’s or di­a­betes, where un­der­ly­ing phys­i­ol­o­gy could be re­al­ly quite sim­i­lar.”

For As­traZeneca, lu­pus re­cent­ly turned in­to a po­ten­tial mon­ey­mak­er, as the Big Phar­ma whisked a new drug past the FDA fin­ish line last Au­gust in Saph­ne­lo. It’s the first new lu­pus ap­proval in at least the last 10 years, As­traZeneca said at the time, and re­duces over­all dis­ease ac­tiv­i­ty across or­gan sys­tems and oral cor­ti­cos­teroid use com­pared to place­bo.

Heart fail­ure, mean­while, is an area where As­traZeneca is look­ing to stake out a block­buster with Farx­i­ga. Back in 2020, the drug was ap­proved to re­duce the risk of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion in heart fail­ure pa­tients with a re­duced ejec­tion frac­tion. It al­so picked up an ap­proval in CKD last April.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

invoX Pharma CEO Ben Toogood (L) and F-star CEO Eliot Forster

F-star bought out in $161M all-cash deal as Hong Kong's Sino Bio­pharm looks to­ward in­ter­na­tion­al ex­pan­sion

After more than a decade and a half of charting its own course, F-star Therapeutics will now settle under a new umbrella company.

The UK biotech will be acquired by invoX Pharma, a subsidiary of Hong Kong’s Sino Biopharm, in a roughly $161 million all-cash deal, the companies announced Thursday morning. F-star’s buyout will value its shares $FSTX at $7.12 apiece, nearly an 80% premium above Wednesday’s closing price.

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GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

FDA un­veils new draft guid­ance to help with oligonu­cleotide ther­a­peu­tics de­vel­op­ment

While oligonucleotides, a wide variety of synthetically modified RNA or RNA/DNA hybrids that bind to a target RNA sequence to alter RNA and/or protein expression, have been winning approvals in recent years (e.g. Novartis’ cholesterol drug Leqvio), the regulatory agency is offering new draft guidance for those looking to follow a similar path.

The non-binding guidance, titled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics Guidance for Industry” deals with pharmacokinetic, pharmacodynamic, and safety assessments required as part of oligonucleotide therapeutics R&D.

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Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.