As­traZeneca scores new goal on the pipeline front, adding its first AI-gen­er­at­ed tar­get to the port­fo­lio

As more and more bio­phar­mas de­vel­op ar­ti­fi­cial in­tel­li­gence plat­forms, the drug dis­cov­ery process is be­ing re­shaped to fit new goals on cut­ting down the prodi­gious amount of time, en­er­gy and mon­ey that go in­to a drug pro­gram. Now one of the most am­bi­tious play­ers in the dri­ve to im­prove on ROI, As­traZeneca, is mark­ing a mile­stone on that front by adding the first tar­get gen­er­at­ed by AI to its port­fo­lio.

The tar­get comes out of a col­lab­o­ra­tion with Benev­o­len­tAI, a Lon­don-based com­pa­ny that first start­ed work­ing with the big phar­ma back in April, 2019. Thanks to the biotech’s plat­form AI tech, As­traZeneca has iden­ti­fied and val­i­dat­ed a new way to at­tack chron­ic kid­ney dis­ease and will be­gin de­vel­op­ing com­pounds cen­tered on this tar­get.

This se­lec­tion fits in­to a broad­er AI strat­e­gy at As­traZeneca, the com­pa­ny’s re­nal bio­sciences chief told End­points News. And the plan isn’t to just lim­it its ap­pli­ca­tions to R&D.

“We’re in­vest­ing in AI and see it as a clear tool that can sup­port our de­ci­sions in drug dis­cov­ery,” Pernille Hansen said. “They can be not on­ly for dis­cov­er­ing new tar­gets, it can be in chem­istry, imag­ing and so forth. So there’s many, many pos­si­bil­i­ties to work with AI.”

But they’re still a long way out from prov­ing AI can of­fer tan­gi­ble ev­i­dence of an im­pact.

Pernille Hansen

Hansen de­clined to say what specif­i­cal­ly the tar­get is, what kinds of drugs will uti­lize it to treat CKD or the time­line for such drug de­vel­op­ment. The on­ly thing she’d dis­close is that it suits their re­nal and AI ap­proach­es, and that As­traZeneca re­searchers have giv­en the OK to ad­vance.

Kid­ney dis­ease is a fa­mil­iar area for the com­pa­ny, giv­en its stud­ies to ex­pand its block­buster Farx­i­ga drug in­to CKD over the last sev­er­al years. A Phase III tri­al in the dis­ease was halt­ed in March over what As­traZeneca deemed “over­whelm­ing ef­fi­ca­cy,” and the com­pa­ny re­leased topline re­sults in Ju­ly. The FDA has set a rough re­view date for some­time dur­ing the sec­ond quar­ter.

If Farx­i­ga does cross the fin­ish line in CKD, it would rep­re­sent a sec­ond ap­proval once thought un­like­ly for a drug class de­vel­oped for di­a­betes. The drug was ap­proved in May to re­duce the risk of car­dio­vas­cu­lar death or hos­pi­tal­iza­tion in heart fail­ure pa­tients with a re­duced ejec­tion frac­tion, and those with or with­out type 2 di­a­betes.

Ivan Grif­fin

Wednes­day’s tar­get, though, comes out of Benev­o­len­tAI’s plat­form, which es­sen­tial­ly forms the shape of a “knowl­edge graph,” COO Ivan Grif­fin told End­points News. Grif­fin’s com­pa­ny has spent years feed­ing its tech with all sorts of da­ta, from pro­teins and genes to re­sults pub­lished in sci­en­tif­ic jour­nals, and train­ing its al­go­rithm to make con­nec­tions that sci­en­tists may not have no­ticed at first.

One could vi­su­al­ize such the graph as an in­ter­con­nect­ed web of “nodes and edges,” Grif­fin said. Sci­en­tists take ad­van­tage of the AI-pre­dict­ed re­la­tion­ships and then in­ter­ro­gate them to see if it holds up, which is what hap­pened in As­traZeneca’s case.

“The strengths we have in the da­ta and AI and ma­chine learn­ing tech­nol­o­gy ap­proach match­es re­al­ly nice­ly, in this case, with what As­traZeneca was able to bring,” Grif­fin said. “By com­bin­ing the two, and then set­ting off to­geth­er to try to dis­cov­er tar­gets and drugs, that was the phi­los­o­phy be­hind start­ing the col­lab­o­ra­tion, and it’s very much felt like that all the way through.

In ad­di­tion to CKD, Benev­o­len­tAI and As­traZeneca are work­ing on de­vel­op­ing drugs for id­io­path­ic pul­monary fi­bro­sis as part of their col­lab­o­ra­tion.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Who’s spend­ing and who’s cut­ting from Big Phar­ma’s $127B R&D bud­get? Here are the top 15 play­ers

A couple of the Big 15 biopharma companies in R&D hit the gas on research spending last year. Merck and Sanofi still have lots to prove in the pipeline, and they’re willing to gamble large sums to make a better future for themselves.

Doing nothing would be infinitely worse.

But collectively, the top players rang up a modest 2.4% increase in spending in 2022, which didn’t cover inflationary pressures. And that set the tone for an extraordinarily cautious year for the industry — even as it laid out about $127 billion to advance new drugs or up the ante on approved therapies.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Van­da wins court case against FDA over dis­clo­sure of CRL de­tails for sleep drug

DC District Court Judge Christopher Cooper today granted Vanda Pharma’s request to require the FDA to disclose more info on the complete response letter for its sleep disorder drug Hetlioz.

The melatonin receptor agonist is approved by the FDA to treat non-24-hour sleep-wake disorder, a circadian rhythm disorder. But in 2018 Vanda filed a supplemental application to market Hetlioz as a treatment for jet lag, which the FDA rejected in August 2019, with few details on what Vanda needed to correct course, according to the company.

Gun­ning for 2023 ap­proval, GSK de­tails PhI­II da­ta for Jem­per­li in front­line en­dome­tri­al can­cer

GSK has a new slate of data to offer on its PD-1 inhibitor, Jemperli — data that the pharma giant hopes will cement one of the four drug approvals it’s expecting this year.

While Jemperli (dostarlimab) is already approved for a subset of patients with second-line endometrial cancer, GSK set out in the Phase III RUBY trial to test it as an earlier line of treatment while also enrolling a broader group of patients. In an interim analysis, Jemperli was shown to extend progression-free survival for both the subset and the overall trial population when added to chemotherapy.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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Max Colao, OncoVerity CEO

Tiny mul­ti­omics biotech se­cures for­mer J&J drug, new ex­ecs and new fi­nanc­ing

A new spinout from Belgium’s argenx seeks to give new life to a candidate once in-licensed to J&J.

OncoVerity announced Monday afternoon that it had in-licensed cusatuzumab from argenx. The biotech also appointed two new C-suite executives and secured a $30 million Series A round.

CEO Max Colao joins OncoVerity after working as Aurinia’s commercial chief, and stints at Alexion and Amgen. New CMO Clay Smith has been associate chief of the University of Colorado’s hematology division.

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Sharon Mates, Intra-Cellular Therapies CEO

In­tra-Cel­lu­lar Ther­a­pies gets a boost on PhI­II de­pres­sion drug da­ta

Biotech Intra-Cellular Therapies touting new data Tuesday for its drug designed to treat major depressive disorder.

The biotech shared results from its Study 403 investigating lumateperone, or Caplyta, as a monotherapy to treat major depressive episodes. The study looked at major depressive disorder (MDD) and bipolar depression with “mixed features.” The trial had three populations: participants with both MDD and bipolar depression, patients with only MDD and patients with only bipolar depression.

Brian Lian, Viking Therapeutics CEO

Viking soars on ear­ly-stage weight loss da­ta as it maps out PhII

Viking Therapeutics will enter the next phase of the GLP-1 weight loss race, as the small biotech touted early data showing its investigational drug led to a drop of as much as 6% more body weight than a placebo.

With research still in the beginning stages of human testing, Viking’s drug will require more fleshed-out data in a Phase II clinical trial, which the San Diego biotech said will start in the middle of this year. Viking hopes the data will help carve a slice of a market dominated by Novo Nordisk and Eli Lilly, with Amgen on their heels and Altimmune trying to push forward despite displeasing investors last week. The companies are developing drugs that have caused a frenzy on social media, in Hollywood and in broader conversations about weight loss drugs and their place in society.