The sec­ond, first AI de­vel­oped drug en­ters the clin­ic; Aprea gets break­through sta­tus for myelodys­plas­tic syn­dromes drug

Sum­it­o­mo Dainip­pon Phar­ma and the UK-based AI start­up Ex­sci­en­tia are claim­ing to have brought the first AI-de­signed drug in­to the clin­ic. The two com­pa­nies say they de­vel­oped the mol­e­cule in less than 12 months, as Ex­sci­en­tia’s AI rapid­ly gen­er­at­ed and sift­ed through mil­lions of po­ten­tial com­pounds to iden­ti­fy ones that would fit Sum­i­mo­to’s tar­get, a re­cep­tor in the brain as­so­ci­at­ed with OCD.

The pair are not the first to make such a claim. Re­cur­sion Bio billed it­self as the first AI com­pa­ny to en­ter hu­man tri­als in Ju­ly, al­though crit­ics point­ed out – and Re­cur­sion CEO Chris Gib­son read­i­ly con­ced­ed — that one of the drugs orig­i­nal­ly came out of the lab of co-founder Dean Li, now head of trans­la­tion­al re­search at Mer­ck. Paul Work­man, CEO of the UK’s In­sti­tute of Can­cer Re­search ap­peared to al­lude to Gib­son and this cri­tique in a quote he pro­vid­ed to Ex­sci­en­tia’s press team to dis­trib­ute to the me­dia: “This is very dif­fer­ent from the use of AI to re­pur­pose drugs,” he said.

Ex­sci­en­tia and Sum­i­mo­to’s drug, though, is not en­tire­ly AI de­vel­oped, ei­ther. They syn­the­sized 350 com­pounds and test­ed them in a lab be­fore de­cid­ing on one to move for­ward. Re­cur­sion’s team, mean­while, came up with its drug can­di­dates by tak­ing com­pounds and putting them in hu­man cells that sim­u­lat­ed dif­fer­ent dis­eases. They then used their AI sys­tem to take mil­lions of pic­tures and an­a­lyze how those drugs were af­fect­ing the cells.

The point isn’t which is “pure AI.” The point is that AI is start­ing to change drug de­vel­op­ment in many ways – Ex­sci­en­tia alone has signed part­ner­ships with Roche, Bay­er, Cel­gene, Sanofi, and GSK – but it’s still ear­ly. Biotech and big phar­ma are still fig­ur­ing it out – and a lot of com­pa­nies are try­ing to ride the buzz while they do.

→ Boston-based Aprea Ther­a­peu­tics now has break­through ther­a­py des­ig­na­tion for APR-246, their lead mol­e­cule tar­get­ing restora­tion of p53, as a treat­ment of myelodys­plas­tic syn­dromes with a sus­cep­ti­ble TP53 mu­ta­tion in com­bi­na­tion with azac­i­ti­dine. The FDA grant­ed the sta­tus just as Aprea is push­ing through a Phase III.

→ Eu­ro­pean pri­vate eq­ui­ty firm Glob­al Health­care Op­por­tu­ni­ties has in­vest­ed in Fair­Jour­ney Bi­o­log­ics, a Por­tuguese biotech that spe­cial­izes in dis­cov­er­ing and de­vel­op­ing an­ti­bod­ies. The com­pa­ny says it has a li­brary of over 10 bil­lion hu­man an­ti­bod­ies. They al­so have a dis­cov­ery pro­gram for three an­ti­body drugs, in­clud­ing one for breast can­cer.

→Bel­gian I/O play­er iTeos Ther­a­peu­tics has bagged a to­tal of €15 mil­lion in non-di­lu­tive fund­ing from the Wal­loon Re­gion — ap­proved by Willy Bor­sus, min­is­ter of econ­o­my and re­search. The award will be used to­wards the clin­i­cal de­vel­op­ment of its two pro­pri­etary an­ti-can­cer drug pro­grams, tar­get­ing im­muno­sup­pres­sion.

Bay­er has com­piled the da­ta on its new for­mu­la­tion of ni­fur­timox — a com­mon­ly used old drug for Cha­gas dis­ease — and it’s sent the ap­pli­ca­tion off to the FDA. The ther­a­py is tai­lored to new­borns, in­fants and chil­dren, whom the com­pa­ny calls “the most vul­ner­a­ble pa­tient group suf­fer­ing from” the ail­ment.

Cor­rec­tion: An ear­li­er ver­sion of this ar­ti­cle in­cor­rect­ly stat­ed the source of a Re­cur­sion drug. 

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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