Daniel O'Day (AP Images)

Amid remde­sivir craze Gilead finds time for an­oth­er on­col­o­gy pact — loop­ing in all things NK cells

Gilead’s $4.9 bil­lion buy­out of Forty Sev­en, an­nounced in ear­ly March, land­ed in a dif­fer­ent era be­fore the pan­dem­ic con­sumed bio­phar­ma news. But even amid all the buzz around its po­ten­tial Covid-19 treat­ment remde­sivir, CEO Daniel O’Day is still mak­ing clear that on­col­o­gy is where he wants to take the com­pa­ny.

His lat­est deal is a re­search col­lab­o­ra­tion in­volv­ing a low-pro­file play­er head­quar­tered in Mel­bourne — so stealthy that the up­front pay­ment and to­tal val­ue are all still un­der wraps. What Gilead did re­veal, how­ev­er, is an in­ter­est in oNKo-in­nate’s ex­per­tise in nat­ur­al killer cells as a new fron­tier of im­muno-on­col­o­gy.

William Lee

“We have a strate­gic fo­cus of grow­ing both our ex­per­tise and pipeline in im­muno-on­col­o­gy and we be­lieve this ex­cit­ing col­lab­o­ra­tion will sup­port each of these ob­jec­tives as we work to dis­cov­er and de­vel­op nov­el can­cer ther­a­pies for pa­tients,” William Lee, Gilead’s EVP of re­search, said in a state­ment.

While T cell me­di­at­ed an­ti-tu­mor ac­tiv­i­ty cur­rent­ly dom­i­nates can­cer im­munother­a­py — from CAR-T to PD-(L)1 in­hi­bi­tion — NK cells, a fel­low mem­ber of the lym­pho­cyte class, al­so plays a sur­veil­lance and ef­fec­tor role.

Mul­ti­ple ap­proach­es have emerged to kick them in­to ac­tion: Af­fimed and Drag­on­fly promise to ac­ti­vate and en­gage what’s al­ready in the body, while oth­ers like Cy­tovia and a Take­da-backed group at MD An­der­son are in­ter­est­ed in at­tach­ing re­cep­tors to de­vel­op a CAR-NK ther­a­py. Among those go­ing the en­gi­neer­ing route, there are yet dif­fer­ent ways to man­u­fac­ture NK cells. J&J re­cent­ly bet on Fate Ther­a­peu­tics’ iP­SC-based ap­proach; Nkar­ta re­lies on healthy donors; while Celar­i­ty ex­tracts them from pla­cen­tas.

oNKo-in­nate, mean­while, says it is “modal­i­ty ag­nos­tic.”

The com­pa­ny’s co-founders Jai Rautela and Nicholas Hunt­ing­ton set out in 2016 to look for the whole range of ways NK cells are in­volved in in­nate tu­mor recog­ni­tion, how they move and per­sist in the body, and are neg­a­tive­ly reg­u­lat­ed.

Over three years, oNKo-in­nate will de­ploy its genome-wide screen­ing tech­niques and im­mune cell tar­get dis­cov­ery plat­form in ser­vice of Gilead’s I/O pro­gram and sub­sidiary Kite Phar­ma’s cell ther­a­py work. The for­mer will like­ly yield tar­gets for an­ti­bod­ies or fu­sion pro­teins — of which there are sev­er­al in Gilead’s ear­ly-stage pipeline — while the goal of the lat­ter is to cre­ate and eval­u­ate NK con­structs.

Jai Rautela and Nicholas Hunt­ing­ton

Click on the im­age to see the full-sized ver­sion

Gilead’s Kite sub­sidiary is run by Christi Shaw — and de­spite a re­cent le­gal set­back, which leaves it on the hook for over a bil­lion dol­lars in IP dam­ages to Juno, the com­pa­ny is hus­tling a sec­ond CAR-T to­ward the FDA and in­tent on de­liv­er­ing more.

On the I/O side, Forty Sev­en marked Gilead’s largest ac­qui­si­tion since they bought Kite for $11.9 bil­lion in 2017, if you leave out the part­ner­ship ex­pan­sion with Gala­pa­gos worth $5 bil­lion. That deal brought in ma­grolimab, a CD47 an­ti­body that came out of Irv Weiss­man and Ravin­dra Ma­jeti’s long­time work on the “don’t eat me” sig­nal. Be­fore that, back in late 2018, Gilead bet $150 mil­lion in cash on Agenus’ plat­form, so far pro­duc­ing one bis­pe­cif­ic mol­e­cule and an­oth­er block­ing CD137.

More deals might yet be on the ta­ble. The lat­est ru­mor cen­ters around Ar­cus, led by biotech vet Ter­ry Rosen and de­vel­op­ing drugs against TIG­IT, CD73 and A2aR/A2bR.

Bot­tom line, as O’Day put it in his first an­a­lyst call of the year: Gilead aims to in­tro­duce 10 new trans­for­ma­tive ther­a­pies in the next 10 years. Bolt-on deals and part­ner­ships will be the way to go.

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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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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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.

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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