Can dif­fer­ences in ge­nom­ic im­mune sys­tem sig­na­tures de­tect lung can­cer be­fore it takes hold?

There’s as­pirin for col­orec­tal can­cer and statins for car­dio­vas­cu­lar dis­ease, but for the lead­ing cause of can­cer deaths glob­al­ly — lung can­cer — there’s no tool in the doc­tor’s ar­se­nal to ar­rest or pre­vent the fa­tal dis­ease (apart from smok­ing ab­sti­nence). But a new study sug­gests ge­nom­ic im­mune sys­tem dis­par­i­ties may play a cru­cial role in the de­vel­op­ment of lung can­cer, set­ting the stage for fresh ther­a­peu­tics that could arm the im­mune sys­tem to bet­ter fight can­cer­ous cells from an­chor­ing in the lungs.

Killing rough­ly 160,000 Amer­i­cans an­nu­al­ly, lung can­cer has a high­er death toll than col­orec­tal, pan­cre­at­ic, breast, and prostate can­cer com­bined. This is part­ly due to the fact that it is typ­i­cal­ly on­ly de­tect­ed in its lat­er stages, which makes treat­ment dif­fi­cult and puts a cure out of con­tention.

Al­though lung can­cer can oc­cur in non-smok­ers — ex­po­sure to cig­a­rette smoke cre­ates a field of in­jury through­out the en­tire res­pi­ra­to­ry tract by in­duc­ing a va­ri­ety of ge­nom­ic al­ter­ations that can lead to an at-risk air­way where pre­ma­lig­nant le­sions (PMLs) and lung can­cers de­vel­op. So re­searchers from Boston Uni­ver­si­ty School of Med­i­cine; Uni­ver­si­ty of Cal­i­for­nia, Los An­ge­les; the Roswell Park Com­pre­hen­sive Can­cer Cen­ter and J&J’s Janssen unit con­duct­ed a study, eval­u­at­ing, via biop­sies, for­mer and cur­rent cig­a­rette smok­ers that pre­sent­ed these ear­ly pre-can­cer­ous le­sions in the air­way and lungs over sev­er­al years to check whether their le­sions pro­gressed to­ward lung can­cer.

Their study, pub­lished in Na­ture Com­mu­ni­ca­tions on Tues­day, found bi­o­log­i­cal char­ac­ter­is­tics with­in the le­sions that in­di­cat­ed a high­er risk of pro­gress­ing to lung can­cer, and that the pro­gres­sive le­sions had a pauci­ty of im­mune cells.

“(I)t shows that the pres­ence or ab­sence of im­mune cells in lung pre-can­cer­ous le­sions may pro­vide crit­i­cal in­for­ma­tion as to whether that le­sion will progress to­wards in­va­sive lung can­cer,” said Avrum Spi­ra, who serves as glob­al head of J&J’s Lung Can­cer Ini­tia­tive and Alexan­der Gra­ham Bell pro­fes­sor at Boston Uni­ver­si­ty, in a state­ment. “This in­for­ma­tion could one day un­der­pin strate­gies to iden­ti­fy in­di­vid­u­als who are in­cu­bat­ing lung can­cer and in­ter­cept the de­vel­op­ment of man­i­fest­ed in­va­sive dis­ease.”

Avrum Spi­ra

In ad­di­tion, the study in­di­cat­ed that changes in ag­gres­sive pre-can­cer­ous le­sions could be di­ag­nosed by em­ploy­ing a flex­i­ble brush to amass cells from the air­way through the catheter of a bron­cho­scope, ver­sus the tra­di­tion­al­ly in­va­sive lung or air­way biop­sy. This could cul­mi­nate in the de­vel­op­ment of di­ag­nos­tics for ear­ly-stage dis­ease and iden­ti­fy pa­tients who could ben­e­fit from med­ical in­ter­ven­tion.

J&J has been tak­ing steps to ex­pand its of­fer­ings to man­age lung can­cer — one of the most lu­cra­tive phar­ma­ceu­ti­cal fields — from di­ag­no­sis to in­ter­ven­tion. In Feb­ru­ary, the US drug­mak­er agreed to a $3.4 bil­lion deal to buy Au­ris Health, a pri­vate­ly held de­vel­op­er of ro­bot­ic tools for lung can­cer to beef up its ar­se­nal of sur­gi­cal, in­ter­ven­tion­al and di­ag­nos­tic prod­ucts.

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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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.

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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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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