8 stars: A look back at AS­CO spot­lights the top can­cer drugs to watch, and 1 to for­get

I’ve been mak­ing the trek to AS­CO for some years now, and I don’t re­call any oth­er week that ri­vals what I’ve just seen. There wasn’t just im­por­tant da­ta to re­port on, there was a lot of it.

CAR-T, with all of its splen­did ini­tial promise in liq­uid tu­mors, is reach­ing the first ma­jor com­mer­cial fin­ish line, with No­var­tis’ $NVS CTL019 out in front of Kite’s $KITE KTE-C19 by a nose. No­var­tis wait­ed to cap­ture the in­dus­try’s at­ten­tion at an­oth­er con­fer­ence mid-week with head-to-head da­ta, but you bet­ter be­lieve it fig­ured promi­nent­ly on my AS­CO in­ter­view sched­ule.

Juno $JUNO, knocked out of the first race, is mak­ing a strong come­back bid with JCAR017, which will like­ly fig­ure promi­nent­ly in the sec­ond wave ther­a­pies to get a close ex­am­i­na­tion in a piv­otal tri­al.

But what about BC­MA? Blue­bird $BLUE tru­ly wowed the field with da­ta from its close­ly-watched Cel­gene-part­nered pro­gram for bb2121 in treat­ing mul­ti­ple myelo­ma. But in this field the po­ten­tial for sur­prise un­der­lies every twist and turn of the im­muno-on­col­o­gy field. And so we find an ob­scure Chi­nese com­pa­ny called Nan­jing Leg­end — “great name, isn’t it?” said chief blue­bird Nick Leschly with a smile as we com­pared BC­MA da­ta — get­ting shoved in­to AS­CO’s mar­quee cir­cle with even bet­ter da­ta from a larg­er group.

So now we have a new drug to track.

I’ll ad­mit, Loxo ex­ecs have a weary­ing habit of tout­ing every tiny bit of new da­ta on pos­i­tive out­comes, but it $LOXO too is look­ing to make can­cer drug his­to­ry by go­ing af­ter a dual adult/pe­di­atric ap­proval based on a bio­mark­er, fol­low­ing close­ly on a ge­net­ic break­through by Mer­ck $MRK.

One sto­ry that didn’t get much trac­tion over­all, but should have, be­longed to Re­gen­eron $REGN and its Big Phar­ma part­ner Sanofi, which are mov­ing ahead with a next-gen PD-1 check­point, REGN2810. Re­gen­eron has one of the best an­ti­body de­vel­op­ment shops in the world. And if its re­searchers are right, they’ve gleaned new in­sights on the field that could have a pro­found af­fect on how these drugs are made and used. If you missed it, I’d en­cour­age you to go back for an­oth­er look.

In­cyte’s new up­dat­ed da­ta $IN­CY on epaca­dos­tat were al­so gone over with a fine tooth comb. There have been some re­cent jit­ters in the IDO1 field, but In­cyte re­mains out front as the big PD-(L)1 Phase III tri­als with Mer­ck and Bris­tol-My­ers Squibb get un­der­way.

There have been a few IDO jit­ters ev­i­dent, though, es­pe­cial­ly af­ter Roche’s team held their noses while dis­cussing their IDO1 da­ta for GDC-0919 (navox­i­mod), in-li­censed from NewLink for $150 mil­lion up front.

In­de­pen­dent can­cer drug in­vestor Brad Lon­car was on hand for the Roche pre­sen­ta­tion at AS­CO, and not­ed a de­tectable sound of skep­ti­cism.

A few days lat­er, Roche’s Genen­tech kicked it out of the pipeline. For NewLink $NLNK, which has ex­pe­ri­enced a string of pun­ish­ing set­backs, it was an­oth­er cau­tion­ary tale to re­mind ob­servers that not every­one is suc­ceed­ing in the boom­ing on­col­o­gy busi­ness. But the stand­outs mark po­ten­tial­ly new stan­dards of ther­a­py in on­col­o­gy. And the progress is gath­er­ing speed.

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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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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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

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.