As ri­vals press in, Stan­ford spin­out Forty Sev­en bur­nish­es its prospects from an im­pres­sive PhIb

Irv Weiss­man’s an­ti-CD47 can­cer drug is in the spot­light to­day with ear­ly but re­mark­able da­ta pub­lished in the NE­JM to un­der­score its po­ten­tial as a new can­cer ther­a­py.

Irv Weiss­man

The leg­endary Stan­ford in­ves­ti­ga­tor found­ed Forty Sev­en $FTSV to see if it could take the lead among biotechs work­ing on con­quer­ing the ‘don’t-eat-me’ sig­nal emit­ted by the pro­tein CD47 on can­cer cells. Com­bined with rit­ux­imab, their com­bo elicit­ed a pos­i­tive re­sponse in half of the can­cer pa­tients they test­ed it on, with 8 of those pa­tients achiev­ing a com­plete re­sponse — with no sign of resid­ual dis­ease.

Three pa­tients did not re­spond and died. All of the pa­tients had failed at least 2 lines of ther­a­py — with a me­di­an of 4 fail­ures — be­fore they were re­cruit­ed for the tri­al. This is an up­date on their first da­ta cut at AS­CO.

Their an­ti­body — Hu5F9-G4, of 5F9  — is de­signed to spur macrophages to slaugh­ter can­cer cells. And in this study re­searchers re­cruit­ed a hand­ful of peo­ple with two kinds of non-Hodgkin’s lym­phoma: dif­fuse large B-cell lym­phoma and fol­lic­u­lar lym­phoma.

“It’s very ex­cit­ing to have a po­ten­tial­ly new class of im­munother­a­py like this,” said Stan­ford pro­fes­sor Ran­jana Ad­vani, who led the Phase Ib tri­al. “For the first time we have an an­ti­body that ac­ti­vates macrophages against can­cer and ap­pears to be safe for use in hu­mans.”

Forty Sev­en has an in­ter­est­ing past. The 78-year-old Weiss­man was able to wran­gle sub­stan­tial sup­port for his ear­ly re­search work on CD47 from the Cal­i­for­nia In­sti­tute for Re­gen­er­a­tive Med­i­cine, even launch­ing ear­ly hu­man stud­ies — a rare feat in aca­d­e­m­ic cir­cles. Weiss­man and for­mer CIRM chief Alan Troun­son en­joyed a tight re­la­tion­ship, which ex­tend­ed to Troun­son’s ap­point­ment to the board of an­oth­er start­up that Weiss­man had helped found — Stem­Cells — short­ly af­ter his de­par­ture from the agency. And Forty Sev­en is still get­ting mon­ey from CIRM un­der its lat­est $19 mil­lion grant.

The com­pa­ny isn’t alone in this field, with sev­er­al ri­vals look­ing to pi­o­neer new drugs. Po­ten­tial com­peti­tors in­clude Arch On­col­o­gy (for­mer­ly Tioma Ther­a­peu­tics), backed by No­vo, GSK and Roche; Sur­face On­col­o­gy as well as Boehringer In­gel­heim, among oth­ers.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

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Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million Series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017. Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.