PD-L1 check­point play­er Mer­ck KGaA dives in­to next-gen work with F-star col­lab­o­ra­tion

John Hau­rum

CHICA­GO — Not all the biotech news on can­cer drugs this past week­end is di­rect­ly re­lat­ed to the big AS­CO con­fab in Chica­go. Cam­bridge, UK-based F-star para­chut­ed in news of its lat­est tie-up, this one a buy-in from Mer­ck KGaA, which picked up rights to a lead bis­pe­cif­ic check­point drug.

Mer­ck KGaA and its Big Phar­ma part­ner Pfiz­er re­cent­ly hit the mar­ket with one of the first 5 check­points, the PD-L1 drug Baven­cio (avelum­ab). Now it’s look­ing past that ini­tial mar­ket en­try in­to the next-gen ther­a­pies mak­ing their way in­to the clin­ic. And it picked up an op­tion on a pre­clin­i­cal LAG-3, PD-L1 bis­pe­cif­ic at F-star called FS118. In ad­di­tion, Mer­ck KGaA gets an op­tion on 4 oth­er pre­clin­i­cal ther­a­pies — all un­spec­i­fied i/o drugs.

F-Star set up its fourth as­set ve­hi­cle in struc­tur­ing the deal, dubbed F-star Delta. Mer­ck KGaA will pay €115 mil­lion in the first cou­ple of years, a sum bro­ken up for an un­spec­i­fied up­front, R&D pay­ments as well as a pair of ear­ly mile­stones for the first two years. Then Ger­man Mer­ck will have the op­por­tu­ni­ty to de­cide if it wants to ex­er­cise its buy­out op­tion, bit­ing off a sec­ond stage that brings the to­tal to a po­ten­tial $1 bil­lion-plus, says F-star CEO John Hau­rum.

Hau­rum tells me the hy­poth­e­sis that his team is pur­su­ing is that “there will be ben­e­fits in the bis­pe­cif­ic that go be­yond the straight com­bi­na­tion” of two drugs di­rect­ed at each check­point tar­get. LAG-3 is one of a group of check­point tar­gets that has at­tract­ed wide­spread in­ter­est among the bio­phar­ma com­pa­nies go­ing deep­er in­to the field.

Hau­rum notes that there’s lot of work to be done yet, but the bis­pe­cif­ic has the po­ten­tial to de­liv­er more drug in­to the tu­mor tis­sue, of­fer­ing a bet­ter safe­ty pro­file. There could al­so be ad­van­tages in bridg­ing be­tween T cells and the tar­get­ed tu­mor anti­gen.

F-star has three oth­er as­set sub­sidiaries it’s work­ing on, in­clud­ing Gam­ma part­nered with the Bay Area biotech De­nali. Be­ta is an­oth­er i/o deal with Ab­b­Vie while Bris­tol-My­ers Squibb kicked loose its HER-2 pro­gram Al­pha a few weeks ago. The one-time part­ners kept the spe­cif­ic rea­sons for the breakup un­der wraps, but Hau­rum not­ed that the HER-2 field is a crowd­ed one.

F-star has 85 staffers these days, a sig­nif­i­cant work­force in these cir­cles. And Hau­rum says they’re al­so work­ing on pro­pri­etary ther­a­pies as they con­tin­ue to ramp up new part­ner­ships.

Mer­ck KGaA re­cent­ly sold off its biosim­i­lars port­fo­lio, look­ing to fol­low up on its suc­cess in on­col­o­gy.

“Our col­lab­o­ra­tion with Fstar will help us to rapid­ly en­hance our pipeline and grow our port­fo­lio of bis­pe­cif­ic im­munother­a­pies,” not­ed Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti in a pre­pared state­ment.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

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Roger Perlmutter. Merck via webcast

'Our lega­cy mat­ter­s': Mer­ck maps out Keytru­da king­dom while spot­light­ing ad­vances in vac­cines, hos­pi­tal care

“You can for the mo­ment stop tak­ing notes. You can put down your pens and your pad. I have no slides. I have no sub­stan­tive da­ta. I have no pitch.”

So be­gan Roger Perl­mut­ter’s brief ap­pear­ance on­stage at Mer­ck’s first in­vestor day in five years, where he dived in­to the com­pa­ny’s his­to­ry dat­ing back to 1933. The first em­ploy­ees at Mer­ck Re­search Lab­o­ra­to­ries, hand­picked by founder George W. Mer­ck, were crit­i­cal to Mer­ck’s abil­i­ty to achieve clin­i­cal and com­mer­cial suc­cess.

Which top 10 big phar­mas have the most to gain — or lose — over the next 5 years?

When Evaluate Pharma crunched the likely drug sales numbers for the big 10, 2 stood out. 

Takeda, with its big Shire buyout under its belt, is set to almost double its worldwide sales record for 2018 over 5 years, putting it in the big 10 — the 9th spot, to be exact — which is exactly where CEO Christophe Weber wants to be. 

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.

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In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Re­gen­eron/Sanofi's an­ti­body un­der­whelms in asth­ma study — shares of ri­val Anap­tys­Bio pay the price

Al­though ex­pec­ta­tions were mut­ed, Re­gen­eron $REGN and Sanofi’s $SNY ex­per­i­men­tal IL-33 an­ti­body has un­der­whelmed in a proof-of-con­cept mid-stage asth­ma tri­al. Al­though the drug sig­nif­i­cant­ly im­proved the loss of asth­ma con­trol and lung func­tion as a monother­a­py com­pared to a place­bo, its ef­fect was nei­ther su­pe­ri­or to the es­tab­lished Dupix­ent, nor of val­ue when com­bined with the IL-4/IL-13 treat­ment.

Green-light­ed in Japan, FDA quick­ly spurns Dai­ichi Sanky­o's flawed ap­pli­ca­tion for AML drug

Three days af­ter win­ning Japan­ese ap­proval for its acute myeloid leukemia drug quizar­tinib, Dai­ichi Sankyo is be­ing forced to en­dure an em­bar­rass­ing re­jec­tion at the hands of the FDA.

US reg­u­la­tors wast­ed no time in bat­ting back quizar­tinib af­ter first high­light­ing the messy da­ta in its ap­pli­ca­tion in an in­ter­nal re­view, that in turn per­suad­ed a large ma­jor­i­ty of out­side ex­perts to rec­om­mend a re­jec­tion for the drug, which tar­gets FLT3-ITD–pos­i­tive AML cas­es.