For­get Bris­tol-My­ers: Re­gen­eron takes on Mer­ck for the heavy­weight ti­tle in non-small cell lung can­cer

Re­gen­eron may have been the 6th bio­phar­ma com­pa­ny to land an ini­tial ap­proval for a PD-1/L1 ther­a­py, but they’re clear­ly not set­tling for any­thing close to a last-place fin­ish in the amaz­ing race for mar­ket dom­i­nance in the mega-block­buster field.

In their Q4 call with an­a­lysts on Thurs­day, Re­gen­eron’s not-shy R&D chief George Yan­copou­los tout­ed their cap­ture of the lead role among check­points in treat­ing ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma. In an in­ter­view with End­points News last month, Yan­copou­los made so se­cret of his opin­ions about the PD-L1s on the mar­ket, slam­ming them all as sec­ond-rate and as­sign­ing worst-in-class sta­tus to Baven­cio from Pfiz­er and Mer­ck KGaA. But they’re al­so mov­ing to chal­lenge gi­ant Mer­ck’s Keytru­da — an­oth­er PD-1 — on one of its ma­jor achieve­ments: win­ning an OK as a monother­a­py for front­line use in non-small cell lung can­cer.

Here’s Yan­copou­los from the call on his I/O strat­e­gy:

(W)e have dou­bled the size of our tri­al com­par­ing Lib­tayo monother­a­py to chemother­a­py in PD-L1-high pa­tients. Re­gard­ing com­bi­na­tions, we’ll be fo­cus­ing our ef­forts in first-line treat­ing and com­bi­na­tion ther­a­py of Lib­tayo with chemother­a­py. The on­go­ing Phase III com­bi­na­tion study is be­ing aug­ment­ed to en­roll non-small cell lung can­cer pa­tients ir­re­spec­tive of his­tol­ogy and the lev­els of PD-L1 ex­pres­sion and to ran­dom­ize to Lib­tayo plus chemother­a­py or chemother­a­py alone.

Amaz­ing­ly enough de­spite the years of ef­fort in many piv­otal tri­als there’s on­ly one PD-1 or PD-L1 an­ti­body ap­proved as monother­a­py in first-line metasta­t­ic non-small cell lung can­cer (Keytru­da). If our on­go­ing tri­als suc­ceed, we have the po­ten­tial to be the sec­ond.

Bris­tol-My­ers Squibb — which so far has pro­vid­ed Keytru­da its biggest chal­lenge with Op­di­vo — has been work­ing hard to over­come Mer­ck’s move to the top of the mar­ket, fo­cus­ing on a tu­mor mu­ta­tion­al bur­den ap­proach that has failed to gain much trac­tion.

Yan­copou­los was al­so quick to tout Re­gen­eron’s bis­pe­cif­ic strat­e­gy, fo­cus­ing on: “the CD3 bis­pecifics and the cos­tim­u­la­to­ry bis­pecifics. We be­lieve that these bis­pecifics may have im­por­tant an­ti­cancer ac­tiv­i­ty on their own and in com­bi­na­tions that can in­clude Lib­tayo.… Many of our CD3 bis­pecifics are al­ready in the clin­ic with one of them show­ing im­pres­sive ini­tial re­sults as a monother­a­py in very-ad­vanced late-stage pa­tients.”

“REGN1979 our CD20xCD3 bis­pe­cif­ic for B-cell Non-Hodgkin’s Lym­phoma or NHL” has achieved im­pres­sive re­sults, he not­ed, adding:

(O)ur BC­MAx­CD3 bis­pe­cif­ic an­ti­body has just en­tered clin­i­cal de­vel­op­ment for the treat­ment of mul­ti­ple myelo­ma. We’re en­cour­aged by pre­lim­i­nary re­sults of both CAR-T as well as BiTEs tar­get­ing BC­MA in mul­ti­ple myelo­ma and be­lieve that our BC­MAx­CD3 bis­pe­cif­ic has a po­ten­tial of be­ing an im­por­tant ad­di­tion in this new area.

“It’s us against the world,” Yan­copou­los told me in a meet­ing at JP Mor­gan. And the Re­gen­eron re­search chief gives the com­pa­ny good odds at win­ning, cit­ing his clear be­lief that the com­pa­ny has the best tech­nol­o­gy and drugs in hand to slam dunk the com­pe­ti­tion.


Im­age: George Yan­copou­los. GET­TY IM­AGES

Eli Casdin, Casdin Capital

Eli Cas­din backs Codex­is' plat­form tech with $50M eq­ui­ty buy

About a month af­ter Codex­is notched a deal with No­var­tis $NVS, the Cal­i­for­nia com­pa­ny $CDXS on Thurs­day said long-time in­vestor Cas­din Cap­i­tal is putting up $50 mil­lion in a pri­vate place­ment, which puts the New York-based in­vest­ment firm in con­trol of more than 5% of the pro­tein en­gi­neer­ing play­er’s stock.

Eli Cas­din start­ed his epony­mous in­vest­ment firm in 2012 and dates his re­la­tion­ship with Codex­is back to at least a decade. About three years ago, Cas­din Cap­i­tal be­gan in­vest­ing in the in­dus­tri­al biotech com­pa­ny, af­ter it piv­ot­ed its fo­cus to the life sci­ences — un­der the aus­pices of new chief John Nicols — away from the en­er­gy in­dus­try.

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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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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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.

In­vestors pony up $476M for the lat­est round of biotech IPOs to hit the Street

Three biotechs — and a genome se­quenc­ing play­er — have caught the lat­est tide to the Gold Coast of IPOs, round­ing out the first half of 2019 with 23 new drug de­vel­op­ers mak­ing it on Nas­daq.

Most of these com­pa­nies filed their IPOs al­most si­mul­ta­ne­ous­ly, though we’re still wait­ing on word of fel­low class­mate Bridge­Bio’s pric­ing af­ter CEO Neil Ku­mar set the terms at $14 to $16 a share on Mon­day in search of a $240 mil­lion (or so) wind­fall. If he’s suc­cess­ful, that would take the one-week haul past the $700 mil­lion mark, a fresh sign that in­vestors’ en­thu­si­asm for new­ly coined pub­lic biotechs hasn’t cooled.

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.

Robert Forrester, Verastem

Ve­rastem CEO For­rester steps to the ex­it as the board hunts com­mer­cial-savvy ex­ec for the be­lea­guered biotech

Robert For­rester is step­ping down as CEO of Ve­rastem On­col­o­gy $VSTM just 8 months af­ter the com­pa­ny nabbed an ap­proval for du­velis­ib, a PI3K drug with a sto­ried past — and what ap­pears as not much of a fu­ture.

The biotech put out word this morn­ing that For­rester will take an ad­vi­so­ry role with Ve­rastem while COO Dan Pa­ter­son steps up to take charge of the lead­er­ship team and the board looks around for a new CEO.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.