Can­cer drug ri­vals at Loxo and Blue­print go toe-to-toe once again, and one an­a­lyst scores a (pos­si­ble) win on points

Who’s ready to start the week com­par­ing da­ta on two ri­val can­cer drugs from stud­ies fea­tur­ing dif­fer­ent tri­al de­signs?

OK, I’ll do it any­way.

Loxo On­col­o­gy $LOXO and Blue­print Med­i­cines $BPMC have been duk­ing it out with their ear­ly-stage stud­ies on their RET in­hibitors, and they were both back at it with up­dates for mu­tant medullary thy­roid can­cer at the Amer­i­can Thy­roid As­so­ci­a­tion meet­ing over the week­end.

An­drew Berens

Leerink’s An­drew Berens scored the two lat­est snap­shots on da­ta, and I’ll let him do the sum­ma­ry. First, though, I’ll echo Berens’ note that the two drugs are not dosed the same way, with Loxo pa­tients able to get a dose es­ca­la­tion dur­ing the study, while Blue­print is stick­ing with a fixed-dose study — which may put it at a dis­ad­van­tage in terms of quick com­par­isons.

Purists in the field hate these tri­al com­par­isons, but in­vestors eat them up.

That said, Loxo re­port­ed an up­dat­ed ORR of 59% for LOXO-292, with 2 com­plete re­spons­es and 15 par­tials. The ORR is up from the 45% re­port­ed at AS­CO while the 78% re­sponse rate seen for pa­tients with a RET fu­sion thy­roid can­cer is down a bit. Still, the an­a­lyst notes, the up­date on­ly ac­counts for 9 pa­tients in to­tal, so don’t try to read too much in­to that.

Blue­print, which has suf­fered be­fore from the side-by-side pics with BLU-667, had a 49% re­sponse rate with 1 CR and 16 PRs. Berens: “In­ter­est­ing­ly, re­spons­es ap­pear to be deep­en­ing over time. ORR for pa­tients treat­ed at 300/400mg QD dose lev­el was 35% at 8 weeks of treat­ment, 56% at 16 weeks and 62% at 24 weeks. Re­spons­es were equiv­a­lent in pa­tients with and with­out pri­or mul­ti-ki­nase in­hibitor (MKI) treat­ment (~50%). 83% (35/42) of thy­roid can­cer pa­tients re­main on treat­ment, and 100% of re­spon­ders (19/19) and those treat­ed at 400mg QD (14/14) re­main on ther­a­py.”

Sure, says Berens, Blue­print may well feel some heat be­cause its num­bers still don’t mea­sure up to Loxo — now part­nered in a deal with Bay­er — but he gives both drugs a thumbs up for im­prov­ing re­sponse rates and im­pres­sive (ear­ly) signs of dura­bil­i­ty.

Did I say that this ri­val­ry has a ways to run?

For now, the hand­i­cap­ping con­tin­ues to fa­vor Loxo, but this race isn’t over. Al­so, there’s noth­ing in the Blue­print num­bers to sug­gest that they’re go­ing to be forced out of the race, with good chances that both get through a well greased reg­u­la­to­ry sys­tem — pro­vid­ed the da­ta hold up.

Loxo al­so got bonus points at the ATA meet­ing. Berens notes that they have “up­dat­ed da­ta for larotrec­tinib in sev­en pa­tients with TRK fu­sion thy­roid can­cer. Five of these pa­tients had pap­il­lary dis­ease, while one had fol­lic­u­lar, and one had anaplas­tic dis­ease. Six of the sev­en pa­tients re­main on ther­a­py, with du­ra­tion of treat­ment rang­ing from 12.9 months to 28.7 months.”

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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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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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.

In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.

John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Right back at you, Pfiz­er: BeiGene and a Pfiz­er spin­out launch a new­co to de­vel­op a MEK/BRAF in­hibitor that could ri­val $11.4B com­bo

A day af­ter Pfiz­er bought Ar­ray and its ap­proved can­cer com­bo, BeiGene and Pfiz­er spin­out Spring­Works have part­nered in launch­ing a new biotech that has an eye on the very same mar­ket the phar­ma gi­ant just paid bil­lions for. And they’re plan­ning on us­ing an ex-Pfiz­er drug to do it.

In a nut­shell, Chi­na’s BeiGene is toss­ing in a pre­clin­i­cal BRAF in­hibitor — BGB-3245, which cov­ers both V600 and non-V600 BRAF mu­ta­tions — for a big stake in a new, joint­ly con­trolled biotech called Map­Kure with Bain-backed Spring­Works.

Sanofi aligns it­self with Google to stream­line drug de­vel­op­ment

Tech­nol­o­gy is bleed­ing in­to health­care, and big phar­ma is rid­ing the wave. Sanofi $SNY ap­point­ed its first chief dig­i­tal of­fi­cer this Feb­ru­ary, fol­low­ing the foot­steps of its peers. By May, the French drug­mak­er and some of its big phar­ma com­pa­tri­ots joined forces with Google par­ent Al­pha­bet’s Ver­i­ly unit to aug­ment clin­i­cal tri­al re­search. On Tues­day, the Parisian com­pa­ny tied up with Google to ac­cess its cloud com­put­ing and ar­ti­fi­cial in­tel­li­gence tech to spur the de­vel­op­ment of new ther­a­pies.

UP­DAT­ED: Roche fields first ap­proval for Ro­z­lytrek in the run-up to a show­down with Bay­er, Pfiz­er

While it’s wait­ing to hear back from FDA reg­u­la­tors, Roche is be­gin­ning the vic­to­ry lap for en­trec­tinib in Japan.

Roche is giv­ing Bay­er a run for their mon­ey with this tu­mor-ag­nos­tic drug, which tar­gets NTRK gene fu­sions. Now dubbed Ro­z­lytrek, it’s sanc­tioned to treat adult and pe­di­atric pa­tients in Japan with neu­rotroph­ic ty­ro­sine re­cep­tor ki­nase fu­sion-pos­i­tive, ad­vanced re­cur­rent sol­id tu­mors.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”