Affini­vax, Astel­las be­gin clin­i­cal quest to beat Pfiz­er's Go­liath with a new kind of pneu­mo­coc­cal vac­cine

Days af­ter the FDA blessed Mer­ck’s ef­fort to chal­lenge Pfiz­er’s mega-block­buster Pre­vnar 13 with a break­through des­ig­na­tion, Affini­vax is mak­ing the leap in­to the clin­ic with its own take on the pneu­mo­coc­cal vac­cine.

It’s no small feat for a biotech play­er that got start­ed with $4 mil­lion in seed fund­ing from the Gates Foun­da­tion in 2014 and has been run­ning pure­ly on grants as well as part­ner­ship dol­lars from Astel­las — which is shoul­der­ing much of clin­i­cal work in the Phase I/II study.

“We’ve done in less than five years at Affini­vax what the big vac­cine play­ers like Mer­ck and Pfiz­er and Sanofi and GSK have been try­ing to do for over 20 years,” CEO Steve Brug­ger tells me. “We have ac­tu­al­ly de­vel­oped a true next gen­er­a­tion tech­nol­o­gy for vac­cines.”

Rick Mal­ley

Hav­ing spent the past few years in­dus­tri­al­iz­ing the tech­nol­o­gy that came out of Rick Mal­ley’s lab at Boston Chil­dren’s Hos­pi­tal, Brug­ger and his crew of 68 are con­fi­dent that its prod­uct, ASP3772, can pro­vide “broad­er pro­tec­tion than any vac­cine in the mar­ket or any vac­cine that we’re aware of in clin­i­cal test­ing to­day.”

The spe­cif­ic num­ber of serotypes it will cov­er, though, will be kept se­cret for a lit­tle longer.

Dubbed the mul­ti­ple anti­gen pre­sent­ing sys­tem, or MAPS, Affini­vax’s tech plat­form fore­goes tra­di­tion­al con­ju­gate chem­istry al­to­geth­er in fa­vor of a bi­otin-rhiza­vidin bond, thus re­duc­ing cross-link­ing be­tween pro­teins and poly­sac­cha­rides. More im­por­tant­ly, the pro­teins — mere car­ri­ers in tra­di­tion­al vac­cines — are de­signed to elic­it B and T cell re­spons­es along­side the poly­sac­cha­rides they are bound to.

It’s an ap­proach that’s sup­posed to sep­a­rate Affini­vax from both the big guys and small­er chal­lengers like SutroVax, which has $170 mil­lion to push its own first-in-class con­ju­gate vac­cine to the clin­ic.

That will all be put to the test in the 618-pa­tient tri­al, as ASP3772 gets ad­min­is­tered to both adults and el­der­ly, and com­pared against Pre­vnar 13 as well as Pneu­movax.

Mean­while, the launch of the tri­al has trig­gered a mile­stone pay­ment from Astel­las — $10 mil­lion in cash that will fund Affini­vax’s oth­er bac­te­r­i­al vac­cine projects and some ear­ly, ex­plorato­ry work on im­muno-on­col­o­gy, where the abil­i­ty to present mul­ti­ple im­mune-re­sponse in­duc­ing anti­gens seems to hold promise.

“We stayed home for the first four years and fo­cused on let’s get the lead flag­ship pro­gram in­to the clin­ic, let’s val­i­date the tech­nol­o­gy clin­i­cal­ly, which we’re on track to do,” Brug­ger says. “Now as we look at be­gin­ning of 2019, where else can we ap­ply this tech­nol­o­gy?”

Im­age: Steve Brug­ger.

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.”