As­traZeneca com­mits $57.5M to seed An­ti­calin R&D pact with Pieris, a biotech on a roll

Stephen Yo­der

Boston-based Pieris Phar­ma­ceu­ti­cals has rolled out its sec­ond big-mon­ey col­lab­o­ra­tion in the last four months, this time reel­ing in Big Phar­ma play­er As­traZeneca, which wants to see just how ef­fec­tive the biotech’s pro­tein en­gi­neer­ing work can be in treat­ing res­pi­ra­to­ry dis­eases.

Pieris $PIRS has been work­ing for years on en­gi­neer­ing pro­teins that are lighter and more ver­sa­tile than an­ti­bod­ies, so that they can work where an­ti­bod­ies find their en­try barred.

So now Pieris is charged with tak­ing their lead res­pi­ra­to­ry drug — PRS-060, an An­ti­calin against in­ter­leukin-4 re­cep­tor al­pha — in­to a Phase I asth­ma tri­al. Once they do that, they can score $12.5 mil­lion to add to the $45 mil­lion up­front they are get­ting in the pact.

Af­ter that, there’s a load of biobucks on the ta­ble to­tal­ing $2.1 bil­lion for mile­stones plus roy­al­ties. Pieris has the right to grab co-de­vel­op­ment and co-com­mer­cial­iza­tion rights on the lead pro­gram af­ter Phase IIa, and then As­traZeneca has rights to de­vel­op four more of these res­pi­ra­to­ry An­ti­calins, with Pieris able to part­ner on two of these ther­a­pies.

In­vestors loved what they were see­ing this morn­ing, ig­nit­ing Pieris stock, which soared 52%.

This is an­oth­er key deal for Pieris, which struck a pact with Servi­er last Jan­u­ary worth $31.5 mil­lion up­front and $1.8 bil­lion in mile­stones for a next-gen, bis­pe­cif­ic PD-1 drug PRS-332 and four more im­muno-on­col­o­gy pro­grams. Pieris ear­li­er struck a pact to work with Roche.

“While of course this adds cash run­way to bridge through yet ad­di­tion­al clin­i­cal in­flec­tion points, what we’re most ex­cit­ed about is that it will al­low us to more ag­gres­sive­ly fol­low clin­i­cal da­ta we hope to emerge from our IO pipeline, par­tic­u­lar­ly our 4-1BB bis­pe­cif­ic, PRS-343, while not hav­ing to in­ap­pro­pri­ate­ly di­lute our share­hold­ers,” Pieris CEO Steve Yo­der told me in an email. “And the fact that we’re able to have done this with­out part­ing with any rights to PRS-343 all while re­tain­ing co-dev and com­mer­cial rights for our lead res­pi­ra­to­ry as­set, PRS-060, is par­tic­u­lar­ly ex­cit­ing.”

As­traZeneca clear­ly has to be en­thused about this one. The phar­ma gi­ant has been de­vot­ing re­sources for its on­col­o­gy pipeline, re­cent­ly win­ning an ap­proval for its check­point dur­val­um­ab and keep­ing its fin­gers crossed that a com­bo of dur­val­um­ab and treme­li­mum­ab works in front­line lung can­cer.

The big idea here is that the An­ti­calins that Pieris is work­ing on can hit two key cy­tokines — IL-4 and IL-13 — in­volved in asth­ma. And by pen­e­trat­ing in­to the lungs, they be­lieve they can do it with a lighter, safer, more tol­er­a­ble dose.

Out­side of on­col­o­gy, the phar­ma gi­ant has been out­li­cens­ing more than it’s been in-li­cens­ing, gen­er­at­ing rev­enue out of less com­pelling as­sets as it seeks a fun­da­men­tal turn­around af­ter see­ing gener­ics dec­i­mate its biggest fran­chis­es.

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:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

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.
Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

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.

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,000+ biopharma pros reading Endpoints daily — and it's free.

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.

Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.