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.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.

UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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