Pfiz­er, Mer­ck KGaA run in­to a se­vere set­back as PD-L1 drug Baven­cio fails in PhI­II gas­tric can­cer study

Pfiz­er $PFE and its part­ner Mer­ck KGaA have run in­to a dead end in their race to ex­pand the mar­ket for their PD-L1 check­point Baven­cio (avelum­ab). Re­searchers to­day con­ced­ed that the check­point — one of 5 now scram­bling to ex­pand their mar­ket turf in the mega-block­buster glob­al on­col­o­gy busi­ness — failed to sig­nif­i­cant­ly im­prove over­all sur­vival for ad­vanced gas­tric can­cer pa­tients com­pared to best stan­dard of care.

We won’t see the da­ta un­til a lat­er sci­en­tif­ic con­fer­ence to be de­cid­ed on, but the JAVELIN Gas­tric 300 flop will put a def­i­nite hitch in their plans to ex­pand sales for a key drug in both com­pa­nies’ pipelines.

Lu­ciano Ros­set­ti, Mer­ck KGaA

Mer­ck KGaA R&D chief Lu­ciano Ros­set­ti put the fail­ure down to their de­ci­sion to test the drug against cur­rent­ly used chemo rather than a place­bo. He not­ed:

“Gas­tric can­cer in the third-line set­ting is a par­tic­u­lar­ly hard-to-treat and het­ero­ge­neous dis­ease, and im­por­tant­ly, this was the first tri­al con­duct­ed with a check­point in­hibitor com­pared to an ac­tive chemother­a­py com­para­tor rather than place­bo in a glob­al pa­tient pop­u­la­tion.”

The tri­al en­rolled 371 pa­tients from 147 sites in Asia, Aus­tralia, Eu­rope, North Amer­i­ca and South Amer­i­ca. Gas­tric can­cer counts as the third most com­mon type of can­cer killer.

Their mis­for­tune is US Mer­ck’s gain, as well as Bris­tol-My­ers Squibb’s, which both earned third-line ap­provals af­ter test­ing their drugs against a place­bo.

Mer­ck gained an ac­cel­er­at­ed OK from the FDA two months ago to use Keytru­da, a PD-1 check­point, against ad­vanced gas­tric can­cer af­ter lay­ing out mar­gin­al­ly suc­cess­ful re­sponse rates for pa­tients whose tu­mors hit the mark on PD-L1 ex­pres­sion. And af­ter look­ing over the da­ta on over­all sur­vival for both ap­proved ther­a­pies, Uber Raf­fat at Ever­core ISI con­clud­ed that Pfiz­er and Mer­ck KGaA faced tough odds from the start.

And the fail­ure rais­es an­oth­er is­sue, he says:

Im­me­di­ate­ly makes you won­der: is avelum­ab in­fe­ri­or on ef­fi­ca­cy?  And does this tie in­to the broad­er PDL1 vs PD1 de­bate?

That de­bate cen­ters on a heat­ed dis­cus­sion of whether PD-L1 is in­her­ent­ly weak­er than PD-1, so you can ex­pect to hear lots more about it.

This set­back for Pfiz­er and Mer­ck KGaA al­so un­der­scores the se­ries of stun­ning sur­pris­es that con­tin­ues to ad­vance some play­ers while oth­ers are held back. Check­points, which re­moves a brake on an im­mune sys­tem re­sponse to can­cer cells, are fast en­ter­ing the stan­dard of care in a wide range of on­col­o­gy mar­kets, both as a so­lo ther­a­py as well as in com­bi­na­tion. And there’s been a fren­zied race to field new check­points, as we high­light in this re­cent piece not­ing 50 PD-1/L1 ther­a­pies in the clin­ic and 114 more in pre­clin­i­cal de­vel­op­ment.

Still in the pipeline is a Phase III study — JAVELIN Gas­tric 100 — which is test­ing the check­point as a front­line ther­a­py for gas­tric can­cer.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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