Mer­ck’s glo­ri­ous vic­to­ry in lung can­cer marks a Russ­ian win­ter for Bris­tol-My­ers

Sun­day was check­point in­hibitor day at ES­MO, with the three big play­ers now in the mar­ket out­lin­ing how they’re lin­ing up in the block­buster field of lung can­cer ther­a­py. Mer­ck was left in the en­vi­able po­si­tion of dri­ving home some im­pres­sive re­sults from its clin­i­cal study while Bris­tol-My­ers Squibb had to try to put its mis­er­able out­comes in a some­what pos­i­tive con­text and a de­ter­mined Roche/Genen­tech team an­gled in on its niche.

As­traZeneca CEO Pas­cal So­ri­ot, mean­while, had to stand on the side­lines de­vout­ly wish­ing he was in the game of block­busters.

Bris­tol-My­ers Squibb $BMY made a Napoleon­ic mis­cal­cu­la­tion when it de­cid­ed to see if Op­di­vo could beat chemother­a­py as a front­line treat­ment for a broad pa­tient pop­u­la­tion suf­fer­ing from non-small cell lung can­cer. We al­ready knew from the top-line an­nounce­ment that the tri­al failed — trig­ger­ing some­thing of a Russ­ian win­ter for Bris­tol stock. Now we know that it failed re­al­ly, re­al­ly bad­ly, and in­vestors weren’t hap­py, send­ing its shares down sharply Mon­day morn­ing.

Low­er­ing the bar to pa­tients with 5% or more of their can­cer cells ex­press­ing PD-L1, Bris­tol’s Op­di­vo de­layed tu­mor pro­gres­sion 4.2 months. Chemo? 5.9 months.

“We thought Op­di­vo could beat chemother­a­py, and we have an­swered the ques­tion — for the broad pop­u­la­tion it is not enough,” Fouad Namouni, on­col­o­gy de­vel­op­ment head at Bris­tol-My­ers, told David Crow at the Fi­nan­cial Times.

That’s ac­tu­al­ly a very valu­able point and in the sci­ence world it would and should be ap­plaud­ed. But even in sub­group analy­ses, Bris­tol’s in­ves­ti­ga­tors could find new ev­i­dence of suc­cess. To in­vestors ex­pect­ing Bris­tol-My­ers to con­tin­ue their dom­i­na­tion of the sec­tor, though, it all looks like an epic mis­cal­cu­la­tion and set­back with­out a sin­gle re­deem­ing fea­ture.

Mer­ck R&D chief Roger Perl­mut­ter $MRK made no such mis­take in mov­ing on the front­line mar­ket front. Play­ing Welling­ton in this R&D Wa­ter­loo, Perl­mut­ter fo­cused on pa­tients with a 50%-plus PD-L1 ex­pres­sion rate and round­ed up a 50% re­duc­tion in the risk of dis­ease pro­gres­sion and 40% plunge in risk of death com­pared to chemo in pre­vi­ous­ly un­treat­ed pa­tients.

This is what a new stan­dard of care for a seg­ment of front-line lung can­cer cas­es looks like. This drug is al­ready be­ing sold and you can bet that the phar­ma gi­ant will move as fast as it can to cap­i­tal­ize on this mar­ket. That’s a glo­ri­ous vic­to­ry by any bio­phar­ma stan­dard.

Over re­cent months Bris­tol-My­ers stock has re­treat­ed sig­nif­i­cant­ly while Mer­ck has ad­vanced. That’s how you can score the war. And Mon­day morn­ing Mer­ck stock bub­bled up an­oth­er 3% while Bris­tol-My­ers shares plunged 8%.

But Mer­ck won’t re­main un­chal­lenged. Steal­ing some of the thun­der at ES­MO is Genen­tech’s Tecen­triq. Roche’s big check­point, the third to be ap­proved and start spread­ing its wings, achieved a sol­id suc­cess in sec­ond-line NSCLC. Their 13.8 month me­di­an sur­vival rate com­pared fa­vor­ably with the 9.6 months record­ed for the chemo arm.

Dan Chen, who’s head­ed up can­cer im­munother­a­py de­vel­op­ment for Genen­tech, told Fier­cePhar­ma’s Car­ly Helfand that the da­ta were “es­sen­tial­ly un­prece­dent­ed.” But when you sin­gled out the high PD-L1 ex­pressers, the da­ta weighed even more heav­i­ly on Tecen­triq’s side: 20.5 months me­di­an sur­vival com­pared to 8.9 months in the chemo arm.

Now Roche $ROG can break out from its unique blad­der can­cer ap­proval and start to tear up the sec­ond-line lung can­cer mar­ket, look­ing for an ad­van­tage with all the high PD-L1 ex­pressers. A front­line pitch can’t be far off.

While Mer­ck, Bris­tol-My­ers and Roche are divvy­ing up the mar­ket, As­traZeneca is still side­lined af­ter its ef­forts fell well be­hind its ri­vals. But who was that stand­ing on the edge of the bat­tle­field?

“Sud­den­ly, this tri­al news opens quite some op­por­tu­ni­ties for us, in both monother­a­py and com­bi­na­tion ther­a­py,” a sun­ny As­traZeneca Chief Ex­ec­u­tive Pas­cal So­ri­ot told Reuters’ Ben Hirschler, siz­ing up the fast-chang­ing lung can­cer mar­ket.

As­traZeneca’s check­point pro­gram $AZN has been a lag­gard and will ar­rive to the fray very late. For So­ri­ot, though, it’s all char­ac­ter­ized as an ad­van­tage; a chance to see how oth­ers have done their stud­ies so they can match the best work. But af­ter a se­ries of clin­i­cal set­backs, As­traZeneca looks like its re­ced­ing from So­ri­ot’s promis­es of great ad­vances on the rev­enue front, 4 years af­ter he got the top job. He needs a piece of the check­point mar­ket—and fast.

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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