Bris­tol-My­ers stag­gered by a stun­ning check­point set­back, hands Mer­ck a free pass on front­line lung can­cer com­bo

Bris­tol-My­ers Squibb $BMY fans can scratch any hopes of an ac­cel­er­at­ed fil­ing for a com­bi­na­tion of Op­di­vo and Yer­voy as a front­line ther­a­py for lung can­cer. The big biotech an­nounced in a terse state­ment late Thurs­day that it will not pur­sue an ac­cel­er­at­ed ap­proval due to the “re­view of da­ta avail­able at this time.”

More in­sight? For­get about it. Says Bris­tol-My­ers:

“In or­der to pro­tect the in­tegri­ty of on­go­ing reg­is­tra­tional stud­ies, the com­pa­ny will not be pro­vid­ing ad­di­tion­al de­tails.”

The an­nounce­ment nix­es any hopes that the com­bo can pro­vide near-term re­lief from Mer­ck’s as­sault on the front­line fran­chise with its stun­ning ear­ly fil­ing on a com­bi­na­tion of Keytru­da and chemo for first line use. Bris­tol-My­ers’s work on Check­mate-227, the key clin­i­cal pro­gram that will de­cide the fate of Op­di­vo’s fu­ture, is ex­pect­ed to last in­to 2018.

Bris­tol-My­ers’ shares plunged 10% in ear­ly trad­ing Fri­day, elim­i­nat­ing more than $9 bil­lion in mar­ket cap. Its loss was Mer­ck’s gain, which saw its stock jump 4%. And As­traZeneca was caught in this vor­tex as well, with shares drop­ping 2% in pre-mar­ket trad­ing as an­a­lysts raised doubts about its strat­e­gy for dur­val­um­ab, which will play a crit­i­cal role in CEO Pas­cal So­ri­ot’s plan to make a come­back at the phar­ma gi­ant.

Mer­ck now has plen­ty of time to grab the lead with its own ear­ly com­bo ap­proach, as As­traZeneca still looks for a come-from-be­hind win on dur­val­um­ab and treme­li­mum­ab, with pro­gres­sion-free sur­vival da­ta slat­ed to ar­rive this sum­mer — though over­all sur­vival da­ta won’t like­ly ar­rive on that ex­per­i­men­tal com­bo un­til 2018 as well.

Sea­mus Fer­nan­dez, Leerink

Sea­mus Fer­nan­dez at Leerink had some time to con­sid­er the im­pact, and he was dis­turbed by the im­pli­ca­tions for Bris­tol-My­ers as well as As­traZeneca. He not­ed:

This is a clear set­back for BMY, par­tic­u­lar­ly in light of the agency’s re­cent ac­cep­tance of MRK’s (MP) fil­ing for the Keytru­da (pem­brolizum­ab; an­ti-PD-1) + chemother­a­py reg­i­men. With the CM-227 tri­al ex­pect­ed to read­out in 1H:18, this al­so could give AZN (OP) a pot’l head start with its dur­val­um­ab (an­ti-PD-L1) + treme­li­mum­ab (an­ti-CT­LA-4) com­bi­na­tion in 1L NSCLC, as­sum­ing pos­i­tive da­ta from the MYS­TIC tri­al (ex­pect­ed in mid-2017). How­ev­er, if MRK and RHH­BY’s (NR) Phase 3 IO+Chemo tri­als are both suc­cess­ful and IO+IO com­bos fail to im­press, this would leave very lit­tle room for ei­ther BMY or AZN to dif­fer­en­ti­ate them­selves in the 1L NSCLC mar­ket. This would be par­tic­u­lar­ly sur­pris­ing and dis­ap­point­ing in the wake of our re­cent dis­cus­sions with lung can­cer KOLs.

In an­oth­er ma­jor set­back for Bris­tol-My­ers Squibb, its first piv­otal study for Op­di­vo in front­line lung can­cer failed last year, in part be­cause in­ves­ti­ga­tors de­cid­ed to tack­le a broad swathe of pa­tients. Its con­sis­tent­ly dis­ap­point­ing re­sponse on lung can­cer has ran­kled an­a­lysts and in­vestors, who once gam­bled that Bris­tol would be the king­pin in check­point drugs.

Mer­ck $MRK in the mean­time, is fol­low­ing up with dozens of stud­ies of Keytru­da com­bos. Just a few days ago the com­pa­ny turned heads once again with plans to com­bine Keytru­da with In­cyte’s IDO1 in­hibitor epaca­do­stat in lung can­cer and sev­er­al oth­er on­col­o­gy in­di­ca­tions.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

Dan Gold, MEI Pharma CEO

De­vel­op­ment part­ners at MEI, Helsinn dump a high-risk PhI­II AML study af­ter con­clud­ing it would fail sur­vival goal

Four years after Switzerland’s Helsinn put $25 million of cash on the table for an upfront and near-term milestone to take MEI Pharma’s drug pracinostat into a long-running Phase III trial for acute myeloid leukemia, the partners are walking away from a clinical pileup.

The drug — an HDAC inhibitor — failed to pass muster during a futility analysis, as researchers concluded that pracinostat combined with azacitidine wasn’t going to outperform the control group in the pivotal.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”