For­get Bris­tol-My­ers: Re­gen­eron takes on Mer­ck for the heavy­weight ti­tle in non-small cell lung can­cer

Re­gen­eron may have been the 6th bio­phar­ma com­pa­ny to land an ini­tial ap­proval for a PD-1/L1 ther­a­py, but they’re clear­ly not set­tling for any­thing close to a last-place fin­ish in the amaz­ing race for mar­ket dom­i­nance in the mega-block­buster field.

In their Q4 call with an­a­lysts on Thurs­day, Re­gen­eron’s not-shy R&D chief George Yan­copou­los tout­ed their cap­ture of the lead role among check­points in treat­ing ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma. In an in­ter­view with End­points News last month, Yan­copou­los made so se­cret of his opin­ions about the PD-L1s on the mar­ket, slam­ming them all as sec­ond-rate and as­sign­ing worst-in-class sta­tus to Baven­cio from Pfiz­er and Mer­ck KGaA. But they’re al­so mov­ing to chal­lenge gi­ant Mer­ck’s Keytru­da — an­oth­er PD-1 — on one of its ma­jor achieve­ments: win­ning an OK as a monother­a­py for front­line use in non-small cell lung can­cer.

Here’s Yan­copou­los from the call on his I/O strat­e­gy:

(W)e have dou­bled the size of our tri­al com­par­ing Lib­tayo monother­a­py to chemother­a­py in PD-L1-high pa­tients. Re­gard­ing com­bi­na­tions, we’ll be fo­cus­ing our ef­forts in first-line treat­ing and com­bi­na­tion ther­a­py of Lib­tayo with chemother­a­py. The on­go­ing Phase III com­bi­na­tion study is be­ing aug­ment­ed to en­roll non-small cell lung can­cer pa­tients ir­re­spec­tive of his­tol­ogy and the lev­els of PD-L1 ex­pres­sion and to ran­dom­ize to Lib­tayo plus chemother­a­py or chemother­a­py alone.

Amaz­ing­ly enough de­spite the years of ef­fort in many piv­otal tri­als there’s on­ly one PD-1 or PD-L1 an­ti­body ap­proved as monother­a­py in first-line metasta­t­ic non-small cell lung can­cer (Keytru­da). If our on­go­ing tri­als suc­ceed, we have the po­ten­tial to be the sec­ond.

Bris­tol-My­ers Squibb — which so far has pro­vid­ed Keytru­da its biggest chal­lenge with Op­di­vo — has been work­ing hard to over­come Mer­ck’s move to the top of the mar­ket, fo­cus­ing on a tu­mor mu­ta­tion­al bur­den ap­proach that has failed to gain much trac­tion.

Yan­copou­los was al­so quick to tout Re­gen­eron’s bis­pe­cif­ic strat­e­gy, fo­cus­ing on: “the CD3 bis­pecifics and the cos­tim­u­la­to­ry bis­pecifics. We be­lieve that these bis­pecifics may have im­por­tant an­ti­cancer ac­tiv­i­ty on their own and in com­bi­na­tions that can in­clude Lib­tayo.… Many of our CD3 bis­pecifics are al­ready in the clin­ic with one of them show­ing im­pres­sive ini­tial re­sults as a monother­a­py in very-ad­vanced late-stage pa­tients.”

“REGN1979 our CD20xCD3 bis­pe­cif­ic for B-cell Non-Hodgkin’s Lym­phoma or NHL” has achieved im­pres­sive re­sults, he not­ed, adding:

(O)ur BC­MAx­CD3 bis­pe­cif­ic an­ti­body has just en­tered clin­i­cal de­vel­op­ment for the treat­ment of mul­ti­ple myelo­ma. We’re en­cour­aged by pre­lim­i­nary re­sults of both CAR-T as well as BiTEs tar­get­ing BC­MA in mul­ti­ple myelo­ma and be­lieve that our BC­MAx­CD3 bis­pe­cif­ic has a po­ten­tial of be­ing an im­por­tant ad­di­tion in this new area.

“It’s us against the world,” Yan­copou­los told me in a meet­ing at JP Mor­gan. And the Re­gen­eron re­search chief gives the com­pa­ny good odds at win­ning, cit­ing his clear be­lief that the com­pa­ny has the best tech­nol­o­gy and drugs in hand to slam dunk the com­pe­ti­tion.

Im­age: George Yan­copou­los. GET­TY IM­AGES

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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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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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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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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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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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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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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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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