In the bat­tle against kid­ney can­cer, Mer­ck­'s key­stone im­munother­a­py Keytru­da edges in front

Mer­ck $MRK may not just have a leg up over Bris­tol-My­ers Squibb $BMY in the lu­cra­tive field of lung can­cer. It looks like the com­pa­ny’s block­buster check­point in­hibitor Keytru­da — large­ly con­sid­ered the pre­em­i­nent im­munother­a­py — is on its way to es­tab­lish­ing its edge in re­nal can­cer. Ahead of the Gen­i­touri­nary (GU) Can­cers Sym­po­sium lat­er this week, an ab­stract de­tail­ing the re­sults of a piv­otal study test­ing a Keytru­da com­bi­na­tion in pre­vi­ous­ly un­treat­ed re­nal cell car­ci­no­ma (RCC) pa­tients ce­ment­ed the PD-1 drug’s lead­ing sta­tus.

Topline da­ta re­leased last Oc­to­ber showed a com­bi­na­tion of Keytru­da and Pfiz­er’s $PFE ty­ro­sine ki­nase in­hibitor (TKI) In­ly­ta in the KEYNOTE-426 tri­al im­proved over­all sur­vival, pro­gres­sion-free sur­vival and over­all re­sponse rates across risk groups and re­gard­less of PD-L1 sta­tus, com­pared to Pfiz­er’s Su­tent, in first-line RCC pa­tients. Mer­ck of­fered fur­ther de­tail on Mon­day, in­di­cat­ing the Keytru­da com­bo sig­nif­i­cant­ly im­proved OS, re­duc­ing the risk of death by near­ly half (HR 0.53), as well as PFS (HR 0.69).

An­a­lysts cheered the da­ta. Cowen an­a­lysts sug­gest­ed that a TKI/IO com­bo will emerge as the stan­dard of care in first line RCC, and that they an­tic­i­pate sim­i­lar re­sults to emerge from the on­go­ing Check­Mate 9ER tri­al, which is test­ing a com­bi­na­tion of Op­di­vo and Ex­elix­is’ $EX­EL TKI Cabome­tyx ver­sus Su­tent in RCC pa­tients.

Keytru­da+In­ly­ta showed im­pres­sive over­all re­sults and will like­ly gain ap­proval in 1L set­ting. While these da­ta may cause some volatil­i­ty in EX­EL stock…the on­go­ing Check­Mate 9ER tri­al should re­port sim­i­lar if not bet­ter re­sults…Cabo re­mains the pre­ferred TKI for RCC based on NC­CN guide­lines. Ad­di­tion­al­ly, we an­tic­i­pate that many physi­cians will view KEYNOTE-426 as a class ef­fect (strong syn­er­gy be­tween TKI and check­point in­hibitor), and this may even re­sult in an in­cre­men­tal in­crease in cabo use in the front­line set­ting with a check­point in­hibitor pri­or to Check­Mate 9ER re­sults and po­ten­tial la­bel ex­pan­sion.

Cred­it Su­isse’s Vi­mal Di­van said the Keytru­da com­bo’s OS haz­ard ra­tio sur­passed ex­pec­ta­tions, con­sid­er­ing in­vestors had an­tic­i­pat­ed a HR around the 0.60 thresh­old.

“Bris­tol-My­ers has been gain­ing share in the 1L RCC mar­ket with their Op­di­vo + Yer­voy com­bo but Mer­ck’s da­ta ap­pears su­pe­ri­or giv­en a low­er OS HR, a pos­i­tive im­pact on PFS and an im­pact be­ing seen across a broad­er pop­u­la­tion. Op­di­vo + Yer­voy showed an OS ben­e­fit (but not a PFS ben­e­fit) over Su­tent in the Check­Mate-214 tri­al but on­ly in in­ter­me­di­ate and high-risk pa­tients and the ben­e­fit, in our view, be­ing dri­ven by the re­spons­es seen in pa­tients that were PD-L1 pos­i­tive. Over time, the avail­abil­i­ty of a gener­ic ver­sion of In­ly­ta (we as­sume in 2025) could al­so pro­vide a cost ad­van­tage for the Keytru­da + In­ly­ta reg­i­men over Op­di­vo + Yer­voy,” Di­van said.

In its fourth-quar­ter earn­ings call, Mer­ck said it has al­ready sub­mit­ted an ap­pli­ca­tion to mar­ket Keytru­da to treat first line RCC pa­tients, but Pfiz­er and Mer­ck KGaA on Mon­day said the FDA had agreed to a speedy re­view for their ap­pli­ca­tion to mar­ket a com­bi­na­tion of their check­point in­hibitor Baven­cio and In­ly­ta in RCC pa­tients — the agency is ex­pect­ed to make its de­ci­sion by June.

“(The) Baven­cio com­bi­na­tion with In­ly­ta may get to mar­ket in the US first, hav­ing been grant­ed pri­or­i­ty re­view by the FDA…based on da­ta from JAVELIN Re­nal 101. How­ev­er, we view Keytru­da + In­ly­ta as like­ly to over­take Baven­cio + In­ly­ta as well giv­en greater physi­cian com­fort with Keytru­da over Baven­cio and the pos­i­tive OS da­ta that KEYNOTE-426 de­liv­ered at the first in­ter­im analy­sis (as com­pared to JAVELIN Re­nal 101 where we on­ly saw a PFS ben­e­fit at the in­ter­im analy­sis),” Di­van added.

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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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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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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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.