J&J, GSK stum­ble com­ing out of the gate with mixed PhI­II rheuma­toid arthri­tis da­ta for sirukum­ab

This is a big week­end for the wave of late-stage drugs lin­ing up for a slice of the multi­bil­lion-dol­lar rheuma­toid arthri­tis mar­ket. And J&J and Glax­o­SmithK­line got things start­ed by spelling out the da­ta in a less-than-stel­lar matchup against Ab­b­Vie’s Hu­mi­ra.

In­ves­ti­ga­tors turned up at the an­nu­al Amer­i­can Col­lege of Rheuma­tol­ogy meet­ing in Wash­ing­ton DC to re­port a hit and a miss in a Phase III head-to-head be­tween sirukum­ab — a top rheuma­toid arthri­tis drug in both J&J’s as well as GSK’s late-stage pipeline — and Hu­mi­ra.

Pa­tients tak­ing 50 mg of sirukum­ab dosed every 4 weeks and 100 mg dosed every two weeks achieved some­what bet­ter re­spons­es — a 2.58 and 2.96 drop from base­line on the dis­ease ac­tiv­i­ty score —  than the 2.19 drop for pa­tients tak­ing a low­er 40 mg dose of Hu­mi­ra every two weeks. That was a sta­tis­ti­cal­ly sig­nif­i­cant re­sponse.

That Hu­mi­ra reg­i­men, though, beat the 50 mg sirukum­ab dose on hit­ting ACR50, a min­i­mum 50% im­prove­ment in signs and symp­toms of the dis­ease, and bare­ly missed match­ing the 100 mg dose, miss­ing the sec­ond pri­ma­ry end­point in the study. The 50 mg and 100 mg sirukum­ab num­bers hit 27% and 35% on ACR50 com­pared to 32% of the Hu­mi­ra group.

The high dose of sirukum­ab al­so reg­is­tered a high­er rate of se­ri­ous ad­verse events in the 50 mg group, with 7% re­port­ing a se­ri­ous AE com­pared to 3% in the 100 mg group and 4% tak­ing Hu­mi­ra.

In the sec­ond Phase III study among pa­tients re­sis­tant to an­ti-TNF drugs, like Hu­mi­ra, the ACR20 scores were 40% and 45% for the 50 mg and 100 mg sirukum­ab dos­es and 24% in the place­bo arm.

None of that spells dis­as­ter for this drug. But it’s just one of sev­er­al new con­tenders for the mar­ket crown and pay­ers will be de­vot­ing par­tic­u­lar­ly close at­ten­tion to the head-to-head num­bers for Hu­mi­ra, as biosim­i­lars are lin­ing up to dec­i­mate the $14 bil­lion fran­chise — soon­er or lat­er.

J&J has re­peat­ed­ly tapped sirukum­ab as a key part of its Phase III ef­fort to line up ma­jor new prod­ucts for the mar­ket­ing group. GSK, mean­while, has been try­ing to over­come per­sis­tent crit­i­cism that its pipeline lacks piz­zazz. In their deal on sirukum­ab, GSK gained com­mer­cial rights in the US and the West­ern Hemi­sphere, while J&J lined up Eu­rope and the rest of the world.

Still to come this week­end: New da­ta on Eli Lil­ly’s baric­i­tinib, an oral ri­val in-li­censed from In­cyte. Sanofi and Re­gen­eron are grap­pling with a re­cent re­jec­tion for their IL-6 con­tender sar­ilum­ab, stiff-armed by the FDA due to man­u­fac­tur­ing con­cerns, which al­so post­ed a su­pe­ri­or pro­file to Hu­mi­ra for rheuma­toid arthri­tis.

And fur­ther back in the pipeline are even more big drugs that will look to grab best-in-class sta­tus.

A few weeks ago Ab­b­Vie turned its back on Abl­ynx’s Phase III-ready IL-6 drug vo­bar­il­izum­ab, shrug­ging off its $175 mil­lion up­front buy-in, af­ter that drug al­so turned in an unim­pres­sive per­for­mance com­pared to Roche’s Actem­ra. Ab­b­Vie is look­ing to its own in-house pro­gram for ABT-494 to pro­duce the best new drug in the field. Gilead stepped in af­ter Ab­b­Vie al­so spurned its part­ner­ship with Gala­pa­gos on fil­go­tinib, pay­ing $725 mil­lion to ac­quire rights to the JAK1 drug.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

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.