In the lat­est twist to IL-6 roller coast­er, Roche's Actem­ra fails PhI­II Covid-19 Vek­lury com­bo tri­al

Roche is adding an­oth­er tal­ly mark to the neg­a­tive col­umn on Actem­ra’s mixed record in Covid-19.

The IL-6 drug failed to meet the pri­ma­ry end­point of REM­DAC­TA, where it was paired with Gilead’s ap­proved an­tivi­ral Vek­lury (remde­sivir) for the treat­ment of pa­tients with se­vere Covid-19 pneu­mo­nia. Adding Actem­ra didn’t im­prove time to hos­pi­tal dis­charge, the com­pa­ny re­port­ed, with­out break­ing down the num­bers.

Key sec­ondary end­points weren’t met, ei­ther, in­clud­ing like­li­hood of death, like­li­hood of pro­gres­sion to me­chan­i­cal ven­ti­la­tion or death, and clin­i­cal sta­tus.

Actem­ra — which is al­ready on the mar­ket for au­toim­mune con­di­tions such as rheuma­toid arthri­tis and re­cent­ly racked up a sixth ap­proval in sys­temic scle­ro­sis-as­so­ci­at­ed in­ter­sti­tial lung dis­ease — has tak­en in­ves­ti­ga­tors and sci­en­tists on a bit of a ride as Roche looked to pitch in on the glob­al fight against Covid-19.

Of the two pre­vi­ous Phase III stud­ies eval­u­at­ing the drug, one met the pri­ma­ry end­point while the oth­er didn’t. The suc­cess­ful tri­al, EM­PACTA, fo­cused on hos­pi­tal­ized pa­tients with pneu­mo­nia and saw Actem­ra cut the in­ci­dence of death or re­quir­ing me­chan­i­cal ven­ti­la­tion by day 28. In CO­V­AC­TA, though, the an­ti­body had failed to dif­fer­en­ti­ate from place­bo in terms of im­prov­ing clin­i­cal sta­tus for a more se­vere sub­group.

Levi Gar­raway

Since the CO­V­AC­TA read­out came first and along­side sim­i­lar dis­ap­point­ing news from Re­gen­eron and Sanofi around Kevzara, many had as­sumed it would spell an end to the idea of re­pur­pos­ing the IL-6 class to fight the im­mune re­sponse and lung dam­age that can re­sult from a coro­n­avirus in­fec­tion. But Roche — and CMO Levi Gar­raway — didn’t give up, and still won’t.

“We con­tin­ue to be­lieve that the to­tal­i­ty of da­ta sug­gests a po­ten­tial role for Actem­ra in treat­ing cer­tain pa­tients with COVID-19, and will dis­cuss the re­sults with health au­thor­i­ties,” he said in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Emma Walmsley, GlaxoSmithKline CEO (Kevin Dietsch/Pool via CNP/Alamy)

Glax­o­SmithK­line hus­tles the 7th PD-1 past the fin­ish line with Jem­per­li. But how big will up­take be?

Everything came up sevens for GlaxoSmithKline on Thursday as the pharma notched the seventh PD-1 approval seven years after the first such drugs were OK’ed in Keytruda and Opdivo. But will it bring GSK good fortune?

The FDA granted accelerated approval to dostarlimab, to be branded Jemperli, to treat recurrent or advanced endometrial cancer in a specific subset of patients following platinum-based chemo. It’s a drug that came to GSK through its buyout of Tesaro, which it snapped up for $5.1 billion back in December 2018.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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Sen. Patty Murray (D-WA) (Graeme Sloan/Sipa USA/Sipa via AP Images)

Sen­a­tors to NIH: Do more to pro­tect US bio­med­ical re­search from for­eign in­flu­ence

Although Thursday’s Senate health committee hearing was focused on how foreign countries and adversaries might be trying to steal or negatively influence biomedical research in the US, the only country mentioned by the senators and expert witnesses was China.

Committee chair Patty Murray (D-WA) made clear in her opening remarks that the US cannot “let the few instances of bad actors” overshadow the hard work of the many immigrant researchers in the US, many of which have won Nobel prizes for their work. But she also said, “There is more the NIH can be doing here.”

Covid-19 man­u­fac­tur­ing roundup: Mary­land looks to grow biotech ca­pac­i­ty with $400M check; Rus­sia lands sec­ond Sput­nik V part­ner this week

A Maryland real estate project has added three new biotech-focused manufacturing and research buildings to an office park to keep up with demand created by the pandemic, the Washington Business Journal reported.

The Milestone Business Park — located off of I-270 in Germantown, MD — will see the new buildings and a total of 532,000 square feet as the campus rebrands to Milestone Innovation Park.