Vi­tal Ther­a­pies evis­cer­at­ed as PhI­II dis­as­ter forces it to dis­card sole as­set

Vi­tal Ther­a­pies has built its whole op­er­a­tion up­on the cell-based treat­ment for acute liv­er fail­ure it calls ELAD. That foun­da­tion has now col­lapsed.

Rus­sell Cox

The San Diego-based biotech an­nounced that ELAD failed both pri­ma­ry and sec­ondary end­points in a Phase III tri­al, show­ing no sig­nif­i­cant im­prove­ment in over­all sur­vival or pro­por­tion of sur­vivors at study day 91 for pa­tients with se­vere al­co­holic he­pati­tis. See­ing no short path to ap­proval, Vi­tal has de­cid­ed to “cease any fur­ther de­vel­op­ment of the ELAD Sys­tem and ex­plore strate­gic op­tions.”

In­vestors fol­lowed the ther­a­py out the door, send­ing Vi­tal shares $VTL down more than 88% in pre-mar­ket trad­ing. It’s now trad­ing at $0.70, a frac­tion of its IPO price in 2014.

Some may have seen this com­ing. Vi­tal pushed its way in­to Phase III clinch­ing a post hoc sub­set analy­sis of an oth­er­wise failed Phase II study, which con­vinced ex­ecs they stood a good chance of suc­cess if they on­ly fo­cused on younger pa­tients with a less se­vere form of the dis­ease.

The year was 2015, and the com­pa­ny had $62 mil­lion in the bank to com­plete a new tri­al, meant to yield re­sults that would sup­port a BLA fil­ing in 2019. As of June 30, $31.1 mil­lion of that re­mained in­tact, which they ex­pect­ed to last un­til the first quar­ter of 2019.

ELAD, short for ex­tra­cor­po­re­al liv­er as­sist sys­tem, fea­tures hu­man liv­er-de­rived cells and a de­vice to pump the pa­tient’s blood through these VTL-C3A cells, then back to their body. Vi­tal once drummed up hopes for the drug-de­vice in oth­er in­di­ca­tions — acute flares of vi­ral he­pati­tis B, trans­plant set­tings, and post-sur­gi­cal main­te­nance for liv­er can­cer pa­tients.

“Al­though we did not achieve the out­come we were hop­ing for, we would like to thank those who made this tri­al pos­si­ble, in­clud­ing our in­ves­ti­ga­tors and their staffs, the pa­tients who were en­rolled and their fam­i­lies, and all Vi­tal Ther­a­pies em­ploy­ees,” said CEO Rus­sell Cox, a Jazz Phar­ma vet who took the helm just be­fore the tri­al launched.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

Up­dat­ed: Hit by an­oth­er PhI­II flop, Sanofi culls breast can­cer drug — sound­ing alarm for the class

Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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