Deaths de­rail Juno's launch count­down, giv­ing Kite and No­var­tis the lead

The FDA’s hold on Juno Ther­a­peu­tics’ lead CAR-T pro­gram, JCAR015, last­ed on­ly six days. But the de­rail­ment was se­ri­ous enough to push its ex­pect­ed ap­proval date from 2017 back in­to 2018, leav­ing Kite Phar­ma and No­var­tis an­gling for the first ap­provals in the field in 2017.

Juno CEO Hans Bish­op

“Re­gard­ing the ROCK­ET tri­al,” Juno CEO Hans Bish­op told an­a­lysts Thurs­day evening, “the process of get­ting IRB ap­proval across mul­ti­ple sites along with the gat­ed en­roll­ment for the next six pa­tients leaves us to now es­ti­mat­ing ap­proval as ear­ly as the first half of 2018.”

The new H1 2018 pro­jec­tion marks a set­back for Juno, which had been seen as run­ning neck and neck with Kite in the race to get the land­mark ap­proval for a new can­cer ther­a­py that takes cells from pa­tients and reengi­neers them in­to a can­cer cell at­tack ve­hi­cle.

The hold last month, fol­low­ing the death of sev­er­al pa­tients from lethal cas­es of cere­bral ede­ma, stunned long­time ob­servers of Juno. The biotech quick­ly and suc­cess­ful­ly ap­pealed to the agency to lift the hold, say­ing they be­lieved that adding flu­dara­bine to its pre­con­di­tion­ing reg­i­men for pa­tients — prep­ping them to bet­ter re­spond to their CAR-T — had cre­at­ed a tox­ic com­bi­na­tion with the ther­a­py, killing 4 pa­tients. Reg­u­la­tors, who had al­so placed the same ther­a­py briefly on hold af­ter cy­tokine re­lease syn­drome al­so killed some pa­tients ear­ly on, were quick to re­spond af­fir­ma­tive­ly.

The de­lay leaves JCAR015 poised to en­ter the mar­ket just a year ahead of JCAR017. Bish­op de­scribes the sec­ond drug as “the back­bone of our CD19 fran­chise,” which is aimed at NHL, pe­di­atric and adult ALL and CLL.

Juno, though, is al­so mov­ing a va­ri­ety of pro­grams across a broad R&D front, and is now go­ing af­ter mul­ti­ple myelo­ma in a new pact that ropes in long­time col­lab­o­ra­tors at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter.

In a sep­a­rate press re­lease, the Seat­tle-based biotech an­nounced Thurs­day evening that it had struck a deal with MSK and Eu­re­ka Ther­a­peu­tics for IP on bind­ing do­mains need­ed to com­mer­cial­ize a CAR-T for mul­ti­ple myelo­ma. These bind­ing do­mains were de­vel­oped in a pact that Eu­re­ka and MSK had struck ear­li­er.

That deal is par­tic­u­lar­ly sig­nif­i­cant, as it in­volves a ful­ly-hu­man bind­ing do­main tar­get­ing B-cell mat­u­ra­tion anti­gen (BC­MA), along with bind­ing do­mains against two ad­di­tion­al undis­closed mul­ti­ple myelo­ma tar­gets. The BC­MA pact puts Juno on a po­ten­tial col­li­sion course with blue­bird bio, which al­so chose that tar­get in a col­lab­o­ra­tion its pur­su­ing with Cel­gene. Those two play­ers re­struc­tured their deal last year to con­cen­trate on BC­MA and Cel­gene lat­er signed a ma­jor pact with Juno as well.

Pfiz­er and Cel­lec­tis are al­so aim­ing at BC­MA in their col­lab­o­ra­tion, but they’re con­cen­trat­ing on a sec­ond-gen, off-the-shelf prod­uct.

Juno CSO Hy Lev­it­sky

“We ex­pect the BC­MA CAR to en­ter hu­man test­ing as ear­ly as the first half 2017,” Juno CSO Hy Lev­it­sky told an­a­lysts. “We’re op­ti­mistic the CAR T cell ther­a­py can be an im­por­tant com­po­nent in treat­ing pa­tients with mul­ti­ple myelo­ma. And we are pleased to bring ad­di­tion­al ful­ly hu­man body do­main against BC­MA and oth­er tar­gets in­to our pro­gram. We be­lieve that a mul­ti-pronged ap­proach may be nec­es­sary to treat this dis­ease and hence the im­por­tance of ac­cess to sev­er­al hu­man con­structs spe­cif­ic for more than one tar­get.”

This isn’t the first such pact that Juno and Eu­re­ka have struck. Back at the be­gin­ning of the year the two com­pa­nies struck a deal on a ful­ly hu­man bind­ing do­main that tar­gets MUC16. These bind­ing do­mains play a key role in im­prov­ing cell per­sis­tence, amp­ing up their ef­fect on pa­tients. And the in­tense ri­val­ry to dom­i­nate the first wave of com­mer­cial CAR-Ts to hit the mar­ket has spurred an arms race for the best tech with the most po­ten­tial.

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.

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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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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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.

Paul Perreault, CSL Behring CEO

CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

Blaise Coleman, Endo International CEO

En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.