Ilan Ganot, Solid Bio CEO

Lay­offs hit an­oth­er biotech as Duchenne play­er Sol­id Bio cuts staff by 35%

An­oth­er biotech has joined the ranks of the re­or­ga­nized, as Duchenne play­er Sol­id Bio­sciences re­port­ed a new way of do­ing things Wednes­day and an­nounced lay­offs and a C-suite de­par­ture.

Sol­id Bio is re­duc­ing its work­force by 35%, ac­cord­ing to an SEC fil­ing for its first-quar­ter re­sults Wednes­day, in ad­di­tion to a new em­pha­sis on its two gene ther­a­pies. The pipeline shift in­cludes an out­sourced man­u­fac­tur­ing process rather than what was used pre­vi­ous­ly, al­low­ing for a more stream­lined de­vel­op­ment process, the com­pa­ny said.

“We be­lieve that a new, out­sourced process may pro­vide im­prove­ments to man­u­fac­tura­bil­i­ty as well as ad­di­tion­al or­ga­ni­za­tion­al ef­fi­cien­cies,” Sol­id Bio said in its 10-Q. “We an­tic­i­pate that the use of trans­fec­tion-based man­u­fac­tur­ing process­es for both SGT-001 and SGT-003, will al­low us to fo­cus our op­er­at­ing struc­ture and bet­ter lever­age ex­ter­nal man­u­fac­tur­ing ex­per­tise.”

Joel Schnei­der

On top of all this, COO Joel Schnei­der will leave the com­pa­ny at the end of May to be­come CEO of a pri­vate gene ther­a­py biotech. Shares of Sol­id Bio $SLDB, al­ready a pen­ny stock, did not re­act much to the news, drop­ping about 1% in ear­ly Wednes­day trad­ing.

Wednes­day doesn’t mark the first time Sol­id Bio has run in­to some set­backs. Its lead gene ther­a­py, dubbed SGT-001 and de­signed to treat Duchenne mus­cu­lar dy­s­tro­phy, has run in­to sev­er­al road­blocks at the FDA in­clud­ing mul­ti­ple clin­i­cal holds over the last few years.

The holds have since been lift­ed, but an ini­tial da­ta cut re­leased in March 2021 did not ap­pear to in­vig­o­rate in­vestors as much as the biotech hoped. Though the tri­al was de­signed to eval­u­ate mi­crody­s­trophin pro­tein ex­pres­sion and dis­tri­b­u­tion, Sol­id Bio em­pha­sized func­tion­al and pa­tient-re­port­ed out­comes at the 12-month mark in­stead.

At the time, an­a­lyst Joseph Schwartz said the re­sults rep­re­sent­ed a “glimpse” of hope in the drug’s ef­fec­tive­ness. But in an in­vestor call Wednes­day, Schwartz still ap­peared un­sat­is­fied with the biotech’s abil­i­ty to mit­i­gate the risk for pa­tients. He asked ex­ecs about how Sol­id Bio is set­ting up its pro­to­col to en­sure pa­tients can tol­er­ate the drug, giv­en the new man­u­fac­tur­ing process.

Rox­ana Don­isa Dreghi­ci

Rox­ana Don­isa Dreghi­ci, Sol­id Bio’s head of clin­i­cal de­vel­op­ment, ac­knowl­edged that though the com­pa­ny is con­fi­dent in its pro­to­col, there still may be some changes.

“We’ve def­i­nite­ly op­ti­mized our fol­low up of the pa­tients of pre­vi­ous two in­fu­sions and in­fu­sions af­ter the first cou­ple of weeks of mon­i­tor­ing,” she said, al­lud­ing to pa­tients who took the drug be­fore the man­u­fac­tur­ing shift. “We’re mak­ing sure every­thing is still ap­plic­a­ble for the new ma­te­r­i­al.”

CEO Ilan Gan­ot added that Sol­id Bio has al­ready start­ed en­gag­ing with reg­u­la­tors about the changes, and in­tends to be ready to dose in ear­ly 2023. Sol­id Bio had pre­vi­ous­ly part­nered with Forge Bi­o­log­ics on man­u­fac­tur­ing, but is “build­ing a new re­la­tion­ship” with an­oth­er un­named ven­dor to pro­duce SGT-001, he said.

Wednes­day’s news comes amidst a tsuna­mi wave of lay­offs across the biotech sec­tor, with seem­ing­ly a new com­pa­ny an­nounc­ing a “re­struc­tur­ing” every day. It’s a much dif­fer­ent en­vi­ron­ment than the in­dus­try saw dur­ing the peak months of Covid-19 quar­an­tine, sig­ni­fied by a stark fig­ure — as of Tues­day, the XBI fell to the same lev­el it was in April 2020, when the pan­dem­ic was in its ear­ly months.

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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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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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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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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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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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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