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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Tony Johnson, Goldfinch Bio CEO (Goldfinch via YouTube)

Kid­ney dis­ease drug­mak­er Goldfinch Bio shuts down

Goldfinch Bio, attempting to make treatments for kidney diseases and diabetic nephropathy, is shutting down.

President and CEO Tony Johnson confirmed to Endpoints News Friday afternoon that the biotech shut down after “fundraising challenges in the current macro-environment.” Fierce Biotech first reported the news.

Johnson, who joined in 2017 after a stint as SVP of early clinical development at AstraZeneca, said in a text that the company “entered the ABC process recently,” referring to an assignment for the benefit of the creditors, which provides a different wind-down avenue than a bankruptcy.

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Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.