Anirvan Ghosh, Unity Biotechnology CEO

A month af­ter los­ing its lead pro­gram, Uni­ty Biotech­nol­o­gy cuts 30% of staff in re­struc­tur­ing

Uni­ty Biotech­nol­o­gy’s lead an­ti-ag­ing pro­gram faced the chop­ping block last month fol­low­ing a ma­jor Phase II flop. And now, 30% of its staff are next, as the com­pa­ny re­struc­tures to fo­cus on oph­thal­mol­o­gy and neu­rol­o­gy.

The staff re­duc­tion will leave San Fran­cis­co-based Uni­ty $UBX with 75 full-time em­ploy­ees by the end of the year. It’s yet an­oth­er blow to the celebri­ty-fund­ed biotech, which has been laser-fo­cused on clear­ing senes­cent cells to po­ten­tial­ly re­duce the symp­toms of ag­ing.

In the last 10 years, Uni­ty has at­tract­ed in­vestors like Jeff Be­zos, Pe­ter Thiel and Arch Ven­ture Part­ners’ Bob Nelsen — rak­ing in more than $200 mil­lion in fund­ing. But last month, it missed the mark in a 183-per­son Phase II study test­ing UBX0101 for os­teoarthri­tis of the knee. Pa­tients on the treat­ment arms showed vir­tu­al­ly no dif­fer­ence com­pared to pa­tients on the place­bo arm, and as a re­sult of the news, the biotech’s mar­ket val­ue plunged 60%.

De­spite the set­back, CEO Anir­van Ghosh re­mained con­fi­dent in Uni­ty’s pre­clin­i­cal pipeline. “Our con­fi­dence in senes­cent cells dri­ving dis­ease bi­ol­o­gy re­mains strong,” he told in­vestors last month. “Not on­ly be­cause of work we’ve done in­ter­nal­ly, but al­so be­cause of the wealth of da­ta from labs that con­tin­ue to in­di­cate both that senes­cent cells ac­cu­mu­late dur­ing dis­eases of ag­ing and that elim­i­nat­ing them with tar­get­ed mech­a­nisms can pro­vide ben­e­fit.”

The biotech is hop­ing to send its di­a­bet­ic mac­u­lar ede­ma can­di­date, UBX1325, in­to Phase I by the end of the year. It’s de­signed to tar­get Bcl-xL, thus elim­i­nat­ing senes­cent cells to po­ten­tial­ly treat age-re­lat­ed eye dis­eases. Plus, the biotech is keep­ing UBX1967 in its pock­et — a “mol­e­c­u­lar­ly dis­tinct back­up to UBX1325.”

If all goes ac­cord­ing to plan, Uni­ty ex­pects to dose the first pa­tients in a Phase I study of UBX1325 lat­er this year.

“Uni­ty is a pi­o­neer in the de­vel­op­ment of ther­a­peu­tics tar­get­ing senes­cent cells at the crux of many age-re­lat­ed dis­eases, and we will con­tin­ue to build on this sci­en­tif­ic foun­da­tion as we ad­vance our pipeline,” Ghosh said in a state­ment.

The com­pa­ny says the staff re­duc­tion will ex­tend its cash run­way through mid-2022, and it’s go­ing to keep push­ing its pipeline to­ward the clin­ic.

“Mov­ing for­ward we will have a lean­er and more ag­ile team, which is well-re­sourced to ad­vance our pipeline pro­grams to key mile­stones,” Ghosh added lat­er.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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