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.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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