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.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

Fol­low­ing SCO­TUS de­ci­sion to over­turn abor­tion pro­tec­tions, AG Gar­land says states can't ban the abor­tion pill

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Joe Wiley, Amryt Pharma CEO

Am­ryt Phar­ma sub­mits a for­mal dis­pute res­o­lu­tion to the FDA over re­ject­ed skin dis­ease drug

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

Sen. Thom Tillis (R-NC) (J. Scott Applewhite/AP Images)

Phar­ma-friend­ly sen­a­tor calls on FDA for a third time to show patent pro­tec­tions should­n't be blamed for high drug prices

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”

EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s human medicines committee on Friday recommended three new drugs for approval or conditional approval, even as their US counterparts have rejected these three for various reasons.

In a major move, CHMP offered a thumbs-up to a conditional marketing authorization for the first gene therapy to treat severe hemophilia A, although the agency cautioned that it’s so far unknown how long the effects of infusion will last.

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