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.

Biotech and Big Phar­ma: A blue­print for a suc­cess­ful part­ner­ship

Strategic partnerships have long been an important contributor to how drugs are discovered and developed. For decades, big pharma companies have been forming alliances with biotech innovators to increase R&D productivity, expand geographical reach and better manage late-stage commercialization costs.

Noël Brown, Managing Director and Head of Biotechnology Investment Banking, and Greg Wiederrecht, Ph.D., Managing Director in the Global Healthcare Investment Banking Group at RBC Capital Markets, are no strangers to the importance of these tie-ups. Noël has over 20 years of investment banking experience in the industry. Before moving to the banking world in 2015, Greg was the Vice President and Head of External Scientific Affairs (ESA) at Merck, where he was responsible for the scientific assessment of strategic partnership opportunities worldwide.

No­var­tis' sec­ond at­tempt to repli­cate a stun­ning can­cer re­sult falls flat

Novartis’ hopes of turning one of the most surprising trial data points of the last decade into a lung cancer drug has taken another setback.

The Swiss pharma announced Monday that its IL-1 inhibitor canakinumab did not significantly extend the lives or slow the disease progression of patients with previously untreated locally advanced or metastatic non-small cell lung cancer when compared to standard of-care alone.

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AstraZeneca CEO Pascal Soriot (Raphael Lafargue/Abaca/Sipa USA)

A com­bo of As­traZeneca's Imfinzi and chemo wins where oth­ers have failed in piv­otal bil­iary tract test

Looking to run with the big dogs in the PD-(L)1 class, AstraZeneca’s Imfinzi has a tall hill to climb to compete in an increasingly bustling market. An aggressive combo strategy for the drug has paid off so far, and now AstraZeneca is adding another notch to its belt.

A combo of Imfinzi (durvalumab) and chemotherapy significantly extended the lives of first-line patients with advanced biliary tract cancer over chemo alone, according to topline results from the Phase III TOPAZ-1 study revealed Monday.

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Sean Ianchulev, Eyenovia CEO and CMO

Re­cent court de­ci­sion push­es FDA to re­ject and re­clas­si­fy drug-de­vice com­bo, crush­ing shares

Back in April, the FDA lost a crucial court case in which its broad discretion of regulating medical products that might satisfy the legal definitions of either “drug” and/or “medical device” was sharply curtailed.

In addition to the appeals court ruling that Genus Medical Technologies’ contrast agent barium sulfate (aka Vanilla SilQ) should not be considered a drug, as the FDA had initially ruled, but as a medical device, the agency also was forced to spell out which drugs would transition to devices as a result of the ruling.

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NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

Robert Califf (Pablo Martinez Monsivais, AP Images, File)

As buzz on Califf FDA nom heats up, in­dus­try and agency in­sid­ers of­fer a strong nod for the ‘per­fect’ choice

For once in this long, dramatic road to finding a new FDA commissioner, there’s been some continuity. Both CNN and Politico reported this weekend that Rob Califf met with President Biden to discuss the permanent commish role, following earlier news broken by the Washington Post that all signs point to Califf.

Although there may be a few Democrats who continue to grandstand about the dangers of COI (Califf has worked for Verily, sits on the board of Centessa Pharmaceuticals, and has other ties to industry research), with the pandemic ongoing and the need for some kind of continuity at FDA mounting, Califf is likely to meet the same fate as when he first won Senate confirmation in 2016, by a vote of 89-4 — Bernie Sanders and 6 others didn’t vote.

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Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Bluebird bio was hit with a patent infringement lawsuit last week from a Chicago-based biotech it has had an ongoing beef with calling for $2 billion to help cure the “irreparable harm” caused by alleged willful infringement.

Bluebird bio is facing a lawsuit from Errant Gene Therapeutics for violating patent law in two instances, the company says.

The suit alleges that bluebird infringed the rights of EGT’s recombinant vectors used in the gene therapy treatment of rare diseases such as sickle cell disease and beta thalassemia for its drugs Zynteglo and LentiGlobin. EGT has an exclusive license from the Memorial Sloan Kettering Cancer Center to patents titled “vector encoding human global gene and use thereof in treatment of Hemoglobinopathies.”

Joan Butterton, Merck Research Laboratories VP of global clinical development, infectious diseases (Merck)

Mer­ck­'s ex­per­i­men­tal HIV drug is­la­travir hits with a PhI­II com­bo win and FDA fil­ing plans

Back in March, Merck and Gilead agreed to a partnership to challenge GlaxoSmithKline on long-acting HIV meds — by combining one drug from both Merck and Gilead that had shown potential. While Gilead brought its capsid inhibitor lenacapavir, Merck brought islatravir into the deal — a small molecule that the pharma acquired in 2012 from a small Japanese firm.

While that partnership is ongoing, islatravir is coming out of 2 Phase III pivotal trials with back-to-back successes and plans to beat a quick advance to the FDA.

Gil Beyen, Erytech CEO

A transat­lantic biotech flags a painful PhI­II can­cer flop, wav­ing a white flag

More than 4 years after little Erytech inflated some rare passion for its stock with upbeat Phase IIb data for their lead drug in pancreatic cancer, they’ve let the air out of the party balloons.

The transatlantic biotech $ERYP put the word out Monday morning that its drug eryaspase flopped in a Phase III pivotal for second line metastatic pancreatic cancer, slamming its stock, which plunged more than 30%.