Bob Nelsen (Getty Images)

Bob Nelsen ex­its board and pres­i­dent steps down at Uni­ty as fall­out from the an­ti-ag­ing biotech's PhII miss con­tin­ues

Uni­ty Biotech­nol­o­gy is still reel­ing rough­ly four months af­ter ax­ing its lead pro­gram, as it saw sig­nif­i­cant change at the ex­ec­u­tive lev­el Mon­day.

The com­pa­ny an­nounced that ARCH Ven­ture Part­ners’ Bob Nelsen, one of Uni­ty’s co-founders back in 2011, has left the board. In ad­di­tion, pres­i­dent and co-founder Ned David is step­ping down at the end of the year, and an­oth­er board mem­ber, David Lacey, is al­so leav­ing the biotech.

With the de­par­tures, Uni­ty is ap­point­ing Gilmore O’Neill to the board to chair the com­pa­ny’s sci­ence com­mit­tee.

“We are in­cred­i­bly grate­ful to Ned, Bob and Dave for their ser­vice,” chair­man Kei­th Leonard said in a state­ment. “Ned’s ear­ly re­search in­to fun­da­men­tal path­ways of ag­ing bi­ol­o­gy form the foun­da­tion of UNI­TY. Bob played an in­stru­men­tal role in cre­at­ing and shap­ing a com­pa­ny tar­get­ing dis­eases of ag­ing, and David’s drug dis­cov­ery in­sights have shaped our pipeline.”

Mon­day’s moves were not the first de­par­tures since Uni­ty’s lead pro­gram flopped a ma­jor Phase II in os­teoarthri­tis of the knee in Au­gust. That whiff set this re­struc­tur­ing in mo­tion, and Nelsen had long been one of the head­lin­ers in a celebri­ty group of in­vestors that al­so in­clud­ed Jeff Be­zos and Pe­ter Thiel. Uni­ty had raised more than $200 mil­lion over the last decade, hop­ing its big-name part­ners could vault it to the fore­front of the buzzy an­ti-ag­ing field.

The com­pa­ny pre­vi­ous­ly said in Sep­tem­ber it was slash­ing its work­force by 30% in or­der to con­tin­ue its re­fo­cus­ing to­ward oph­thal­mol­o­gy and neu­rol­o­gy, putting the San Fran­cis­co-based biotech on track to em­ploy 75 full-timers by the end of 2020.

Au­gust’s tri­al miss it­self in­volved a 183-per­son study for what was then Uni­ty’s on­ly clin­i­cal pro­gram, UBX0101. Pa­tients in the treat­ment arms showed vir­tu­al­ly no dif­fer­ence com­pared to those tak­ing place­bo, and the can­di­date didn’t even reg­is­ter a dose-de­pen­dent re­sponse.

On­ly pa­tients who re­ceived the low­est dose nu­mer­i­cal­ly out­per­formed the con­trol, but the p-val­ue clocked in at an abysmal p=0.52.

Uni­ty’s big the­o­ry re­volves around what are known as senes­cent cells — non-di­vid­ing cells that clut­ter an ag­ing body. Uni­ty says the buildup in such cells is as­so­ci­at­ed with the re­lease of dozens of pro­teins that pro­mote in­flam­ma­tion, and re­mov­ing them, with­out al­ter­ing the bal­ance of cells the body needs, could pro­mote a longer, health­i­er life.

With the os­teoarthri­tis pro­gram scrapped, Uni­ty is now fo­cus­ing on a dif­fer­ent group of senes­cent cells for eye dis­eases. The next ex­per­i­men­tal drug is UBX1325, which is de­signed to tar­get Bcl-xL. And if all goes ac­cord­ing to plan, Uni­ty ex­pects to dose the first pa­tients in a Phase I study for the can­di­date lat­er this year.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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So what hap­pened with No­var­tis' gene ther­a­py group? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Vicente Anido (University of West Virginia via YouTube)

Aerie fires CEO af­ter lead pro­gram flop, com­ments about pri­ma­ry end­points be­ing 'not re­quired'

Aerie Pharmaceuticals CEO Vicente Anido has left the company less than a week after trying to chart a Phase III study in the wake of a serious Phase IIb flop.

Anido’s last day at Aerie was Friday, the biotech announced in a news release Tuesday morning, and Benjamin McGraw is taking his place in an interim role. The now former CEO was terminated without cause, according to an SEC filing.

The board has started looking for a full-time chief to take his place.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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