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.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,500+ biopharma pros reading Endpoints daily — and it's free.

Jean-Christophe-Hyvert, Lonza

Lon­za look­ing to build on 'd­if­fer­en­ti­at­ed ad­van­tage' in Covid-19, CD­MO mar­ket­place in 2021

It’s not new for Lonza, the Swiss CDMO nearing its quasquicentennial anniversary, to be in the upper echelon of the biotech manufacturing industry.

But 2020 — as it was for many CDMOs — was a special year even by Lonza’s standards. The company inked a deal to produce 1 billion worldwide doses of Moderna’s Covid-19 vaccine and tapped pharma vet Pierre-Alain Ruffieux to lead its operations, moves which have allowed Lonza to make a myriad of other deals that will continue to ramp up its global production capacity.

Matt Gline (L) and Vivek Ramaswamy

Vivek Ra­maswamy and Matt Gline pen share­hold­er let­ters about the changes now un­der­way at Roivant

Friends and colleagues,

I am writing to provide our annual update on Roivant. These updates are usually restricted to our shareholders, but we are sharing this year’s letter more broadly to announce an upcoming change in my role from CEO to Executive Chairman and the promotion of Matt Gline to Chief Executive Officer.

Reflections on 2020

Much has transpired in the world and at our company since my last annual update in January 2020. One year ago we had just completed our $3 billion transaction with Sumitomo Dainippon Pharma (DSP), and we were evaluating how to reinvest in our business. At the same time, SARS-CoV-2 was still a distant virus barely on our minds. Today it has afflicted the entire world sparing literally no one from its effects.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.

Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Covid-19 roundup: Mod­er­na dou­bles down on Covid-19 with new boost­er tri­als; Aus­tralia plans do­mes­tic pro­duc­tion of As­traZeneca vac­cine amid dis­tri­b­u­tion lag

As Merck bows out of the global race to develop vaccines for Covid-19, Moderna is doubling down to make sure they can quell new variants that have recently emerged and quickly spread.

The Cambridge, MA-based biotech put out word on Monday that in vivo studies indicate their mRNA vaccine works well enough against two strains first detected in the UK and South Africa. But with a six-fold reduction in neutralizing titers observed against the latter strain, the company is launching a new study of a booster version to make sure it can do the job.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 98,500+ biopharma pros reading Endpoints daily — and it's free.

News brief­ing: Jef­frey Lei­den to chair Tmu­ni­ty board of di­rec­tors; Op­di­vo wins new ap­proval in ad­vanced RCC

Longtime Vertex CEO Jeffrey Leiden is taking on a new role.

Leiden has been appointed chairman of Tmunity’s board of directors, the company announced Monday. The move comes about a year and a half after Leiden announced he’d be stepping down from his position at Vertex.

Vertex saw immense growth under Leiden, leading the company from its exit out of hepatitis C, when cures were moving in, and into cystic fibrosis. The company’s cystic fibrosis triple combo therapy Trikafta is already its best-seller, reaching the distinction just six weeks after launch and recording the strongest first quarter of sales for any drug, per some estimates.