Ex­e­lead inks deal to man­u­fac­ture lipid nanopar­ti­cles for Pfiz­er/BioN­Tech vac­cine

For the two lead­ing Covid-19 vac­cines, mR­NA is the star of the show — and the mi­cro­scop­ic lipids used to trans­port that ther­a­py in­to cells have tak­en a much less vis­i­ble back­seat. But that doesn’t mean that de­liv­ery tech isn’t in high de­mand, and now an­oth­er CD­MO is chip­ping in to help Pfiz­er/BioN­Tech’s shot along.

Drew An­dis

In­di­anapo­lis-based Ex­e­lead will add 50 po­si­tions to han­dle the in­creased work­load tied to the Pfiz­er/BioN­Tech deal, which was spun from an­oth­er project the two com­pa­nies dis­cussed in 2020, be­fore the Covid-19 vac­cines were wide­ly avail­able, the part­ners said.

“We were in dis­cus­sions with Pfiz­er in the back half of 2020 on a sep­a­rate project and I think with­in Pfiz­er, word of mouth maybe just got around that the fit might be right to as­sist with the Covid project, it just blends well with our ex­per­tise in house,” busi­ness de­vel­op­ment leader Drew An­dis told End­points News. We do fo­cus on com­plex for­mu­la­tions with the large ma­jor­i­ty of our projects, fo­cus­ing specif­i­cal­ly on lipid nanopar­ti­cles, so I think they were able to rec­og­nize that we may be ca­pa­ble, we en­tered the turn of the year and we hit the ground run­ning.”

“We are ex­treme­ly proud to be part of the man­u­fac­ture of the Pfiz­er-BioN­Tech COVID-19 Vac­cine, know­ing our work has the po­ten­tial to help mil­lions of peo­ple,” Ex­e­lead CEO John Rigg said in a state­ment.

John Rigg

When the pan­dem­ic first be­gan, the com­pa­ny wor­ried about how it would af­fect the sup­ply chain. Soon af­ter, An­dis said, Ex­e­lead start­ed to re­al­ize that the emerg­ing tech­nol­o­gy used in Pfiz­er, Mod­er­na and Cure­Vac’s vac­cines was lipid nanopar­ti­cles. The CD­MO un­der­stood im­me­di­ate­ly there was an op­por­tu­ni­ty to help jump in pro­duc­ing those key de­liv­ery ve­hi­cles.

Ex­e­lead an­nounced in Oc­to­ber 2019 that it was go­ing to dou­ble its ca­pac­i­ty through a $25 mil­lion project at its In­di­ana lo­ca­tion be­fore Covid-19 was even on the radar. The com­pa­ny cit­ed a ris­ing de­mand for li­po­so­mal drug prod­ucts, and in a 2019 in­ter­view with In­side In­di­ana Busi­ness, Rigg said his com­pa­ny had to shut down op­er­a­tions for three months be­cause they had met their max­i­mum pro­duc­tion ca­pac­i­ty.

“I get a phone call once a week ask­ing if they can buy [Ex­e­lead],” Rigg said at the time. “It’s very, very hot in the ven­ture cap­i­tal world right now. A lot of our clients that we deal with are ven­ture cap­i­tal-backed.”

Ex­e­lead start­ed pro­duc­tion to­ward the end of May and has about 1 mil­lion dos­es com­plet­ed, the In­di­anapo­lis Fox af­fil­i­ate re­port­ed. The agree­ment will end at the end of 2021, when the two sides will then re-eval­u­ate.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,500+ biopharma pros reading Endpoints daily — and it's free.

As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

Endpoints Premium

Premium subscription required

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