Tim Harkness, Unchained Labs CEO

The Car­lyle Group shells out $435M for con­trol­ling stake in vac­cine, gene ther­a­py ser­vices com­pa­ny

The Car­lyle Group has put a tar­get on life sci­ences in re­cent years, look­ing for op­por­tu­ni­ties to take con­trol­ling stakes in promis­ing firms. Af­ter shelling out near­ly half-a-bil­lion dol­lars last year on a one-fifth stake in an In­di­an CD­MO, the DC in­vestors have their eyes set on a com­pa­ny spe­cial­iz­ing in vac­cine and gene ther­a­py ser­vices.

Car­lyle shelled out $435 mil­lion to ac­quire more than 90% of Un­chained Labs, a six-year-old Cal­i­for­nia-based firm, from Dan­ish as­set man­ag­er No­vo Hold­ings and VC firms TPG Biotech and Canaan Part­ners.

The com­pa­ny has 170 em­ploy­ees, and ex­pects to gen­er­ate $75 mil­lion in rev­enue this year, ac­cord­ing to a re­lease. In Oc­to­ber, Un­chained launched its gene ther­a­py tool Stun­ner, a plat­form de­signed to give re­searchers a speedy read­out on AAV cap­sid con­cen­tra­tion and vi­a­bil­i­ty. In Jan­u­ary, it launched a mR­NA vac­cine ap­pli­ca­tion on Stun­ner that mea­sures the size dis­tri­b­u­tion of lipid nanopar­ti­cles and the to­tal amount of mR­NA at the same time.

In a press re­lease, CEO Tim Hark­ness said:

The Un­chained team has solved a ton of prob­lems for re­searchers over the past few years, but we are just be­gin­ning to scratch the sur­face of the bi­o­log­ics and gene ther­a­py op­por­tu­ni­ty. I am thrilled to wel­come Car­lyle as our new part­ner! They have the team, the vi­sion, the con­vic­tion, the ex­pe­ri­ence, and the cap­i­tal to help us ac­cel­er­ate or­gan­ic and in­or­gan­ic growth and re­al­ize our full po­ten­tial. I have nev­er been more op­ti­mistic about our fu­ture and I am tru­ly ex­cit­ed about join­ing Car­lyle for the next part of our jour­ney.

Hark­ness did not re­spond to an in­ter­view re­quest by press time.

The com­pa­ny has grown by more than 30% year over year, ac­cord­ing to Car­lyle man­ag­ing di­rec­tor Robert Schmidt, and the in­vest­ment was made out of the $18.5 bil­lion Car­lyle Part­ners VII fund.

At the start of April, Un­chained an­nounced an­oth­er gene ther­a­py and vac­cine ap­pli­ca­tion dubbed Big Tu­na, that fo­cus­es on the buffer ex­change, con­cen­tra­tion and clean-up of AAVs and lipid nanopar­ti­cles.

Car­lyle bought 20% of CD­MO Pi­ra­mal back in the sum­mer of 2020, in a deal that brought $490 mil­lion in cash, and ac­quired a ma­jor­i­ty stake in health re­search net­work TriNetX. The com­pa­ny is lean­ing on Un­chained’s R&D and dig­i­ti­za­tion, and hint­ed at ex­pan­sion, as Schmidt said that they hope to ac­cel­er­ate the com­pa­ny’s “ag­gres­sive growth plans.”

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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Gene ther­a­py from Bio­gen's $800M buy­out flops in mid-stage study, deal­ing blow to new am­bi­tions

The #2 candidate from Biogen’s $800 million ocular gene therapy buyout has failed in a mid-stage trial, dealing an early blow to the big biotech’s plans to revitalize its pipeline with new technologies.

Biogen announced that the candidate, an experimental treatment for a rare and progressive form of blindness called X-linked retinitis pigmentosa (XLRP), failed to sufficiently improve vision in patients’ treated eye — patients only received an injection in one eye — after a year, on a standard scale, compared to their untreated eye. The company said they saw “positive trends” on several secondary endpoints, including visual acuity, but declined to say whether the trial actually hit any of those endpoints.

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Vas Narasimhan (Photographer: Simon Dawson/Bloomberg via Getty Images)

No­var­tis whiffs on En­tresto study af­ter heart at­tacks — but that does­n't mean it's go­ing down qui­et­ly

If Novartis learned one thing from its interaction with the FDA over its latest heart failure approval for Entresto, it was that missing a primary endpoint may not be the nail in the coffin. Now, Entresto has missed again on a late-stage study in high-risk heart patients, and it’s already sowing the seeds for a path forward regardless.

Novartis’ Entresto couldn’t best standard-of-care ramipril in staving off a composite of deaths and heart failure events in patients with left ventricular systolic dysfunction and/or pulmonary congestion who have had a prior heart attack, according to topline data from the Phase III PARADISE-MI study revealed Saturday at the virtual American College of Cardiology meeting.

Michael Dell (Richard Drew, AP Images)

'Dude, you're get­ting a Del­l' — as a new deep-pock­et biotech in­vestor

What happens when you marry longtime insiders in the global biotech VC game with the family fund of tech billionaire Michael Dell, a synthetic biology legend out of MIT and Harvard and the former director of the NCI?

Today, the answer is a newly financed, $200 million biotech SPAC now cruising the industry for a top player interested in finding a short cut to Nasdaq.

Orion Biotech Opportunities priced their blank check company today, raising $200 million with Dell’s multibillion-dollar MSD group’s commitment on investing another $20 million in a forward-purchase agreement.

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BAR­DA slows its $9B en­gine for new Covid-19 ther­a­peu­tics

The Biomedical Advanced Research and Development Authority is cooling its jets in looking for new, potential Covid-19 treatments, at least in the near term.

An HHS spokesperson told Endpoints News via email, “to date, BARDA has obligated more than $9 billion for the development and/or purchase of 13 therapeutics, beginning in February 2020 with support to develop Regeneron’s monoclonal antibody therapeutic. Therapeutics are an important element of the COVID-19 response, and we are focused on the programs currently underway and/or in negotiation using the funds available to us.”

Bris­tol My­ers backs up its case for heart drug mava­camten as FDA weighs app in car­diomy­opa­thy

When Bristol Myers Squibb signed off on its $13 billion acquisition of MyoKardia back in October, it was making a big bet that lead drug mavacamten could prove a game changer in cardiac myopathy. Now, with the drug up for FDA review, Bristol Myers is backing up its case with new quality of life data.

Patients dosed with myosin inhibitor mavacamten posted a clinically significant increase in scores on the Kansas City Cardiomyopathy Questionnaire, a catch-all summary of symptoms and quality of life markers, over placebo at 30 weeks, according to data from the Phase III EXPLORER-HCM study presented Saturday at the virtual American College of Cardiology meeting.

Prahlad Singh, PerkinElmer

PerkinElmer hits the check­book again, this time dol­ing out $260M for next-gen ther­a­py bioser­vices firm

When PerkinElmer iced a deal to pick up UK gene editing firm Horizon Discovery, it trumpeted its big move into next-gen therapeutics. Now, not content to sit on its laurels, PerkinElmer is dipping into the war chest again, this time for a firm specializing in cutting-edge bioservices.

Life sciences services giant PerkinElmer will shell out $260 million to acquire Lawrence, MA-based Nexcelom Bioscience, which offers clinical services for next-gen cell and gene therapies, immuno-oncology drugs and vaccines, the companies said Thursday.

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UP­DAT­ED: Apel­lis bags FDA nod for Soliris chal­lenger with a dif­fer­ent path­way to PNH — but can it slay the gi­ant?

With a blockbuster rare disease giant in its sights in Alexion’s Soliris, small biotech Apellis has reason to think its competitor is worthy of the spotlight. Now, with the FDA on its side, Apellis will get its chance to be the David to Alexion’s Goliath.

The FDA on Friday approved Empaveli (pegcetacoplan), a C3 complement inhibitor the biotech thinks can prove a worthy challenger to Alexion’s C5 inhibitors Soliris and follow-up drug Ultomiris in rare disease paroxysmal nocturnal hemoglobinuria (PNH).