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.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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