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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Eisai and METAvivor plan to debut the latest 'This is MBC' campaign at the San Antonio Breast Cancer Symposium (SABCS).

Ei­sai re-ups metasta­t­ic breast can­cer aware­ness cam­paign with strik­ing pa­tient pho­tographs

Eisai is debuting the newest ads in its long-running “This is MBC” campaign this week. In what’s become an annual tradition, Eisai and metastatic breast cancer advocacy partner METAvivor will show the striking photographs of people living with metastatic breast cancer first at the San Antonio Breast Cancer Symposium (SABCS).

The new “Imagine” campaign features 12 patients photographed around waterfalls to symbolize that same kind of sudden drop into a pool that MBC causes in a person’s life, said Beth Fairchild, co-founder of #CancerCulture who was the president of METAvivor six years ago when the campaign began. Fairchild, who is living with MBC, has helped create all of the annual “This is MBC” campaigns.

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Pfiz­er and BioN­Tech look to toss Mod­er­na patent suit, call­ing claims 'unen­force­able'

Pfizer and BioNTech took a swing at Moderna’s Covid-19 patent claims in Massachusetts federal court on Monday, calling them “invalid,” “overbroad” and “unenforceable.”

The defendants also filed counterclaims against the Cambridge, MA-based biotech, seeking a dismissal of the case, recovery of court fees and an official judgment invalidating Moderna’s claims.

Moderna sued Pfizer and BioNTech back in August, alleging that the partners’ Covid-19 vaccine Comirnaty copied parts of Moderna’s vaccine technology patented before the pandemic, when it was developing an mRNA vaccine for MERS, another respiratory illness.

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Sum­i­to­vant sub­sidiaries En­zy­vant and Al­ta­vant merge in­to com­bined com­pa­ny

Two Sumitovant Biopharma entities are merging under one name, effective immediately.

Enzyvant Therapeutics and Altavant Sciences announced they have merged to form a singular entity focused on developing therapies for patients with rare diseases. The combined company will keep the name Enzyvant and along with clinical development will eventually include in-house manufacturing.

Bill Symonds, the current CEO of both Altavant and Enzyvant, is now CEO of the merged company.

Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Bob Duggan, Summit Therapeutics co-CEO

Bounc­ing from ma­jor set­back, Sum­mit hands out $500M cash for can­cer drug — thanks to a loan from bil­lion­aire CEO

After hitting a dead end with Summit Therapeutics’ lead program, Bob Duggan has found the drug that he believes will usher into a compelling second act. So compelling, in fact, that it involves $500 million cash — and he’s taking money out of his own pocket to fund the deal.

Striking a partnership with Akeso Therapeutics out of China, Summit is bringing in a bispecific antibody that blocks both PD-1 and VEGF called ivonescimab. Akeso, which has a PD-1/CTLA-4 bispecific approved in China, has already taken ivonescimab into multiple clinical trials, including a Phase III in lung cancer.

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Glen­mark hit with warn­ing let­ter over pro­ce­dures, qual­i­ty con­trol is­sues at In­dia man­u­fac­tur­ing plant

The generics producer Glenmark Pharmaceuticals has been handed a warning letter by US regulators.

The letter, which was sent to the manufacturer on Nov. 22, noted issues from an inspection over the summer at Glenmark’s facility in the town of Colvale, India, in the state of Goa.

According to the letter, the FDA found that Glenmark’s investigation of rejected batches of drugs “failed to extend to other batches, dosage strengths, and drug products.” The warning letter also noted that the site had failed to establish “adequate written procedures” for production and process control to ensure drugs have the correct strength, quality and purity.

Klick Health is lighting the way, literally, this holiday season to encourage connection for lonely seniors in long-term care facilities.

Klick Health an­nu­al hol­i­day spot­light se­nior lone­li­ness and the pow­er of con­nec­tion

Every year Klick Health leans into a cause for the holidays, and this year it’s highlighting the sometimes lonely season for seniors. So Klicksters, as employees call themselves, decided to brighten one nursing home community in hopes of inspiring others to do the same.

Klick literally lit up the Tony Stacey Centre for Veterans Care, a long-term care home in Toronto where 75% of residents receive no visitors during the holiday season. The agency brought staff and family along with lighting crews and musicians for a “Light the Way” event, creating a video of the experience debuting on Tuesday.

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