South Korean drugmaker SK looks to take over Philly CDMO’s operations

The hold­ing com­pa­ny of a South Ko­re­an vac­cine mak­er is in the fi­nal talks to make an in­vest­ment in­to a US gene ther­a­py firm.

SK Bio­sciences is in the process of sign­ing a deal with the Cen­ter for Break­through Med­i­cines (CBM), a Philadel­phia-based CD­MO. If fi­nal­ized, the deal will come eight months af­ter SK’s takeover of the French gene and cell ther­a­py com­pa­ny Yposke­si.

With this move, SK takes it­self a step clos­er to es­tab­lish­ing a val­ue chain of syn­thet­ic and bio phar­ma­ceu­ti­cals in the US, Eu­rope and Asia by 2025, the com­pa­ny’s head of the in­vest­ment cen­ter Lee Dong-hoon said in a pre­sen­ta­tion. The CBM is known for its pro­duc­tion of plas­mid DNA. With SK’s in­vest­ment, it will ex­pand man­u­fac­tur­ing fa­cil­i­ty in the Cel­li­con Val­ley cell and gene ther­a­py clus­ter by 699,654 square feet.

That project will be com­plet­ed by 2025, The Ko­rea Her­ald says.

CBM was es­tab­lished in 2019 and of­fers ful­ly-in­te­grat­ed pre-clin­i­cal through com­mer­cial man­u­fac­tur­ing ca­pa­bil­i­ties that in­clude process de­vel­op­ment, plas­mid DNA, and vi­ral vec­tor man­u­fac­tur­ing, cell bank­ing, cell pro­cess­ing, and a full suite of test­ing and an­a­lyt­ic ca­pa­bil­i­ties. The fi­nanc­ing is set to close in De­cem­ber.

‘We are thrilled by the op­por­tu­ni­ty to join forces with SK Inc., the per­fect strate­gic part­ner to en­able CBM’s core mis­sion of ex­pe­dit­ing the path to ap­proval for cell and gene ther­a­pies for pa­tients in need,’ said co-founder of CBM Au­drey Green­berg in a press re­lease. ‘SK’s mis­sion of de­liv­er­ing val­ue and hap­pi­ness for all, cul­ture of safe­ty and qual­i­ty, em­pha­sis on ESG val­ues, and glob­al reach cre­ates an ide­al match for CBM. SK has a strong bio­phar­ma port­fo­lio, in­clud­ing con­sid­er­able in­vest­ments in cell & gene ther­a­py com­pa­nies cre­at­ing enor­mous strate­gic val­ue for CBM.  The SK CBM part­ner­ship will bring ca­pac­i­ty to a starved CGT mar­ket­place and ex­pe­dite the de­liv­ery of new ther­a­pies to pa­tients who need them now.’

SK ex­pand­ed its vac­cine pro­duc­tion in a big way over the sum­mer, af­ter it an­nounced it would in­vest $132 mil­lion in pro­duc­tion ca­pac­i­ty in mR­NA and vi­ral vec­tor op­er­a­tions in a project set to be op­er­a­tional by 2024. That ex­pan­sion will add more than 1 mil­lion square feet of pro­duc­tion space in An­dong, and was the first site in the coun­try to get the OK for Covid-19 vac­cine man­u­fac­tur­ing on the con­ti­nent.

It al­so re­ceived back­ing from CEPI, a coali­tion that backed both Mod­er­na and Ox­ford, and with it, $173.4 mil­lion to fin­ish its clin­i­cal tri­als and scale up man­u­fac­tur­ing to work on a vac­cine that de­liv­ers at low dos­es.

For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.

Thermo Fisher CEO Mark Casper

Another week, another win for the North Carolina biotech community.

This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.

The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.

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Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)

Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.

This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.

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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.

The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.

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A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.

The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.

The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.

Endo International is expanding its manufacturing capacity at a subsidiary to help out the US national stockpile, and it’s getting funding from the government to do so.

Par Sterile Products will expand the sterile fill-finish capacity at a Rochester, MI site to up the defense efforts against future pandemics. The company will establish a new line that’s fit with the capability of processing liquid or lyophilized products that require Biosafety Level 2 containment. It will also provided inspection and packaging capacity, and the government will fund the majority of the project — $90 million of the $120 million total cost.

Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO

A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.

Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.

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Sree Kant, BAKX Therapeutics CEO

BAKX Therapeutics emerged from stealth in a big way back in July, striking an $852 million deal with Ipsen for its lead cancer candidate, a small molecule designed to activate the body’s natural process for programmed cell death. And Ipsen’s putting a bit more cash in the company’s coffers to see that program into the clinic.

CEO Sree Kant unveiled a $25 million Series A round on Thursday, led by AB Magnitude Ventures Group with a hand from Ipsen and Sherpa Healthcare Partners. The funds will be used to advance the company’s BAKX activator program, which traces back to pioneering work around apoptosis by the Dana-Farber Cancer Institute’s Loren Walensky and Albert Einstein College of Medicine’s Evripidis Gavathiotis.

J&J and AbbVie are competing for the same Crohn’s disease market with their respective IL-23 drugs, Tremfya and Skyrizi. On Wednesday, J&J’s Janssen unit revealed data it thinks could prove a key differentiator but appears to lack key context.

In long-term, Phase II follow-up data stretching to 48 weeks, 65% of patients taking Tremfya saw their Crohn’s disease enter clinical remission, J&J announced. The company did not say what proportion of patients hit remission in the placebo group, however, saying researchers didn’t measure for comparison to placebo after week 12.
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