WuXi officially opens cell and gene therapy site in Philly; Another massive manufacturing site comes to NC

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.

‘WuXi ATU has al­ways been at the fore­front of in­no­va­tion in Philadel­phia,’ said Kate Mc­Na­ma­ra, the SVP of the Philadel­phia In­dus­tri­al De­vel­op­ment Cor­po­ra­tion, Naval Yard site. ‘We are thrilled to cel­e­brate their con­tin­ued ex­pan­sion and growth with the open­ing of the new ad­vanced ther­a­pies test­ing fa­cil­i­ty at the Navy Yard.’

An­oth­er mas­sive man­u­fac­tur­ing site comes to NC

The Alexan­dria Re­al Es­tate group an­nounced that it will make a push to bring R&D and ‘next-gen man­u­fac­tur­ing’ to North Car­oli­na’s Re­search Tri­an­gle through part­ner­ships with top-tier biotechs through a se­ries of ac­qui­si­tions.

Most no­tably, the com­pa­ny bought up a 95 acre par­cel on Corn­wal­lis Road to build the Alexan­dria Cen­ter for NextGen Med­i­cines, and is in the per­mit­ting phase for a 125,000-square-foot site.

‘We en­tered the Re­search Tri­an­gle mar­ket in 1998, we are in­cred­i­bly proud to­day of our po­si­tion at the van­guard of the life sci­ence ecosys­tem that is lead­ing the in­te­gra­tion of R&D with next-gen man­u­fac­tur­ing for com­plex med­i­cines.’ said founder Joel Mar­cus. ‘Through Alexan­dria’s mis­sion-crit­i­cal in­fra­struc­ture, we are en­abling rev­o­lu­tion­ary gene ther­a­py com­pa­nies to pro­duce their med­i­cines in-house and there­by in­crease their con­trol over their qual­i­ty, sup­ply chains and tal­ent with­in the Unit­ed States.’

With the sale of Flori­da site, Ar­ran­ta fo­cus­es mR­NA pro­duc­tion in MA

Mass­a­chu­setts CD­MO Ar­ran­ta Bio has com­plet­ed the sale of a GMP clin­i­cal man­u­fac­tur­ing site in Gainesville, FL, and trans­ferred its client pro­grams and key em­ploy­ees to the Wa­ter­town fa­cil­i­ty, the com­pa­ny said Mon­day.

In­cep­tor Bio is the new own­er of the site about four miles north of the Uni­ver­si­ty of Flori­da cam­pus. The Wa­ter­town site will now have more than 160 em­ploy­ees fo­cused on sup­port­ing mi­cro­bio­me clients, man­u­fac­tur­ing crit­i­cal start­ing ma­te­ri­als and es­tab­lish­ing mR­NA vac­cine ca­pa­bil­i­ties. Its al­so prgress­ing its end-to-end mR­NA ca­pa­bil­i­ties, and will launch a ro­bot­ic ster­ile fill line by the end of Q2 2o22.

‘We are de­light­ed that In­cep­tor Bio will build on the foun­da­tion that we es­tab­lished in Gainesville and wish them every suc­cess in de­vel­op­ing life-sav­ing cell ther­a­py prod­ucts,’ CEO Mark Bam­forth said in a press re­lease. ‘And we are thrilled to con­tin­ue to build and ex­pand Ar­ran­ta’s com­mer­cial-ready man­u­fac­tur­ing team in Mass­a­chu­setts, the glob­al hub for bio­sciences.’

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.

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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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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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.

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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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.

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.

The House Energy & Commerce Committee began marking up a dozen bills on Wednesday morning including one that would require the FDA to craft a five-year action plan for fostering the development of drugs that improve or extend the lives of people living with rare neurodegenerative diseases.

Rare neurodegenerative diseases, like amyotrophic lateral sclerosis or ALS, have been historically very difficult to treat. But this bipartisan bill, introduced by Rep. Mike Quigley (D-IL), will provide $100 million for each of fiscal years 2022 through 2026 to help HHS award grants to facilitate access to investigational drugs that diagnose or treat ALS.
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