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.”

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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With on­ly burns to show in gene ther­a­py, Astel­las inks deal with AAV spe­cial­ist Dyno in push for a bet­ter cap­sid

On the hunt for a better AAV capsid for gene therapy, Eric Kelsic’s Dyno Therapeutics has set itself apart with its focus on machine learning to help speed discovery. Now, Japanese drugmaker Astellas — fresh off a slate of gene therapy burns — is taking a bet on Dyno as it looks to the future.

Astellas and Dyno will work together as part of an R&D pact to develop next-gen AAV vectors for gene therapy using Dyno’s CapsidMap platform directed at skeletal and cardiac muscle, the companies said Wednesday. Under the terms of the deal, Dyno will design AAV capsids for gene therapy, while Astellas will be responsible for conducting preclinical, clinical and commercialization activities for gene therapy product candidates using the capsids.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

Sanofi snaps up new vac­cine can­di­date and de­vis­es mR­NA game plan around it — but not for what you think

Paul Hudson has spotlighted vaccines, immunology and dermatology as some of the top R&D focuses at Sanofi. His latest deal brings all of them together.

The French pharma giant isn’t sharing any financial details about the buyout of Origimm, a low-profile, private Austrian biotech whose technology promises to identify antigens causing skin disease and build vaccines against them. Their lead candidate targets acne vulgaris.

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As first Omi­cron case in US crops up, re­searchers won­der: which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

Can South Dako­ta's trans­genic cows help treat the flu?; A speedy re­view for Mer­ck­'s Pre­vnar ri­val in kids

Wednesday brought another win for South Dakota’s biggest transgenic cow so far.

SAB Biotherapeutics, which develops treatments by collecting and distilling antibodies from cows with humanized immune systems, announced that its antibody treatment for flu passed an early-stage challenge study.

Volunteers were intentionally exposed to the flu virus and then given infusions of the SAB antibody treatment or placebo. Those who received the antibody treatment saw a significantly greater reduction in viral load and symptoms than those who received placebo. The company didn’t release numbers but said the p-value was 0.026.

Mod­er­na los­es lat­est bat­tle in key vac­cine de­liv­ery patent fight as fed­er­al ap­peal falls flat

The US Court of Appeals for the Federal Circuit on Wednesday rejected Moderna’s attempt to overturn key patents related to the delivery vehicle for its Covid-19 vaccine after the biotech sought to preempt a potentially risky infringement lawsuit.

For years, Moderna has been battling a tiny Pennsylvania biotech known as Arbutus over patents for a technology required to deliver its mRNA drugs and vaccines, known as lipid nanoparticles or LNP. Moderna is concerned there’s a substantial risk that Arbutus will assert the ’069 patent in an infringement suit targeting Moderna’s Covid-19 vaccine, particularly as Arbutus has boasted of its patent protection and refused to grant a covenant not to sue Moderna.

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