News brief­ing: Pre­ci­sion Med­i­cine Group ac­quires cell and gene ther­a­py-fo­cused ser­vices firm Pro­ject Far­ma; Roost­er­Bio and Sar­to­rius col­lab on gene ther­a­py man­u­fac­tur­ing

As more and more play­ers pur­sue cell and gene ther­a­pies, com­pa­nies are look­ing for ways to keep up on the man­u­fac­tur­ing end.

On Thurs­day, Pre­ci­sion Med­i­cine Group took the wraps off a deal to buy out Pro­ject Far­ma, a bio­engi­neer­ing ser­vices firm that sup­ports the man­u­fac­tur­ing and scale-up of cell and gene ther­a­pies. Pro­ject Far­ma will join Pre­ci­sion for Med­i­cine, PMG’s re­search and de­vel­op­ment ser­vices arm.

“The ac­qui­si­tion adds Pro­ject Far­ma’s unique ex­per­tise to Pre­ci­sion’s suite of end-to-end cell and gene ther­a­py ca­pa­bil­i­ties to sup­port de­vel­op­ment and com­mer­cial­iza­tion,” Pre­ci­sion said in a state­ment.

Pre­ci­sion was formed in 2012 as a spe­cial­ized ser­vices com­pa­ny sup­port­ing drug de­vel­op­ment and com­mer­cial­iza­tion. Since 2013, it has sup­port­ed over 70% of FDA-ap­proved cell and gene ther­a­pies, ac­cord­ing to CEO Mark Clein. The ad­di­tion of Pro­ject Far­ma will give Pre­ci­sion “true end-to-end ca­pa­bil­i­ties in cell and gene ther­a­py,” Clein said.

“In to­day’s high­ly com­pet­i­tive and scru­ti­nized ad­vanced ther­a­pies mar­ket­place, en­sur­ing a safe, scal­able, and high-qual­i­ty man­u­fac­tur­ing ca­pa­bil­i­ty can be the dif­fer­ence be­tween suc­cess and fail­ure,” Pre­ci­sion for Med­i­cine pres­i­dent Chad Clark said. —  Nicole De­Feud­is

Roost­er­Bio and Sar­to­rius to scale up cell and gene ther­a­py man­u­fac­tur­ing ca­pa­bil­i­ties

Roost­er­Bio and Sar­to­rius are team­ing up to boost cell and gene ther­a­py man­u­fac­tur­ing.

The com­pa­nies an­nounced the move Thurs­day, with the goal of ad­vanc­ing the scale-up of hu­man mes­enchy­mal stem/stro­mal cell man­u­fac­tur­ing for re­gen­er­a­tive med­i­cine. By do­ing so, process de­vel­op­ment ef­forts will be re­duced, sup­ply chains will be bol­stered and the de­vel­op­ment of the ther­a­pies them­selves will be ac­cel­er­at­ed, they said.

“Tak­ing hM­SC man­u­fac­tur­ing to the thou­sand-liter scale is crit­i­cal in meet­ing prod­uct dose re­quire­ments in com­mer­cial man­u­fac­tur­ing,” said Roost­er­Bio CEO Mar­got Con­nor in a state­ment.

Roost­er­Bio owns a se­ries of hM­SC work­ing cell banks, and the col­lab­o­ra­tion will aim to pair these banks and its cor­re­spond­ing pro­cess­ing sys­tems with Sar­to­rius’ sin­gle-use man­u­fac­tur­ing tech­nolo­gies. Sar­to­rius’s scal­able biore­ac­tors will then be used to scale up to 50 liters as part of this col­lab­o­ra­tion, with the sys­tem able to scale fur­ther to up to 2000 liters. — Max Gel­man

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Pfiz­er's big block­buster Xel­janz flunks its post-mar­ket­ing safe­ty study, re­new­ing harsh ques­tions for JAK class

When the FDA approved Pfizer’s JAK inhibitor Xeljanz for rheumatoid arthritis in 2012, they slapped on a black box warning for a laundry list of adverse events and required the New York drugmaker to run a long-term safety study.

That study has since become a consistent headache for Pfizer and their blockbuster molecule. Last year, Pfizer dropped the entire high dose cohort after an independent monitoring board found more patients died in that group than in the low dose arm or a control arm of patients who received one of two TNF inhibitors, Enbrel or Humira.

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Covid-19 roundup: EU and As­traZeneca trade blows over slow­downs; Un­usu­al unions pop up to test an­ti­bod­ies, vac­cines

After coming under fire for manufacturing delays last week, AstraZeneca’s feud with the European Union has spilled into the open.

The bloc accused the pharma giant on Wednesday of pulling out of a meeting to discuss cuts to its vaccine supplies, the AP reported. AstraZeneca denied the reports, saying it still planned on attending the discussion.

Early Wednesday, an EU Commission spokeswoman said that “the representative of AstraZeneca had announced this morning, had informed us this morning that their participation is not confirmed, is not happening.” But an AstraZeneca spokesperson later called the reports “not accurate.”

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Adeno-associated virus-1 illustration; the use of AAVs resurrected the gene therapy field, but companies are now testing the limits of a 20-year-old technology (File photo, Shutterstock)

Af­ter 3 deaths rock the field, gene ther­a­py re­searchers con­tem­plate AAV's fu­ture

Nicole Paulk was scrolling through her phone in bed early one morning in June when an email from a colleague jolted her awake. It was an article: Two patients in an Audentes gene therapy trial had died, grinding the study to a halt.

Paulk, who runs a gene therapy lab at the University of California, San Francisco, had planned to spend the day listening to talks at the American Association for Cancer Research annual meeting, which was taking place that week. Instead, she skipped the conference, canceled every work call on her calendar and began phoning colleagues across academia and industry, trying to figure out what happened and why. All the while, a single name hung in the back of her head.

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Bomb squad called to As­traZeneca vac­cine plant; Lu­men nabs CARB-X award for low-cost an­tidiar­rheal

A plant located in Wrexham, Wales that is packing the Oxford/AstraZeneca Covid-19 vaccine into vials was surrounded by a bomb squad after officials called police to report a suspicious package.

The alert caused a partial evacuation of the plant, the BBC was among those to report Wednesday. The owner of the plant, British drugmaker Wockhardt UK, said it was cooperating with local authorities and that there were no reports of any injuries.

Pascal Soriot, AP

As­traZeneca CEO Pas­cal So­ri­ot sev­ers an un­usu­al board con­nec­tion, steer­ing clear of con­flicts while re­tain­ing im­por­tant al­liances

CSL Behring chief Paul Perreault scored an unusual coup last summer when he added AstraZeneca CEO Pascal Soriot to the board, via Zoom. It’s rare, to say the least, to see a Big Pharma CEO take any board post in an industry where interests can simultaneously connect and collide on multiple levels of operations.

The tie set the stage for an important manufacturing connection. The Australian pharma giant agreed to supply the country with 10s of millions of AstraZeneca’s Covid-19 vaccine, once it passes regulatory muster.

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Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Anthony Fauci, NIAID director (AP Images)

As new Covid-19 task force gets un­der­way, threat looms of vac­cine, mon­o­clon­al an­ti­body-re­sis­tant vari­ants

Hours before President Biden’s Covid-19 team gave their first virtual press conference, the famed AIDS researcher David Ho delivered concerning news in a new pre-print: SARS-CoV-2 B.1.351, the variant that emerged in South Africa, is “markedly more resistant” to antibodies from convalescent plasma and vaccinated individuals.

The news for several monoclonal antibodies, including Eli Lilly’s bamlanivimab, was even worse: Their ability to neutralize was “completely or markedly abolished,” Ho wrote. Lilly’s antibody cocktail, which was just shown to dramatically reduce the risk of hospitalizations or death, also became far less potent.

Jackie Fouse, Agios CEO

Agios scores its sec­ond pos­i­tive round of da­ta for its lead pipeline drug — but that won't an­swer the stub­born ques­tions that sur­round this pro­gram

Agios $AGIO bet the farm on its PKR activator drug mitapivat when it recently decided to sell off its pioneering cancer drug Tibsovo and go back to being a development-stage company — for what CEO Jackie Fouse hoped would be a short stretch before they got back into commercialization.

On Tuesday evening, the bellwether biotech flashed more positive topline data — this time from a small group of patients in a single-arm study. And the executive team plans to package this with its earlier positive results from a controlled study to make its case for a quick OK.

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