David Chang, WuXi AppTec

A 'love sto­ry': WuXi AppTec wraps UK-based CRO in­to its cell and gene ther­a­py unit

When WuXi AppTec, one of Chi­na’s largest con­tract re­search or­ga­ni­za­tions, start­ed work­ing with UK-based Ox­gene about a year ago, it was “love at first sight,” CEO David Chang jokes.

Ox­gene, a rough­ly decade-old CRO fo­cused on scal­able gene ther­a­py tech, be­gan li­cens­ing some of their plas­mid work to WuXi just over a year ago. And when that pi­lot went well, WuXi ex­pressed in­ter­est in in­vest­ing, Ox­gene CEO Ryan Ca­wood said.

“As con­ver­sa­tions pro­gressed and we re­al­ized there were very strong syn­er­gies be­tween the two com­pa­nies, we just re­al­ized that this just made sense,” Ca­wood said.

Ryan Ca­wood

On Tues­day morn­ing, the com­pa­nies took the wraps off a $135 mil­lion ac­qui­si­tion deal. Ox­gene will keep its name, but be­come a sub­sidiary in WuXi’s cell and gene ther­a­py-cen­tered Ad­vanced Ther­a­pies Unit (ATU).

“I call that the last piece of the puz­zle,” Chang said.

Chi­na’s cost ad­van­tage and po­si­tion as the world’s sec­ond-largest pre­scrip­tion drug mar­ket has fu­eled its red-hot CRO in­dus­try over the last few years. WuXi AppTec’s ATU unit, which be­came a le­gal en­ti­ty just last year, prides it­self as a “one turnkey so­lu­tion,” Chang said — a one-stop-shop for cell and gene ther­a­py test­ing, man­u­fac­tur­ing and de­vel­op­ment.

The miss­ing puz­zle piece, though, was next-gen gene ther­a­py man­u­fac­tur­ing tech. When WuXi be­gan li­cens­ing Ox­gene’s AAV and lentivi­ral plas­ma tech­nol­o­gy, they al­ready had some tech in-li­censed from oth­ers. But the per­for­mance was “just mediocre,” Chang said.

“The out­come … is an or­der of mag­ni­tude bet­ter than what­ev­er we had seen in the mar­ket a year ago,” he said of Ox­gene’s prod­ucts.

Ox­gene will al­so be chris­tened as WuXi ATU’s first Eu­ro­pean fa­cil­i­ty, thus ex­pand­ing their glob­al pres­ence. The ATU head­quar­ters are in Philadel­phia, and the unit al­so boasts a Chi­nese fa­cil­i­ty.

In terms of mak­ing gene ther­a­pies, Ox­gene is look­ing to shake up the cur­rent in­dus­try stan­dard, which is plas­mid trans­fec­tion — the mech­a­nism of adding a DNA plas­mid to a cell.

“If you’re us­ing trans­fec­tion as your process you are in­her­ent­ly lim­it­ed in terms of scal­a­bil­i­ty, and in terms of the cost of goods they’re al­ways go­ing to be very very high,” Ca­wood said. “So we ba­si­cal­ly want to throw trans­fec­tion out the win­dow, even­tu­al­ly over the next cou­ple of years, and re­place it with new and im­proved tech­nolo­gies.”

On the lentivi­ral side, the CRO is cre­at­ing “sta­ble cell lines,” where all the com­po­nents you would nor­mal­ly have in a plas­mid are in­te­grat­ed in­to a cell line, thus re­mov­ing the need for plas­mids, Ca­wood ex­plained. On the AAV side, they’ve es­sen­tial­ly re­pur­posed ade­n­ovirus to de­liv­er the ge­net­ic com­po­nents of AAV in­to a cell — a tech­nol­o­gy they call TES­SA.

“That plat­form al­lows you to in­fect at very high cell den­si­ties, it al­lows you to pro­duce very large quan­ti­ties of AAV, and a com­plete­ly trans­fec­tion-free process,” Ca­wood said.

The Ox­gene team is al­so work­ing on a “se­ries of oth­er tech­nolo­gies” be­hind the scenes, and plans on fil­ing three new patents in the next two weeks.

Ox­gene is get­ting a sin­gle cash trans­ac­tion of $135 mil­lion, plus the chance to ramp up man­u­fac­tur­ing ca­pa­bil­i­ties, which is some­thing they were al­ready look­ing to do, Ca­wood said.

“I tru­ly be­lieve that we’re trans­form­ing the fu­ture, the vi­ral vec­tor pro­duc­tion, and we all know by now it’s cur­rent­ly a bot­tle­neck for the gene ther­a­py in­dus­try,” Chang said.

Qual­i­ty Con­trol in Cell and Gene Ther­a­py – What’s Re­al­ly at Stake?

In early 2021, Bluebird Bio was forced to suspend clinical trials of its gene therapy for sickle cell disease after two patients in the trial developed cancer. As company scientists rushed to assess whether there was any causal link between the therapy and the cancer cases, Bluebird’s stock value plummeted – as did those of multiple other biopharma companies developing similar therapies.

While investigations concluded that the gene therapy was unlikely to have caused cancer, investors and the public may be more skittish regarding the safety of gene and cell therapies after this episode. This recent example highlights how delicate the fields of cell and gene therapy remain today, even as they show great promise.

Law pro­fes­sors call for FDA to dis­close all safe­ty and ef­fi­ca­cy da­ta for drugs

Back in early 2018 when Scott Gottlieb led the FDA, there was a moment when the agency seemed poised to release redacted complete response letters and other previously undisclosed data. But that initiative never gained steam.

Now, a growing chorus of researchers are finding that a dearth of public data on clinical trials and pharmaceuticals means industry and the FDA cannot be held accountable, two law professors from Yale and New York University write in an article published Wednesday in the California Law Review.

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Novavax CEO Stanley Erck at the White House in 2020 (Andrew Harnik, AP Images)

As fears mount over J&J and As­traZeneca, No­vavax en­ters a shaky spot­light

As concerns rise around the J&J and AstraZeneca vaccines, global attention is increasingly turning to the little, 33-year-old, productless, bankruptcy-flirting biotech that could: Novavax.

In the now 16-month race to develop and deploy Covid-19 vaccines, Novavax has at times seemed like the pandemic’s most unsuspecting frontrunner and at times like an overhyped also-ran. Although they started the pandemic with only enough cash to last 6 months, they leveraged old connections and believers into $2 billion and emerged last summer with data experts said surpassed Pfizer and Moderna. They unveiled plans to quickly scale to 2 billion doses. Then they couldn’t even make enough material to run their US trial and watched four other companies beat them to the finish line.

FDA of­fers scathing re­view of Emer­gent plan­t's san­i­tary con­di­tions, em­ploy­ee train­ing af­ter halt­ing pro­duc­tion

The FDA wrapped up its inspection of Emergent’s troubled vaccine manufacturing plant in Baltimore on Tuesday, after halting production there on Monday. By Wednesday morning, the agency already released a series of scathing observations on the cross contamination, sanitary issues and lack of staff training that caused the contract manufacturer to dispose of millions of AstraZeneca and J&J vaccine doses.

Brad Bolzon (Versant)

Ver­sant pulls the wraps off of near­ly $1B in 3 new funds out to build the next fleet of biotech star­tups. And this new gen­er­a­tion is built for speed

Brad Bolzon has an apology to offer by way of introducing a set of 3 new funds that together pack a $950 million wallop in new biotech creation and growth.

“I want to apologize,” says the Versant chairman and managing partner, laughing a little in the intro, “that we don’t have anything fancy or flashy to tell you about our new fund. Same team, around the same amount of capital, same investment strategy. If it ain’t broke, don’t fix it.”

But then there’s the flip side, where everything has changed. Or at least speeded into a relative blur. Here’s Bolzon:

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Werner Lanthaler, Evotec CEO

Evotec strength­ens its French con­nec­tion, pledg­ing to drop $120M in­to Toulouse plant for Covid-19 an­ti­bod­ies

Much of the recent focus on manufacturing capacity for Covid-19 has been on vaccines, and for good reason, too. But countries are also hoping to build a big enough footprint to produce pandemic-level monoclonal antibodies, and now France is working with Germany’s Evotec to stay prepared.

Evotec will lay out $120 million with a $60 million boost from multiple French governments and investors to build a new biologics facility in Toulouse that will expand its capacity to produce therapeutic antibodies for Covid-19, the German CDMO and biotech said this week.

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Why re­mote drug man­u­fac­tur­ing eval­u­a­tions won't re­al­ly re­duce FDA's back­log of in­spec­tions

For the first several months of the pandemic last spring, the FDA continued to plow through its user fee-enabled work on new drug and biologic applications, meeting nearly all of its goal dates.

But by last fall and into the winter, complete response letters and other delays began arriving in companies’ mailboxes as the agency struggled to catch up to a growing backlog of both domestic and foreign drug manufacturing inspections.

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House Committee on Oversight and Reform Chairwoman Carolyn Maloney (Getty Images)

House De­moc­rats call on Emer­gent ex­ecs to tes­ti­fy on qual­i­ty is­sues next month

The House Oversight Committee is investigating Covid-19 vaccine producer Emergent BioSolutions, which secured a $628 million US government contract to make AstraZeneca and J&J vaccines despite “a long, documented history” of quality control issues, Democrats said in a letter to the contract manufacturer’s executives.

Emergent’s Baltimore plant, which was shuttered on Monday by FDA, has been embroiled in controversy after being forced to destroy millions of AstraZeneca and J&J doses due to an ingredient mix-up and possible contamination.

JP Gabriel, Ocugen

JP Gabriel watched from the bleach­ers as the pan­dem­ic raged. Now head of sup­ply chain at Ocu­gen, he's ready to bat

The world was in the middle of the most pressing public health risk his generation had ever seen, and JP Gabriel felt like he was sitting on the sidelines. As a VP of biologics and mRNA manufacturing at Ultragenyx, Gabriel watched from the sidelines as players like Pfizer/BioNTech and Moderna used mRNA tech to chase their own Covid-19 vaccines.

This month, Gabriel got the chance to get his hands dirty against the pandemic — but it won’t be with mRNA.

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