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.

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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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase 3 trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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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.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.