With the ground bro­ken on a Van­cou­ver head­quar­ters, an­ti­body mak­er Ab­Cellera will add man­u­fac­tur­ing space next door

The Cana­di­an gov­ern­ment is look­ing to raise the pro­file of the coun­try’s na­tive biotech in­dus­try, and British Co­lum­bia’s Ab­Cellera is the lat­est com­pa­ny to ben­e­fit from the na­tion’s strate­gic in­no­va­tion fund.

Mur­ray Mc­Cutcheon

Ab­Cellera has land­ed a site in Van­cou­ver for a 130,000-square-foot fa­cil­i­ty to help bring the biotech’s an­ti­body ther­a­pies to clin­i­cal tri­als. In April, the com­pa­ny broke ground on a 380,000-square-foot head­quar­ters that will be with­in walk­ing dis­tance of the new man­u­fac­tur­ing fa­cil­i­ty, set to be built on a va­cant two-acre site.

Mur­ray Mc­Cutcheon, the VP of cor­po­rate de­vel­op­ment, said in a call to End­points News that the nov­el­ty of the site in Cana­da, cou­pled with the nat­ur­al beau­ty and the qual­i­ty of life that comes with liv­ing in British Co­lum­bia, will be a huge draw to new em­ploy­ees.

“We’re quite for­tu­nate here on the West Coast here to have great uni­ver­si­ties and have great tal­ent, but so far, we haven’t had a very big biotech ecosys­tem, and we’re work­ing to change that,” COO Véronique Lecault said Wednes­day.

Véronique Lecault

When the pan­dem­ic un­fold­ed, Ab­Cellera was forced to piv­ot quick­ly and went from dis­cov­ery to hu­man clin­i­cal tri­als with­in 90 days for its mon­o­clon­al an­ti­body ther­a­py bam­lanivimab, which was co-de­vel­oped with Eli Lil­ly to treat pa­tients by work­ing against spike pro­tein to re­duce vi­ral repli­ca­tion.

In April though, the FDA re­voked the emer­gency use au­tho­riza­tion for bam­lanivimab when ad­min­is­tered alone, as the in­crease in vari­ants be­came re­sis­tant to the drug and led to an in­crease in treat­ment fail­ure.

Ab­Cellera has dis­cov­ered a sec­ond an­ti­body, LY-CoV1404, that it is de­vel­op­ing with Lil­ly to help ad­dress vari­ants of Covid-19. The an­ti­body en­tered clin­i­cal tri­als in May.

The fa­cil­i­ty is set to be op­er­a­tional by 2024, and will em­ploy an ad­di­tion­al 300 peo­ple over the next few years. When asked, Mc­Cutcheon said that it is not yet clear which an­ti­bod­ies will be man­u­fac­tured at the site since it is still years away from com­ple­tion.

The Cana­di­an gov­ern­ment has thrown  $125.6 mil­lion from its SIF to sup­port the work, in ad­di­tion, to of­fer pre­pared­ness for fu­ture pan­demics.

François-Philippe Cham­pagne

“Al­though the Cana­di­an an­gle is an im­por­tant piece of it, be­cause the gov­ern­ment has pro­vid­ed us an im­por­tant fund­ing com­mit­ment, as a com­pa­ny, our part­ners are glob­al, our so­lu­tions are glob­al and the bor­der is ir­rel­e­vant we will make this avail­able to every­body we work with and ul­ti­mate­ly we think it will help us bring ther­a­pies to pa­tients faster,” Mc­Cutcheon said.

Re­silience, the Bob Nelsen project aimed at the lofty goal of rewrit­ing the rules of drug man­u­fac­tur­ing, al­so re­cent­ly struck a deal with the Cana­di­an Strate­gic In­no­va­tion Fund, which gave the com­pa­ny $163 mil­lion to ex­pand mR­NA pro­duc­tion at the com­pa­ny’s Mis­sis­sauga fa­cil­i­ty. Prime Min­is­ter Justin Trudeau said in a press con­fer­ence that the move was a step to­ward build­ing fu­ture pan­dem­ic pre­pared­ness, and boost­ing its pres­ence in the life sci­ences.

“I am pleased to see Ab­Cellera par­tic­i­pat­ing in our gov­ern­ment’s ef­fort to re­verse a four-decade de­cline in Cana­da’s do­mes­tic ca­pac­i­ty,” min­is­ter of in­no­va­tion, sci­ence and in­dus­try François-Philippe Cham­pagne said. “This is an im­por­tant step to­ward im­prov­ing Cana­da’s pan­dem­ic pre­pared­ness, and a dri­ver for our eco­nom­ic re­cov­ery.”

So­cial im­age: Carl Hansen, Ab­Cellera CEO

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Rahul Singhvi, Resilience CEO

Q&A: Re­silience boss Rahul Singhvi talks $2B US bio­man­u­fac­tur­ing ini­tia­tive and post Se­ries D deals

When the Biden administration announced last week, through an executive order, that it is investing $2 billion into domestic efforts to increase biotechnology and biomanufacturing efforts, a lot of ears perked up in the wider manufacturing world. Funding is going towards manufacturing infrastructure, training, R&D and security measures, among others, something that domestic manufacturers are bullish about.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

On Thursday evening in Boston I had the great good fortune to talk about the creation of the biotech industry with Nobel Prize-winning scientist Phil Sharp. I learned quite a bit about the early days of Genentech, Biogen and Alnylam, which all helped birth this unusual drug development ecosystem. And that’s why we can do things like the Endpoints 11. Here’s my talk with Phil Sharp, which you can either watch or read below.

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