Altasciences CEO Chris Perkin, via YouTube

Cana­di­an CRO Al­ta­sciences kicks off client man­u­fac­tur­ing ex­pan­sion in Philadel­phia

As Philadel­phia con­tin­ues to gar­ner the in­ter­est of com­pa­nies like WuXi AppTec and SK, a Que­bec-based CRO is al­so look­ing to ex­pand man­u­fac­tur­ing op­er­a­tions in the City of Broth­er­ly Love on be­half of a client.

Al­ta­sciences, a drug for­mu­la­tion and man­u­fac­tur­ing CRO, is con­struct­ing a man­u­fac­tur­ing fa­cil­i­ty for Cal­i­for­nia-based Al­ladapt Im­munother­a­peu­tics in the greater Philadel­phia area. Al­ladapt is cur­rent­ly de­vel­op­ing a pre­ci­sion ther­a­peu­tic to ad­dress IgE-me­di­at­ed food al­ler­gies.

As re­port­ed last year, Al­ta­sciences has been con­tract­ed to con­struct the 53,000-square-foot build­ing.  The project, whose cost was not dis­closed to End­points News, is sched­uled to be com­plet­ed some­time in 2023, but no ex­act date was con­firmed.

How­ev­er, Al­ladapt did se­cure a $119 mil­lion fi­nanc­ing round in June, which will go to­ward a build­out of a man­u­fac­tur­ing fa­cil­i­ty as well as the de­vel­op­ment of a lead prod­uct can­di­date, and tri­al prepa­ra­tion.

Al­ta­sciences will man­age all as­pects of the project, in­clud­ing ware­hous­ing, re­lease man­age­ment, man­u­fac­tur­ing, qual­i­ty as­sur­ance and fin­ished prod­uct re­lease. Ac­cord­ing to Al­ta­sciences, their client has de­vel­oped the for­mu­la­tion and man­u­fac­tur­ing process­es for the fa­cil­i­ty.

Ben Reed

“We are pleased to con­tin­ue sup­port­ing Al­ladapt in their im­por­tant goal of de­vel­op­ing a sin­gle ther­a­peu­tic to ad­dress a wide range of mono- and mul­ti-food al­ler­gies, and we look for­ward to ful­fill­ing their Phase III and com­mer­cial re­quire­ments,” said Ben Reed, the gen­er­al man­ag­er of CD­MO Ser­vices at Al­ta­sciences, in a state­ment.

Ac­cord­ing to Al­ladapt, their lead can­di­date, dubbed ADP101, is be­ing de­vel­oped for the mit­i­ga­tion of food al­ler­gies that can be pro­voked by ei­ther sin­gle or mul­ti­ple pro­teins from a va­ri­ety of dif­fer­ent foods. The drug is based on an in­tel­lec­tu­al prop­er­ty es­tate that in­cludes patents and ac­com­pa­ny­ing clin­i­cal da­ta li­censed from Stan­ford Uni­ver­si­ty.

For its part, Al­ta­sciences has been steadi­ly grow­ing in the US, as the com­pa­ny last year ac­quired spaces in Los An­ge­les and ac­quired Calvert Lab­o­ra­to­ries, a pre­clin­i­cal CRO in Penn­syl­va­nia, build­ing out its pres­ence on the coasts.

The com­pa­ny in Jan­u­ary ac­quired Sin­clair Re­search, a pre­clin­i­cal CRO in Mis­souri, gain­ing 80 an­i­mal rooms, and full-ser­vice IND and NDA-en­abling tox­i­col­o­gy and safe­ty phar­ma­col­o­gy ser­vices.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 150,800+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.