Af­ter gen­er­at­ing AS­CO fer­vor, Io­vance un­veils plans to build $75M cell ther­a­py man­u­fac­tur­ing plant

Af­ter caus­ing a stir weeks ago with its AS­CO ab­stract that hint­ed at the po­ten­tial su­prema­cy of its cell ther­a­py for dif­fi­cult-to-treat ad­vanced cer­vi­cal can­cer, Io­vance on Wednes­day said it would in­vest mil­lions in con­struct­ing a 136,000 square foot fa­cil­i­ty in Philadel­phia.

Io­vance ex­pects to shell out some $75 mil­lion over three years for equip­ment and con­struc­tion, which is ex­pect­ed to kick off in the com­ing weeks. Once com­plet­ed, the fa­cil­i­ty will man­u­fac­ture the com­pa­ny’s tu­mor in­fil­trat­ing lym­pho­cyte (TIL) prod­ucts for sev­er­al thou­sands of pa­tients an­nu­al­ly, and cre­ate sev­er­al hun­dred jobs at full ca­pac­i­ty.

Maria Fardis LinkedIn

“Build­ing our own in­ter­nal pro­duc­tion ca­pa­bil­i­ties will help us re­duce the cost of op­er­a­tions which is nec­es­sary for of­fer­ing broad ac­cess to TIL ther­a­py…Our in­ten­tion is to con­tin­ue col­lab­o­rat­ing with our ex­ist­ing con­tract man­u­fac­tur­ing or­ga­ni­za­tions while we com­plete the fa­cil­i­ty in 2021,” Io­vance chief Maria Fardis said in a state­ment.

Io­vance’s ex­per­i­men­tal TIL ther­a­pies are de­rived from T lym­pho­cytes — im­mune cells that are wired to pen­e­trate tu­mors and snuff out can­cer cells. Nat­u­ral­ly, there aren’t enough T lym­pho­cytes to van­quish can­cer, so Io­vance ex­tri­cates the cells from the body, en­hances their growth in the lab, and re­in­fus­es them back in­to the pa­tient.

The process is sim­i­lar to that of ex­ist­ing per­son­al­ized CAR-T cell ther­a­pies: No­var­tis’ $NVS Kym­ri­ah and Gilead’s $GILD Yescar­ta. Kym­ri­ah sales have suf­fered due to man­u­fac­tur­ing is­sues. In the first quar­ter, the drug — billed as a block­buster — gen­er­at­ed a pal­try $45 mil­lion. How­ev­er, No­var­tis is do­ing its best to shore up man­u­fac­tur­ing, hav­ing bought cell and gene ther­a­py man­u­fac­tur­er Cell­for­Cure.

Fardis, in an in­ter­view with Fierce­Biotech last year, sug­gest­ed Io­vance had re­fined its man­u­fac­tur­ing process down to 22 days and es­tab­lished a tech­nique to freeze the cells to make them eas­i­er to han­dle.

On May 15th, Io­vance’s shares $IO­VA rock­et­ed up af­ter the Cal­i­for­nia-based drug de­vel­op­er post­ed in­trigu­ing da­ta on its TIL reg­i­men, LN-145. Da­ta showed the drug in­duced an ob­jec­tive re­sponse rate (ORR) of 44% and a dis­ease con­trol rate of 89% on the first 27 pa­tients in the planned 59-pa­tient study. In con­trast, Mer­ck’s $MRK check­point in­hibitor Keytru­da was ap­proved for sec­ond-line cer­vi­cal can­cer with a 14% ORR.

The com­pa­ny’s lead ex­per­i­men­tal TIL, li­fileu­cel, is cur­rent­ly be­ing test­ed in a piv­otal melanoma study. Oth­er ther­a­pies in its pipeline are be­ing in­ves­ti­gat­ed for use in head and neck and non-small cell lung can­cer.

Blue­bird Bio $BLUE in March un­veiled its $80 mil­lion fa­cil­i­ty in Durham, North Car­oli­na, which will make its gene-ther­a­py for be­ta tha­lassemia, Zyn­te­glo. Mean­while, No­var­tis is al­so build­ing $55 mil­lion man­u­fac­tur­ing plant in the re­gion to pro­duce its new­ly-ap­proved spinal mus­cu­lar at­ro­phy gene ther­a­py Zol­gens­ma — that costs an eye-pop­ping $2.1 mil­lion — spread across a five-year in­stall­ment plan.

Im­age: Io­vance Bio­ther­a­peu­tics

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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New safe­ty da­ta ex­pose po­ten­tial weak­ness as Pfiz­er's abroc­i­tinib takes on Dupix­ent in eczema

Last September, when Pfizer celebrated positive data from a second Phase III study of abrocitinib, many watchers applauded the efficacy but were still waiting to see whether the JAK1 inhibitor is “safe enough to be a formidable competitor to Dupixent,” the clear leader in the atopic dermatitis field. The full slate of safety data are now out and, according to one analyst, the answer is: probably not.