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

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.


Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

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Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

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News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Search­ing for the next block­buster to fol­low Darza­lex, J&J finds a $150M an­ti-CD38 drug from part­ner Gen­mab

Now that J&J and Genmab have thrust Darzalex onto the regulatory orbit for first-line use in multiple myeloma, the partners are lining up a deal for a next-gen follow-on to the leading CD38 drug.

Janssen — J&J’s biotech unit — has its eyes on HexaBody-CD38, a preclinical compound generated on Genmab’s tech platform designed to make drugs more potent via hexamerization.

Genmab is footing the bill on studies in multiple myeloma and diffuse large B-cell lymphoma; once it completes clinical proof of concept, Janssen has the option to license the drug for a $150 million exercise fee. There’s also $125 million worth of milestones in play.

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Savara shares are crushed as PhI­II tri­al flunks pri­ma­ry, key sec­on­daries — but they can’t stop be­liev­ing

In­vestors are in no mood to hear biotechs tout the suc­cess of a “key” sec­ondary end­point when the piv­otal Phase III flunks the pri­ma­ry goal. Just ask Savara. 

The Texas biotech $SVRA went look­ing for a sil­ver lin­ing as com­pa­ny ex­ecs blunt­ly con­ced­ed that Mol­gradex, an in­haled for­mu­la­tion of re­com­bi­nant hu­man gran­u­lo­cyte-macrophage colony-stim­u­lat­ing fac­tor (GM-CSF), failed to spur sig­nif­i­cant­ly im­proved treat­ment out­comes for pa­tients with a rare res­pi­ra­to­ry dis­ease called au­toim­mune pul­monary alve­o­lar pro­teinosis, or aPAP.

As an­oth­er an­tibi­otics biotech sinks in­to a cri­sis, warn­ings of a sec­tor ‘col­lapse’

Another antibiotics company is scrambling to survive today, forcing the company’s founding CEO to exit in a reorganization that eliminates its research capabilities as the survivors look to improve on minuscule sales of their newly approved treatment. And the news — on top of an alarming series of failures — spurred at least one figure in the field to warn of a looming collapse of the antimicrobial resistance research field.

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'We kept at it': Jef­frey Blue­stone plots late-stage come­back af­ter teplizum­ab shown to de­lay type 1 di­a­betes

Late-stage da­ta pre­sent­ed at the Amer­i­can Di­a­betes As­so­ci­a­tion an­nu­al meet­ing in 2010 pushed Eli Lil­ly to put a crimp on teplizum­ab as the phar­ma gi­ant found it un­able to re­set the clock on new­ly di­ag­nosed type 1 di­a­betes. At the same con­fer­ence but in dif­fer­ent hands nine years lat­er, the drug is mak­ing a crit­i­cal come­back by scor­ing suc­cess in an­oth­er niche: de­lay­ing the on­set of the dis­ease.

In a Phase II tri­al with 76 high-risk in­di­vid­u­als — rel­a­tives of pa­tients with type 1 di­a­betes who have di­a­betes-re­lat­ed au­toan­ti­bod­ies in their bod­ies — teplizum­ab al­most dou­bled the me­di­an time of di­ag­no­sis com­pared to place­bo (48.4 months ver­sus 24.4 months). The haz­ard ra­tio for di­ag­no­sis was 0.41 (p=0.006).

Fol­low­ing CAR-T pi­o­neer­s' foot­steps, Tes­sa launch­es Chi­na JV in $120M deal

These days just about every biotech se­ri­ous about glob­al de­vel­op­ment — and not just com­mer­cial­iza­tion — has a Chi­na strat­e­gy. Tes­sa Ther­a­peu­tics, a Bay­lor as­so­ci­at­ed out­fit based out of Sin­ga­pore, is no ex­cep­tion.

Tak­ing a page out of the CAR-T pi­o­neers’ play­book, Tes­sa is es­tab­lish­ing a joint ven­ture with Chi­na-Sin­ga­pore Guangzhou Knowl­edge City, which is ini­tial­ly putting down $40 mil­lion for a 13% stake with $40 mil­lion more to come in a sec­ond stage. The biotech, which now re­tains an 87% con­trol, is al­so rolling out its own con­tri­bu­tions in two phas­es, start­ing with $20 mil­lion and all its tech­nol­o­gy li­cense rights for Chi­na.