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

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.


ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology


ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development


CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Therapists Marcela Ot'alora and Bruce Poulter are trained to conduct MDMA-assisted psychotherapy. In this reenactment, they demonstrate how they help guide and watch over a patient who is revisiting traumatic memories while under the influence of MDMA. (Photo: Multidisciplinary Association for Psychedelic Studies)

MD­MA, now in Phase III, shows promise as a PTSD treat­ment

The first time Lori Tipton tried MDMA, she was skeptical it would make a difference.

“I really was, at the beginning, very nervous,” Tipton said.

MDMA is the main ingredient in the club drug known as ecstasy or molly. But Tipton wasn’t taking pills sold on the street to get high. She was trying to treat her post-traumatic stress disorder by participating in a clinical trial.

After taking a dose of pure MDMA, Tipton lay in a quiet room with two specially trained psychotherapists. They sat next to her as she recalled some of her deepest traumas, such as discovering her mother’s body after Tipton’s mother killed two people and then herself in a murder-suicide.

Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

UP­DAT­ED: As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Ted Ashburn. Oncorus

Cowen, Per­cep­tive lead $79.5M Se­ries B for 's­tand­out' biotech shep­herd­ing on­colyt­ic virus to clin­ic

As several Big Pharma players secure biotech partners in the oncolytic virus space for new immuno-oncology combos, Cowen and Perceptive Advisors have come out with their own bet on a startup that promises to shine.

The marquee investors are joining MPM, Deerfield, Celgene, Astellas, Arkin and UBS in backing the drug developer, Oncorus, which will now deploy the $79.5 million in Series B cash toward clinical development of its lead program. Other new investors include Surveyor Capital, Sphera Funds, IMM Investment, QUAD Investment Management, UTC Investment, SV Investment Corp and Shinhan Investment-Private Equity, the last five of which are Korean-based funds.

Fu­til­i­ty analy­sis au­gurs de­feat in piv­otal tri­al test­ing of Nu­Cana's lead drug in metasta­t­ic pan­cre­at­ic can­cer

Nearly two years after making its public debut, UK-based NuCana’s mission to make chemotherapies more potent and safer was dealt a blow, after a pivotal study testing its lead experimental drug halted enrollment in a hard-to-treat advanced form of cancer, following a futility analysis.

The drug, Acelarin, is being evaluated for use in metastatic pancreatic cancer patients who were not considered suitable for combination chemotherapy. In the late-stage ACELARATE study — which compared the experimental drug against the chemotherapy gemcitabine — 200 patients had been enrolled by the sponsor, Clatterbridge Cancer Centre, before an analysis from an independent safety and data monitoring panel suggested the study’s main goal would not be met.

UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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