CEO Asaf Danziger (Novocure)

Tu­mor-treat­ing elec­tric fields show ear­ly promise in NSCLC — boost­ing both Novo­cure and its Chi­nese biotech part­ner

More than a decade af­ter the FDA first ap­proved elec­tric fields as a treat­ment for glioblas­toma, Novo­cure said it’s seen a promis­ing sig­nal that they could al­so work against non-small cell lung can­cer.

Af­ter re­view­ing da­ta at an in­ter­im analy­sis, Novo­cure said, the in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee sug­gest­ed down­siz­ing and short­en­ing the Phase III tri­al — from 18-month fol­lowup on 534 pa­tients to 12-month fol­lowup on 276 pa­tients. Fol­low­ing the orig­i­nal tri­al pro­to­col is “like­ly un­nec­es­sary and pos­si­bly un­eth­i­cal,” the DMC told the com­pa­ny; giv­en what they have seen, a small­er tri­al with short­er fol­lowup should pro­vide suf­fi­cient sta­tis­ti­cal pow­er for both the pri­ma­ry end­point in over­all sur­vival and sec­ondary end­points.

Da­ta from 210 pa­tients were in­clud­ed for the analy­sis.

“Pend­ing reg­u­la­to­ry ap­proval, the rec­om­mend­ed pro­to­col ad­just­ments could ac­cel­er­ate tri­al com­ple­tion by more than a year,” CEO Asaf Danziger said in a state­ment. The LU­NAR tri­al is orig­i­nal­ly sched­uled to wrap in 2023.

In­vestors were pleased, bid­ding shares $NVCR up 53.55% to $202.5.

Saman­tha Du

The ear­ly signs of ef­fi­ca­cy could al­so bode well for Zai Lab, which has li­censed Chi­na rights to all ap­pli­ca­tions of the de­vice, ac­cord­ing to Jef­feries an­a­lyst Michael Yee. Lung can­cer preva­lence in Chi­na is 3 times as high as that in the US, and the pos­i­tive da­ta — when they ar­rive — could give Saman­tha Du’s team added lever­age in re­im­burse­ment ne­go­ti­a­tions, he not­ed. Zai Lab’s stock on Nas­daq $ZLAB shot up 13.83% to $150.31.

Al­ready cleared for brain can­cer (un­der the brand name Op­tune) and a rare type of can­cer in the lung and chest called ma­lig­nant pleur­al mesothe­lioma, the treat­ment is in oth­er tri­als for brain metas­tases, gas­tric can­cer, liv­er can­cer, pan­cre­at­ic can­cer and ovar­i­an can­cer.

With a fre­quen­cy range be­tween 100 to 500 kHz, tu­mor treat­ing fields (or TT fields) are de­signed to specif­i­cal­ly pen­e­trate the can­cer cell mem­brane and stop their di­vi­sion.

Novo­cure has pre­vi­ous­ly shown that re­cur­rent GBM pa­tients who un­der­went TT fields treat­ment saw im­prove­ment in sur­vival com­pa­ra­ble to that of a sec­ond round of chemother­a­py — mi­nus the side ef­fects like pain, nau­sea, fa­tigue or di­ar­rhea.

In the NSCLC lung can­cer tri­al, which is dubbed LU­NAR and fo­cus­es on stage 4 pa­tients, in­ves­ti­ga­tors want­ed to tease out the ef­fect of TT fields when added to check­point in­hibitors or the chemo agent do­c­etax­el.

“Com­bi­na­tion ther­a­py is a cor­ner­stone of can­cer care,” ex­ec­u­tive chair­man William Doyle said, “and we be­lieve us­ing TTFields to­geth­er with oth­er can­cer treat­ments, in­clud­ing im­munother­a­pies, may lead to bet­ter out­comes for some pa­tients.”

Where­as GBM pa­tients would wear an elec­tric patch on their heads, the NSCLC ap­pli­ca­tion in­volves wear­ing “four elec­tri­cal­ly in­su­lat­ed elec­trode ar­rays on the chest” while car­ry­ing on their reg­u­lar dai­ly lives.

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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Mene Pangalos (AstraZeneca via YouTube)

As­traZeneca shuts the PhI­II door for Ion­is' PC­SK9 drug de­spite pos­i­tive PhI­Ib

When Ionis and AstraZeneca unveiled the first round of mid-stage data for their antisense PCSK9 drug, Mene Pangalos, AstraZeneca’s EVP of biopharmaceuticals R&D, underscored the drug’s “potential best-in-class efficacy profile.”

But now that the second batch is in, it appears AZD8233 isn’t hitting the mark after all.

Ionis announced Friday morning that although the candidate, also dubbed ION449, met the primary endpoint in the Phase IIb SOLANO trial, its partners at AstraZeneca have decided not to move it into Phase III studies because the “results did not achieve pre-specified efficacy criteria.”

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Up­dat­ed: Bio­gen throws it­self back in­to mud­dled da­ta ar­gu­ments with more de­tails on its an­ti­sense ALS drug

With a highly watched FDA decision deadline coming in late January, Biogen and Ionis dropped the full data on the Phase III study of their ALS drug tofersen in the New England Journal of Medicine on Wednesday.

Biogen is looking for approval for tofersen in a very small subset of ALS patients — some 2%, according to the paper — who have a SOD1 gene mutation, which has previously been linked to ALS. Tofersen is meant to reduce levels of mutant SOD1 proteins.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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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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