News brief­ing: Re­gen­eron/Sanofi post pos­i­tive PhI­II Dupix­ent da­ta in pe­di­atric asth­ma; Vineti scores $33M Se­ries C ex­ten­sion

Re­gen­eron and Sanofi re­vealed pos­i­tive Phase III da­ta for their block­buster Dupix­ent on Tues­day, paving a po­ten­tial path for­ward in pe­di­atric asth­ma.

Dupix­ent, eval­u­at­ed in chil­dren be­tween ages 6 and 11, met its pri­ma­ry end­point of low­er­ing the rate of se­vere asth­ma at­tacks in two pa­tient pop­u­la­tions by 65% and 59% per year com­pared to place­bo. The drug al­so showed im­proved lung func­tion by 10.15 and 10.53 per­cent­age points over base­line, com­pared to 4.83 and 5.32 per­cent­age points for place­bo.

The tri­al en­rolled 408 chil­dren with mod­er­ate-to-se­vere asth­ma who did not see im­prove­ments up­on the stan­dard of care, in this case in­haled cor­ti­cos­teroids. Dur­ing the 52-week treat­ment pe­ri­od, pa­tients re­ceived in­jec­tions of Dupix­ent or place­bo every two weeks, ei­ther at the 100 mg or 200 mg dosage lev­el.

Dupix­ent is al­ready ap­proved to treat asth­ma in pa­tients old­er than 12 as well as a few oth­er in­di­ca­tions — atopic der­mati­tis and chron­ic rhi­nos­i­nusi­tis with nasal polyps.

With Tues­day’s re­sults, Re­gen­eron and Sanofi plan to file for an ap­proval in the pe­di­atric asth­ma field some­time in the first quar­ter of 2021. Dupix­ent is the duo’s biggest sell­er, net­ting more than $1.9 bil­lion in glob­al sales through the first half of 2020. — Max Gel­man

Vineti adds $33M to Se­ries C and Eli Cas­din to its board

Vineti has some new cash — and a new high-pro­file board mem­ber.

Amy DuRoss

The San Fran­cis­co-based com­pa­ny an­nounced a $33 mil­lion ex­ten­sion from its Feb­ru­ary Se­ries C round and that Eli Cas­din, founder of Cas­din Cap­i­tal, has joined its board of di­rec­tors. Vineti plans to use the funds to help boost de­vel­op­ment for its per­son­al­ized late-stage can­cer treat­ments, in­clud­ing CAR-T ther­a­py.

Tues­day’s ex­ten­sion was led by Car­di­nal Health with par­tic­i­pa­tion from Marc Be­nioff and ex­ist­ing Vineti in­vestors, in­clud­ing Canaan, Thresh­old Ven­tures, Sec­tion 32, Cas­din Cap­i­tal, No­var­tis Phar­ma AG, McKesson Ven­tures, and Life­Force Cap­i­tal. Over­all, Vineti has raised more than $115 mil­lion to­tal.

“2020 has dri­ven one key point home — the con­tin­ued suc­cess of ad­vanced ther­a­pies re­lies on stan­dard­ized, de­pend­able in­fra­struc­ture,” Vineti CEO Amy DuRoss said in a state­ment. “Vineti was built for [the] pur­pose to serve per­son­al­ized med­i­cine.” — Max Gel­man

Abi­vax grabs a €15M life­line lead­ing to ul­cer­a­tive col­i­tis da­ta

French biotech Abi­vax has ob­tained a $17.6 mil­lion (€15 mil­lion) loan from Kre­os Cap­i­tal to keep it afloat un­til a key read­out in the sec­ond quar­ter of 2021.

Hart­mut Ehrlich

“We con­tin­ue to fo­cus on the ABX464 Phase 2b ul­cer­a­tive col­i­tis tri­al, with top-line re­sults ex­pect­ed in Q2 2021, while the ABX464 Phase 2a study in rheuma­toid arthri­tis is al­so pro­gress­ing well,” CEO Hart­mut Ehrlich said in a state­ment. “Fur­ther­more, the fi­nanc­ing will be used to ad­vance the projects that are cru­cial for the fu­ture de­vel­op­ment of the Com­pa­ny, such as the prepa­ra­tion of the clin­i­cal Phase 3 in UC and the ini­ti­a­tion of a piv­otal Phase 2b/3 study in Crohn’s dis­ease.”

A small mol­e­cule de­signed to mod­u­late RNA splic­ing, ABX464 is al­so be­ing test­ed in a Phase IIb/Phase III tri­al for Covid-19.

Kre­os’ debt fund­ing is di­vid­ed in­to two tranch­es. The first €10 mil­lion is to be ful­ly drawn im­me­di­ate­ly, while the oth­er €5 mil­lion will be col­lect­ed be­fore No­vem­ber 1. Abi­vax, which is cur­rent­ly fo­cused on chron­ic in­flam­ma­to­ry dis­eases, said it will be look­ing for oth­er fi­nanc­ing op­tions. — Am­ber Tong

Twist and Neo­gene to work to­geth­er on CAR-T and TCR can­di­dates 

Twist Bio­science and Neo­gene Ther­a­peu­tics are join­ing forces to work on CAR-T and TCR ther­a­pies for can­cer pa­tients.

Emi­ly Lep­roust

Un­der the strate­gic part­ner­ship, Twist will cre­ate a TCR li­brary a self-pro­claimed “li­brary of li­braries” to aid Neo­gene’s search for en­gi­neered TCRs against tar­gets in can­cer. Twist will al­so use the li­brary to dis­cov­er an­ti­bod­ies for fu­ture Neo­gene CAR-T can­di­dates.

The com­pa­nies kept the fi­nan­cial terms of the deal un­der wraps, but said that Twist will get tech­nol­o­gy ac­cess fees, and mile­stones and roy­al­ties for any an­ti­bod­ies or TCRs that come from the part­ner­ship. Neo­gene gets ex­clu­sive rights to the syn­thet­ic TCR li­brary for tar­get­ing vi­ral and neo-anti­gens in on­col­o­gy.

“Putting our plat­forms to­geth­er, we be­lieve we will be able to ex­pe­dite the iden­ti­fi­ca­tion and ge­net­ic en­gi­neer­ing of TCR genes to cre­ate per­son­al­ized T cell ther­a­pies for can­cer, bring­ing new hope to ad­dress the cur­rent lim­i­ta­tions of treat­ments avail­able to­day,” Twist CEO and co-founder Emi­ly Lep­roust said in a state­ment. — Nicole De­Feud­is 

Australia’s Avance Clinical: no IND required and a 43.5% rebate on clinical spend for CGT biotechs

No IND Re­quired for Cell and Gene Ther­a­py Stud­ies with Aus­tralia’s Ac­cred­it­ed CRO Avance Clin­i­cal

Avance Clinical is the specialist Australian CRO, with CGT accreditation, for international biotechs that leverages Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend.

Learn more about Avance ClinicReady here.
Contact us about your next study.
Download our Frost & Sullivan APAC CRO Report here. 

The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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