23andMe finds a buy­er for its IL-36 bis­pe­cif­ic in Almi­rall; Neu­ro­crine, Idor­sia re­vise epilep­sy drug deal

→ The first fruits of 23andMe’s ef­forts to gen­er­ate new drugs off the in­sights it gained from a mas­sive amount of ge­net­ic da­ta are tak­ing shape, and Almi­rall is sign­ing up to ripen one of them. The Span­ish der­ma­tol­ogy drug­mak­er has li­censed a bis­pe­cif­ic an­ti­body that blocks three cy­tokines in the IL-36 cy­tokine fam­i­ly, which are tied to skin con­di­tions such as pso­ri­a­sis and lu­pus, in ad­di­tion to oth­er in­flam­ma­to­ry ail­ments such as ul­cer­a­tive col­i­tis, in­flam­ma­to­ry bow­el dis­ease, and Crohn’s dis­ease.

“As a leader in med­ical der­ma­tol­ogy, we felt Almi­rall was the best com­pa­ny to take this pro­gram for­ward and ul­ti­mate­ly de­vel­op an ef­fec­tive ther­a­py for pa­tients,” Ken­neth Hillan, who suc­ceed­ed Genen­tech vet Richard Scheller as head of ther­a­peu­tics at 23andMe, said in a state­ment.

While it start­ed out as a di­rect-to-con­sumer test­ing ser­vice, 23andMe has moved deep­er in­to the ther­a­peu­tic space in re­cent years, most no­tably through a $300 mil­lion part­ner­ship with Glax­o­SmithK­line.

→ We now know the iden­ti­ty of Idor­sia’s mys­tery part­ner from last year. The Swiss biotech — spun out from J&J’s Acte­lion buy­out — had an­nounced that it pock­et­ed a $5 mil­lion pay­ment from an undis­closed par­ty to score a li­cens­ing op­tion on ACT-709478, a brain pen­e­trat­ing T-type cal­ci­um chan­nel block­er. Now we learn that Neu­ro­crine will pay $45 mil­lion if it ex­er­cis­es the op­tion and up to $365 mil­lion in mile­stones.

“We are ex­cit­ed to lever­age the sci­en­tif­ic ex­per­tise of Idor­sia in T-type cal­ci­um chan­nel in­hi­bi­tion to po­ten­tial­ly ad­vance a Phase 2 ready com­pound to help peo­ple suf­fer­ing from epilep­sy. In ad­di­tion to the treat­ment of epilep­sy, the mod­u­la­tion of the cal­ci­um chan­nel may be use­ful for the treat­ment of oth­er dis­or­ders such as es­sen­tial tremor and pain,” Kevin Gor­man, the CEO at Neu­ro­crine, said in a state­ment.

Phase­Bio has found a deep-pock­et­ed be­liev­er in its blood thin­ner re­ver­sal agent: SFJ Phar­ma­ceu­ti­cals, which has of­fered up to $120 mil­lion to sup­port the clin­i­cal de­vel­op­ment of PB2452. First li­censed from As­traZeneca, the “break­through” drug is de­signed to can­cel the ef­fects of tica­grelor, an an­ti­co­ag­u­lant, in ur­gent or sur­gi­cal sit­u­a­tions. Backed by Black­stone Life Sci­ences and Abing­worth, SFJ will al­so take over the bulk of the clin­i­cal and reg­u­la­to­ry work out­side of the US. In ex­change, Phase­Bio will pay an­nu­al lump sums once (and if) they win ap­provals.

Boehringer In­gel­heim Ven­ture Fund and Dutch in­vestor PPF are lead­ing a $22 mil­lion Se­ries C round for Basel, Switzer­land-based NBE Ther­a­peu­tics to bankroll ear­ly clin­i­cal tri­als of its lead as­set. Rid­ing on re­newed en­thu­si­asm for an­ti­body-drug con­ju­gates, NBE said their plat­form tech is both more pow­er­ful and safer than the ear­li­er gen­er­a­tions of ADC, be­ing im­mune-stim­u­la­to­ry and em­ploy­ing an an­thra­cy­cline pay­load. NBE-002 tar­gets ROR1 in triple-neg­a­tive breast can­cer and lung can­cer, to be fol­lowed by oth­er sol­id can­cer types and lym­phomas.

→ While await­ing an FDA de­ci­sion on its sec­ond shot at an ap­proval, Aca­cia Phar­ma has in-li­censed a short-act­ing, re­versible in­tra­venous seda­tive/anes­thet­ic from Cos­mo Phar­ma. The €10 mil­lion up­front pay­ment will take the form of an eq­ui­ty sale, with an­oth­er €30 mil­lion due up­on US ap­proval of the drug, By­Fa­vo, and more com­mer­cial mile­stones. “Hav­ing a sec­ond prod­uct that shares the same call­ing points and at­trac­tive com­mer­cial mes­sage as Barhem­sys will make the in­vest­ment in our sales and mar­ket­ing teams more ef­fi­cient,” CEO Mike Bolin­der said in a state­ment.

→ Eye-fo­cused gene ther­a­py de­vel­op­er Eye­ven­sys has scored $30 mil­lion in Se­ries B fund­ing with the help of lead in­vestor Boehringer In­gel­heim Ven­ture Fund. Pon­tif­ax, Bpifrance, CapDe­cisif, In­serm Trans­fert, the Glob­al Health Sci­ences Fund and Pure­os Bioven­tures al­so joined to boost their R&D ef­forts, fea­tur­ing a lead Phase II-ready pro­gram for chron­ic non-in­fec­tious uveitis.

→ The cell ther­a­py ex­perts at Jasper Ther­a­peu­tics have brought in an ex­tra $14.1 mil­lion for their Se­ries A, adding Roche Ven­ture Fund to their ros­ter of mar­quee in­vestors. The new cash will help ex­pand the lead clin­i­cal pro­gram, a CD117-tar­get­ed an­ti­body con­ceived as an al­ter­na­tive con­di­tion­ing reg­i­men be­fore stem cell trans­plants.

→ Fol­low­ing the close of its $1 bil­lion-plus sec­ond fund, GHO Cap­i­tal Part­ners has ac­quired Bel­gian CD­MO Ar­de­na, which is fo­cused on ear­ly-stage drug de­vel­op­ment, from Men­tha Cap­i­tal.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Af­ter near­ly a year of de­bate, the Covid-19 vac­cine chal­lenge tri­als are of­fi­cial­ly com­ing

After nearly a year of public advocacy and often rancorous ethical debate, human challenge trials for Covid-19 vaccines are getting off the ground in London.

The UK government’s Covid-19 Vaccine Taskforce and the contract research firm Open Orphan announced today £10 million ($13 million) plan to test experimental Covid-19 vaccines in volunteers whintentionally exposed to the novel coronavirus. The studies, which won’t launch until early 2021, come after 9 months of debate over whether such studies were safe and would actually hasten vaccine development, and they follow a long history of researchers using challenge models to study other respiratory viruses, including flu and the coronaviruses that cause the common cold.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.