UCB, Bio­gen ad­mit de­feat in PhII lu­pus tri­al, adding to a string of late-stage fail­ures in the field

A late-stage lu­pus pro­gram at UCB and Bio­gen has fol­lowed sev­er­al ri­vals in­to a wall.

With­out pro­vid­ing de­tails, the part­ners re­port­ed that their drug, dapirolizum­ab pe­gol (DZP), had failed to meet the pri­ma­ry end­point, as mea­sured by dose re­sponse at 24 weeks on a scale called the British Isles Lu­pus As­sess­ment Group-based Com­pos­ite Lu­pus As­sess­ment (BI­CLA). The phase IIb tri­al in­volved 182 pa­tients suf­fer­ing from mod­er­ate­ly-to-se­vere­ly ac­tive sys­temic lu­pus ery­the­mato­sus, de­spite stan­dard-of-care treat­ment. Pa­tients in the study were ei­ther giv­en the drug or a place­bo, and al­though in­ves­ti­ga­tors cit­ed con­sis­tent im­prove­ments in pa­tients on the drug, the ex­per­i­men­tal treat­ment did not achieve a sta­tis­ti­cal­ly sig­nif­i­cant (p-val­ue of 0.06) ef­fect.

Pe­ter Welford

There’s no rea­son to pan­ic, though, ac­cord­ing to Jef­feries’ Pe­ter Welford, who la­beled the re­sults “not al­to­geth­er un­sur­pris­ing giv­en this no­to­ri­ous­ly dif­fi­cult to treat in­di­ca­tion.”

(W)e un­der­stand that con­sis­tent, and po­ten­tial­ly mean­ing­ful im­prove­ments were demon­strat­ed across the ma­jor­i­ty of clin­i­cal end­points com­pared to place­bo, and bio­mark­er da­ta were sup­port­ive. Along with part­ner Bio­gen, UCB is con­sid­er­ing next steps for the pro­gramme. DZP was safe and well tol­er­at­ed. SLE tri­als have a no­to­ri­ous­ly high at­tri­tion rate, hence we had not as­cribed any val­ue to DZP in our val­u­a­tion.

The sen­ti­ment was echoed by in­vestors, with UCB (Eu­ronext Brus­sels: $UCB) and Bio­gen $BI­IB shares down a mere 1.2% and 1.5% re­spec­tive­ly.

Late-stage lu­pus fail­ures have be­come a bit of a norm, with Xen­cor $XN­CR, As­traZeneca $AZN and Sanofi’s $SNY Abl­ynx all con­ced­ing in re­cent months that their drugs failed to make the cut in treat­ing the au­toim­mune dis­ease.

UCB and Bio­gen be­gun their study in 2016 hop­ing that their an­ti-CD40L drug — once ex­plored as a treat­ment for amy­otroph­ic lat­er­al scle­ro­sis — would be dif­fer­ent. They will now have a hard­er time ex­plain­ing how.

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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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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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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Mer­ck touts new da­ta for Keytru­da com­bos in NSCLC at North Amer­i­can con­fer­ence

Merck marched out new data from two studies on Friday to back king Keytruda — the drug that made the Big Pharma $11.1 billion last year — in advanced non-small cell lung cancer (NSCLC).

At the IASLC 2020 North America Conference on Lung Cancer, Merck read out long-term data from Cohort G of its Keynote-021 study, which assessed Keytruda in combination with chemotherapy. It also touted results from a Phase I/II study testing Keytruda and quavonlimab, its anti-CTLA-4 therapy, as a first-line therapy.

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.

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.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.