News brief­ing: Cosen­tyx shows ear­ly pos­i­tive signs in pso­ri­at­ic arthri­tis; Pfiz­er's PhI­Ib for car­dio drug trig­gers $75M mile­stone

No­var­tis’ block­buster Cosen­tyx is seek­ing ap­proval in an­oth­er in­di­ca­tion, and the com­pa­ny re­port­ed pos­i­tive ear­ly Phase II­Ib re­sults Thurs­day.

Look­ing to re­duce joint lin­ing in­flam­ma­tion in pso­ri­at­ic arthri­tis, Cosen­tyx saw ben­e­fits against place­bo af­ter 12 weeks. Though No­var­tis didn’t pro­vide any num­bers in this ear­ly look, the com­pa­ny said the drug showed “sig­nif­i­cant ben­e­fit” on its way to meet­ing the pri­ma­ry end­point.

No­var­tis is as­sess­ing the spe­cif­ic in­flam­ma­tion Cosen­tyx is try­ing to treat, known as syn­ovi­tis, us­ing an ul­tra­sound test. The drug­mak­er ex­pects to re­lease the full 24-week da­ta in 2021.

Cosen­tyx was No­var­tis’ best­seller in the first half of this year, tal­ly­ing near­ly $1.9 bil­lion in glob­al sales. It al­so sold more than any oth­er No­var­tis prod­uct in all of 2019, net­ting the Swiss phar­ma more than $3.5 bil­lion last year, up 25% from 2018.

The drug, an IL-17A in­hibitor, is cur­rent­ly ap­proved across four in­di­ca­tions pso­ri­a­sis, pso­ri­at­ic arthri­tis, anky­los­ing spondyli­tis and non-ra­di­ograph­ic ax­i­al spondy­loarthri­tis. It’s fac­ing po­ten­tial R&D com­pe­ti­tion in the pso­ri­a­sis space from Ab­b­Vie’s Hu­mi­ra suc­ces­sor Skyrizi and UCB’s bimek­izum­ab. — Max Gel­man

Io­n­is bags $75M mile­stone as Pfiz­er kicks off PhI­Ib for car­dio drug

Pfiz­er has treat­ed the first pa­tient of a Phase IIb study of vu­panors­en, the ANGPTL3-tar­get­ing an­ti­sense oligonu­cleotide it li­censed from Io­n­is a year ago.

For Io­n­is, that means re­ceiv­ing a $75 mil­lion mile­stone pay­ment and sit­ting back to let the phar­ma gi­ant han­dle every­thing from here on out.

The goal is to en­roll 260 pa­tients with el­e­vat­ed non-HDL cho­les­terol and triglyc­erides who are re­ceiv­ing a sta­ble dose of a statin. The drug met the pri­ma­ry end­point of sig­nif­i­cant re­duc­tions in triglyc­erides lev­els in Phase IIa, which tar­get­ed those with hy­per­triglyc­eridemia, type 2 di­a­betes and non-al­co­holic fat­ty liv­er dis­ease (NAFLD).

In the new tri­al, in­ves­ti­ga­tors will be eval­u­at­ing mul­ti­ple dos­es and fo­cus on change in non-HDL-C. — Am­ber Tong

Cal­i­for­nia cy­tom­e­try play­er rais­es $120M in Se­ries D

Cytek Bio­sciences has a whole new heap of cash to play with.

The Fre­mont, CA-based biotech has closed a $120 mil­lion Se­ries D round, it an­nounced Thurs­day, that will be used to ex­pand its glob­al in­fra­struc­ture. Cytek fo­cus­es its re­search on flow cy­tom­e­try, a cell analy­sis tech­nique that Cytek hopes can pro­vide bet­ter di­ag­nos­tic tools for can­cer and cell bi­ol­o­gy.

“We are com­mit­ted to ad­vanc­ing the scope, reach and ca­pa­bil­i­ties of flow cy­tom­e­try — and to pro­vid­ing re­searchers and clin­i­cians around the globe with the tools they need to im­prove pa­tient treat­ments,” CEO Wen­bin Jiang said in a state­ment.

Thurs­day’s round was co-led by RA Cap­i­tal and Hill­house Cap­i­tal, with Or­biMed and LYFE Cap­i­tal al­so chip­ping in. RA and Hill­house have al­so joined Cytek’s board of di­rec­tors.

Cytek says its pro­pri­etary plat­form of­fers a more com­plete pic­ture of all the dif­fer­ent cel­lu­lar play­ers in the im­mune sys­tem than pre­vi­ous cy­tom­e­try ef­forts. — Max Gel­man

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Alaa Halawaa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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'Band­ing to­geth­er': 50 fe­male biotech ex­ec­u­tives lay out plans for board di­ver­si­ty, new com­pa­nies and men­tor­ing founders

Earlier this month, during the Silicon Valley Bank meltdown, Angie You recalled the speed with which female biotech CEOs were helping each other connect with bankers, get their wires through and assuage concerns during a financial implosion.

This past weekend, 50 of about 125 women who are part of that Slack group and a broader coalition self-dubbed the Biotech Sisterhood met in person in Cancun for the second rendition of an annual summit connecting female biotech CEOs. The attendance list doubled that of the inaugural gathering in Arizona 12 months ago.

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No­var­tis touts sev­en years of dura­bil­i­ty da­ta for Zol­gens­ma

The same day that Roche touted positive durability and safety data for its spinal muscular atrophy drug Evrysdi, Novartis also made a splash with its multi-million dollar gene therapy for the disease.

Novartis rolled out interim data from two long-term follow-up studies Monday at the 2023 Muscular Dystrophy Association (MDA) Clinical and Scientific Conference. In the first study, LT-001, all children in the trial that were treated after showing symptoms of SMA “maintained all previously achieved motor milestones” up to 7.5 years after being dosed. The average time since Zolgensma was given was 6.86 years.

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Rohan Palekar, 89bio CEO

89bio’s PhII da­ta add to quick suc­ces­sion of NASH read­outs as field seeks turn­around

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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Francesco Marincola, newly-appointed Sonata Therapeutics CSO

Kite's head of re­search leaves for Flag­ship start­up Sonata

Another leader is departing Kite Pharma, and will to spend the “last part” of his career exploring how cancer evades the immune system.

Kite’s senior VP and global head of cell therapy research Francesco Marincola left the Gilead CAR-T unit last week for Sonata Therapeutics. Flagship last May unveiled the startup, which was pieced together from two fledgling biotechs Inzen and Cygnal Therapeutics. As CSO, Marincola will lead Sonata’s push to reprogram cancer cells to make them more immunogenic.

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FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Roche and Lil­ly team up to de­vel­op blood test to de­tect ear­ly signs of Alzheimer's

Eli Lilly is teaming up with Roche to help develop a blood test to detect early signs of Alzheimer’s disease and determine whether a patient should go for further confirmatory testing.

Roche’s Elecsys Amyloid Plasma Panel (EAPP) measures pTau 181 protein assay and APOE E4 assay in human blood plasma – elevations in pTau 181 are present in the early stages of Alzheimer’s, while the presence of APO E4 is the most common genetic risk factor for the disease.

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