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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Fireside chat between Hal Barron and John Carroll, UKBIO19

It’s time we talked about bio­phar­ma — live in Lon­don next week

Zoom can only go so far. And I think at this stage, we’ve all tested the limits of staying in touch — virtually. So I’m particularly happy now that we’ve revved up the travel machine to point myself to London for the first time in several years.

Whatever events we have lined up, we’ve always built in plenty of opportunities for all of us to get together and talk. For London, live, I plan to be right out front, meeting with and chatting with the small crowd of biopharma people we are hosting on October 12 at Silicon Valley Bank’s London headquarters. And there’s a lengthy mixer at the end I’m most looking forward to, with several networking openings between sessions.

Pfizer and BioNTech's original Marvel comic book links evolving Covid vaccine science to Avengers' evolving villain-fighting tools.(Source: Pfizer LinkedIn post)

Pfiz­er, BioN­Tech part­ner with Mar­vel for Avengers and Covid-fight­ing com­ic book

Pfizer and BioNTech are collaborating with Marvel to celebrate “everyday” people getting Covid-19 vaccines in a custom comic book.

In the “Everyday Heroes” digital comic book, an evolving Ultron, one of the Avengers’ leading villains, is defeated by Captain America, Ironman and others. The plotline and history of Ultron is explained by a grandfather who is waiting with his family at a clinic for Covid-19 vaccinations.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024, but the entire inventory will be available until depleted or expired, a company spokesperson said via email.

Eli Lil­ly and Te­va pre­pare for court bat­tle over mi­graine med ri­val­ry

It looks like Eli Lilly and Teva Pharmaceuticals are going to trial.

A federal appeals court on Monday refused to invalidate three of Teva’s patents for its migraine treatment Ajovy, while also declining to issue a summary judgment in favor of either company, which would effectively end the case without a full trial.

Teva filed suit against Lilly back in 2018, alleging that the company infringed upon nine patents with its rival migraine drug Emgality. The rival drugs were both approved in September 2018 for the preventative treatment of migraine, and are designed to block calcitonin gene-related peptide (CGRP), a protein associated with the onset of migraine pain.

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Rep. Vern Buchanan (R-FL) (Bill Clark/CQ Roll Call via AP Images)

Af­ter cov­er­age re­stric­tions for Alzheimer's drugs, bi­par­ti­san House bill would force CMS to re­view drugs in­di­vid­u­al­ly

When Biogen’s controversial Alzheimer’s drug Aduhelm was hit with a national decision from CMS that restricted coverage to only randomized trials, practically guaranteeing a commercial flop in the near term, questions surfaced over why CMS also included all amyloid-targeted monoclonal antibodies for Alzheimer’s disease.

With Eisai and Biogen’s second Alzheimer’s drug, lecanemab, now showing it can slow the rate of cognitive decline versus placebo, lining up for a likely full approval next spring, the question now turns to whether that data, which is being presented at the Clinical Trials on Alzheimer’s Congress in San Francisco in late November, will be enough for CMS when it asks, “Does the anti-amyloid mAb meaningfully improve health outcomes (i.e., slow the decline of cognition and function) for patients in broad community practice?”

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Kaile Zagger, Infinant Health CEO

UC Davis mi­cro­bio­me spin­out re­brands in­fant sup­ple­ment busi­ness with na­ture fo­cus

When Kaile Zagger took the helm of UC Davis spinout Evolve Biosystems several months ago, the company billed itself as a probiotic maker.

However, she believes the company’s Evivo supplement designed to help infants develop a healthy gut microbiome is “so much more” — and that, she said, calls for a rebrand.

Evolve has, well, evolved into Infinant Health, the company announced on Monday. The new name is a mash-up of the words “infant” and “infinite,” representing the company’s goal of expanding beyond infant care. While its sole product, Evivo, is intended for newborns, Infinant is “quickly developing” an option for kids through the age of two.

FDA+ roundup: Ad­comm date set for Cy­to­ki­net­ics heart drug; New gener­ic drug guid­ance to re­duce fa­cil­i­ty de­lays

The FDA on Wednesday set Dec. 13 as the day that its Cardiovascular and Renal Drugs Advisory Committee will review Cytokinetics’ potential heart drug, meaning regulators aren’t likely to meet the Nov. 30 PDUFA date that was previously set.

The drug, known as omecamtiv mecarbil, read out its first Phase III in November 2020, hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as the key to breaking into the market, failing to significantly differ in reducing cardiovascular death from placebo.

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