J&J un­corks long-term da­ta for Crohn's dis­ease can­di­date; Age-re­lat­ed dis­ease biotech earns Eli Lil­ly's back­ing

J&J and Ab­b­Vie are com­pet­ing for the same Crohn’s dis­ease mar­ket with their re­spec­tive IL-23 drugs, Trem­fya and Skyrizi. On Wednes­day, J&J’s Janssen unit re­vealed da­ta it thinks could prove a key dif­fer­en­tia­tor but ap­pears to lack key con­text.

In long-term, Phase II fol­low-up da­ta stretch­ing to 48 weeks, 65% of pa­tients tak­ing Trem­fya saw their Crohn’s dis­ease en­ter clin­i­cal re­mis­sion, J&J an­nounced. The com­pa­ny did not say what pro­por­tion of pa­tients hit re­mis­sion in the place­bo group, how­ev­er, say­ing re­searchers didn’t mea­sure for com­par­i­son to place­bo af­ter week 12.

While cross-tri­al com­par­isons can be a risky busi­ness, Ab­b­Vie re­port­ed Phase III Crohn’s da­ta in June that showed 52% of ac­tive Skyrizi pa­tients achieve re­mis­sion while 40% on place­bo hit the re­mis­sion mark. Skyrizi was dosed as a main­te­nance ther­a­py, where­as Trem­fya is be­ing stud­ied as a monother­a­py.

Trem­fya pre­vi­ous­ly hit its pri­ma­ry end­point in this Phase II study, re­duc­ing scores in a Crohn’s dis­ease scale from base­line by a sta­tis­ti­cal­ly sig­nif­i­cant amount af­ter 12 weeks. The drug al­so saw a sig­nif­i­cant­ly high­er pro­por­tion of pa­tients achieve re­mis­sion in this time pe­ri­od, with 54%, 56% and 50% in each dos­ing arm, re­spec­tive­ly, hit­ting the mark com­pared to 15.7% on place­bo. — Max Gel­man

Foun­tain Ther­a­peu­tics adds $15M in Se­ries A-2

San Fran­cis­co’s Foun­tain Ther­a­peu­tics earned $11 mil­lion in the first part of its Se­ries A — but thanks to Eli Lil­ly, Alexan­dria Ven­ture In­vest­ments and R42 Group, the biotech has more than dou­bled that raise.

Those three in­vestors join Khosla Ven­tures and Nan Fung Life Sci­ences as back­ers for the age-re­lat­ed dis­ease biotech — and this A-2 brings the com­pa­ny’s to­tal mon­ey raised in the Se­ries A to $26 mil­lion. That mon­ey will be used to ex­pand the com­pa­ny “to the next phase of growth,” ac­cord­ing to a state­ment.

“We look for­ward to build­ing on our pos­i­tive mo­men­tum as we con­tin­ue to build our in­sights, plat­form and pipeline,” said Foun­tain CEO William Greene in a pre­pared state­ment. — Paul Schloess­er

Life sci­ence gi­ant Lab­corp to ac­quire Mass­a­chu­setts CRO Toxikon

Say hel­lo to Lab­corp’s newest as­set.

Lab­corp an­nounced this morn­ing it en­tered an agree­ment with Toxikon to buy out the small, non­clin­i­cal-fo­cused re­search fa­cil­i­ty in Bed­ford, MA, by year’s end. And while no fi­nan­cial de­tails were spec­i­fied, Lab­corp said in a state­ment that it’s a strate­gic move to part­ner with phar­ma­ceu­ti­cal com­pa­nies and biotechs in the Boston area.

Toxikon, which has fo­cused on in vi­vo and in vit­ro test­ing, pro­vides Lab­corp’s sub­sidiary, Lab­corp Drug De­vel­op­ment, with an op­por­tu­ni­ty to ex­pand its tra­di­tion­al tox­i­col­o­gy busi­ness, ac­cord­ing to a Lab­corp state­ment.

“This ac­qui­si­tion ex­tends Lab­corp’s port­fo­lio of full-ser­vice drug de­vel­op­ment and med­ical de­vice so­lu­tions from dis­cov­ery to mar­ket ap­proval,” said Lab­corp Drug De­vel­op­ment’s CEO Paul Kirch­graber. — Paul Schloess­er

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.