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

For years, paper-based processes and individual point solutions dominated the clinical research landscape, and patient participation in clinical trials was largely an in-person engagement. But when the COVID-19 pandemic took a stronghold, traditional clinical trial methods emerged as inadequate, putting clinical trials and the life sciences industry at a crossroads. Practically overnight, the industry had to rapidly shift to decentralized clinical trial methods, while maintaining data quality and regulatory compliance.

Douglas Fambrough, Dicerna CEO (Dicerna via YouTube)

Early this year researchers at Novo Nordisk were beaming as they announced the first drug identified in their RNAi alliance with Dicerna was headed into the clinic. And now they’re coming back for the whole thing.

This morning the Copenhagen-based pharma giant put out word that it is buying Dicerna $DRNA — an RNAi pioneer that has had its up and downs over the years — for $3.3 billion. Novo is paying $38.25 a share — an 80% premium.

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Gilead is going all in — hook, line and sinker — on its oncology alliance with Arcus. And they are going for broke.

The big biotech unveiled a deal that now delivers $725 million in opt-in payments covering the clinical development programs for Arcus, ranging from their closely watched anti-TIGIT programs for domvanalimab and AB308 to etrumadenant (the A2a/A2b adenosine receptor antagonist) and quemliclustat, the small molecule CD73 inhibitor. Gilead will also cover half of the development costs, handing Terry Rosen’s biotech a deal that gives them a clear cash runway to achieving all its goals in oncology.

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A new cell and gene therapy testing facility in Philadelphia’s Navy Yard is officially opened, WuXi ATU announced Monday.

The new facility includes 140,000 square feet worth of laboratories, and will enhance the company’s contract testing, development and manufacturing organization business model by tripling the company’s previous capacity.

The move helps strengthen the existing testing capacity and capability, and combines the company’s powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA technology for AAV manufacturing and XLenti stable solutions for lentiviral manufacturing, it says in a press release.

Thermo Fisher CEO Mark Casper

Another week, another win for the North Carolina biotech community.

This time, it’s Thermo Fisher Scientific, the Massachusetts-based contract giant, that recently announced it had plans to build a manufacturing plant. The winner is? Mebane, NC, a 15,000-person town 25 miles northwest of Durham.

The 375,000-square-foot plant at the Buckhorn Industrial Park will manufacture pipette tips for laboratory research and bioscience use. It’s a result from a $192.5 million contract with the Department of Defense that was announced back in September, in which the company pledged to increase its ability to support Covid-19 testing.

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The holding company of a South Korean vaccine maker is in the final talks to make an investment into a US gene therapy firm.

SK Biosciences is in the process of signing a deal with the Center for Breakthrough Medicines (CBM), a Philadelphia-based CDMO. If finalized, the deal will come eight months after SK’s takeover of the French gene and cell therapy company Yposkesi.

With this move, SK takes itself a step closer to establishing a value chain of synthetic and bio pharmaceuticals in the US, Europe and Asia by 2025, the company’s head of the investment center Lee Dong-hoon said in a presentation. The CBM is known for its production of plasmid DNA. With SK’s investment, it will expand manufacturing facility in the Cellicon Valley cell and gene therapy cluster by 699,654 square feet.

Catherine Stehman-Breen and Vic Myer, Chroma CEO and CSO

A handful of the world’s most prominent gene editing-focused academics have been working for over a year on a new company built around a new approach for modifying DNA to treat disease. Known as Chroma Medicine, it launched on Wednesday with $125 million in early funding from Atlas, Newpath, Cormorant and several other VCs.

Chroma will focus on a markedly different way of modifying the genome than most of the gene editing biotechs that have arisen since CRISPR was pioneered nearly a decade ago. Instead of trying to erase or rewrite portions of a patient’s actual DNA — those As, Ts, Cs and Gs — Chroma will try to change the way that DNA is expressed in the cell.

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Sree Kant, BAKX Therapeutics CEO

BAKX Therapeutics emerged from stealth in a big way back in July, striking an $852 million deal with Ipsen for its lead cancer candidate, a small molecule designed to activate the body’s natural process for programmed cell death. And Ipsen’s putting a bit more cash in the company’s coffers to see that program into the clinic.

CEO Sree Kant unveiled a $25 million Series A round on Thursday, led by AB Magnitude Ventures Group with a hand from Ipsen and Sherpa Healthcare Partners. The funds will be used to advance the company’s BAKX activator program, which traces back to pioneering work around apoptosis by the Dana-Farber Cancer Institute’s Loren Walensky and Albert Einstein College of Medicine’s Evripidis Gavathiotis.

President Joe Biden listens as Pfizer CEO Albert Bourla speaks (Patrick Semansky/AP Images)

Pfizer’s pill to treat Covid-19 is outpacing its top rival from Merck not only in terms of efficacy data but now in the size of its US government contract, too.

The US on Thursday announced it will pay $5.29 billion for 10 million courses of Pfizer’s potential treatment, which is the largest single procurement of any therapeutic or vaccine since the pandemic began. And at $529 per course for the Pfizer pill, that’s significantly cheaper than the $2.2 billion the US paid for just 3 million courses of Merck’s treatment, which adds up to about $730 per course.
https://endpts.com/j-age-related-disease-biotech-earns-eli-lillys-backing/