J&J pays $500M in cash to grab rights to a new star can­cer drug at ar­genx

J&J ex­ecs be­lieve they have found their next big can­cer drug.

Ear­ly Mon­day the phar­ma gi­ant an­nounced that it was pay­ing Bel­gium’s ar­genx $500 mil­lion — $300 mil­lion as an up­front and $200 mil­lion for eq­ui­ty — to grab the world­wide com­mer­cial rights to cusat­uzum­ab (ARGX-110) to treat acute myeloid leukemia and high-risk myelodys­plas­tic syn­dromes. The deal al­so comes with $1.3 bil­lion in mile­stones.

The deal adds to J&J’s grow­ing im­muno-on­col­o­gy group, adding an an­ti-CD70 check­point strat­e­gy to the mix. Ar­genx’s share price $ARGX spiked 10% on the news in pre-mar­ket trad­ing.

Yus­ri El­sayed

The Bel­gian biotech flagged stel­lar — but very ear­ly-stage — da­ta for this drug in the lead-up to ASH last week. In the Phase I por­tion of the study re­searchers tracked a 92% re­sponse rate and a stun­ning 42% com­plete re­sponse with min­i­mal resid­ual re­sponse among 12 pa­tients.

That’s all very promis­ing, but it al­so cov­ers on­ly 12 pa­tients. J&J will al­so now co-de­vel­op the drug with ar­genx, throw­ing its am­bi­tious on­col­o­gy R&D group in­to the fray.

In the deal — which J&J’s af­fil­i­ate Cilag inked — ar­genx is keep­ing co-pro­mo­tion rights in the US.

This new deal fol­lows a re­cent J&J deal with Chi­na’s Leg­end Biotech on their BC­MA CAR-T, in which J&J pitched in $350 mil­lion in cash. That fol­lowed an­oth­er star turn, which was al­so com­plete­ly un­ex­pect­ed, at AS­CO in 2017. We’re sched­uled to see more da­ta on that drug lat­er to­day.

J&J has done a string of big can­cer drug deals with block­buster up­fronts like this. One of them — apa­lu­tamide (ARN-509) for pre-metasta­t­ic prostate can­cer — is now a star late-stage ther­a­py. J&J picked up this drug with its $1 bil­lion deal for Aragon. These new drugs were part of one leg of the com­pa­ny’s three-leg strat­e­gy for grow­ing rev­enue, with a promise that it can im­prove sig­nif­i­cant­ly on ex­ist­ing drugs — like Ste­lara, In­vokana and Xarel­to — while beef­ing up on a new core fo­cus on pul­monary ar­te­r­i­al hy­per­ten­sion through the Acte­lion buy­out.

“We be­lieve CD70 is an im­por­tant tar­get in the bi­ol­o­gy of se­lect can­cers, and we are ea­ger to ac­cel­er­ate the de­vel­op­ment of this in­no­v­a­tive an­ti­body to­geth­er with ar­genx,” said Yus­ri El­sayed, vice pres­i­dent, hema­to­log­ic ma­lig­nan­cies dis­ease area leader, Janssen Re­search & De­vel­op­ment. “Phase 1/2 da­ta in acute myeloid leukemia showed the ac­tiv­i­ty of cusat­uzum­ab, and we hope to trans­late these find­ings to im­prove out­comes for pa­tients with myeloid ma­lig­nan­cies.”

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.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to clinicaltrials.gov, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.

Sijmen de Vries, Pharming CEO

FDA ap­proves Pharm­ing drug for ul­tra-rare im­mun­od­e­fi­cien­cy dis­ease

US regulators cleared an ultra-rare drug from Pharming Group, by way of Novartis, on Friday afternoon.

The Dutch biotech said the FDA greenlit leniolisib for an immunodeficiency disease known as activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome, or APDS. People 12 years and older can receive the oral drug, to be marketed as Joenja, beginning early next month, Pharming said, five days ahead of the decision deadline set by the FDA as part of a priority review.

Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 163,600+ biopharma pros reading Endpoints daily — and it's free.