J&J wows with a $350M cash deal to part­ner on CAR-T with Leg­end, a one-time un­known un­til its star turn at AS­CO

J&J has found its next big can­cer drug. In Chi­na.

The phar­ma gi­ant has agreed to pay $350 mil­lion up­front to part­ner with Leg­end Biotech to de­vel­op its BC­MA-tar­get­ing CAR-T LCAR-B38M for mul­ti­ple myelo­ma.

Don’t know Leg­end? You should.

The vir­tu­al­ly un­known biotech wowed AS­CO with ear­ly-stage da­ta on its CAR-T and clear­ly caught J&J’s at­ten­tion. The deal vaults J&J in­to an in­tense­ly com­pet­i­tive race to get the first BC­MA cell ther­a­py to an ap­proval, with blue­bird bio in the lead and Juno and oth­ers in hot pur­suit.

Re­searchers for the com­pa­ny re­port­ed that among 35 re­lapsed, drug-re­sis­tant pa­tients, 33 — 94% — demon­strat­ed clin­i­cal re­mis­sion rang­ing from a com­plete to a par­tial re­sponse. There was a 100% ob­jec­tive re­sponse rate, ac­cord­ing to in­ves­ti­ga­tors.

The in­ves­ti­ga­tors al­so flagged some promis­ing signs of dura­bil­i­ty.

That drug is now un­der re­view by Chi­nese reg­u­la­tors, with a clin­i­cal plan be­ing fleshed out for the US.

In ad­di­tion to pay­ing half the de­vel­op­ment costs, J&J al­so agreed to pay Leg­end half the prof­its from glob­al sales, with the Chi­nese biotech tak­ing 70% of the haul in Chi­na.

J&J has done a string of big can­cer drug deals with big 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.

And it has one more to add to that list.

“De­spite sig­nif­i­cant ad­vances, mul­ti­ple myelo­ma re­mains an in­cur­able dis­ease for most pa­tients, cre­at­ing the need for ad­di­tion­al, high­ly ac­tive op­tions. LCAR-B38M pro­vides an in­no­v­a­tive ap­proach with the po­ten­tial to trans­form the treat­ment of myelo­ma,” said Janssen’s glob­al head of on­col­o­gy Pe­ter Lebowitz. “We look for­ward to col­lab­o­rat­ing with the pi­o­neer­ing sci­en­tif­ic team at Leg­end and ap­ply­ing our ex­per­tise to the de­vel­op­ment of this cell ther­a­py, with the goal of build­ing reg­i­mens aim­ing for a cure.”


Pic­tured: Nan­jing, Chi­na on April 27th, 2017  shut­ter­stock

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Image: Shutterstock

Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Mer­ck scraps their $425M Covid-19 drug in lat­est pan­dem­ic set­back

Seven months after paying $425 million cash to acquire it, Merck is scrapping a Covid-19 drug they hoped could provide one of the only treatments for severe hospitalized patients.

Merck’s decision comes after they faced significant and unexpected regulatory delays in getting the drug, known as MK-7110 or CD24Fc, across the finish line. The Big Pharma licensed the drug under the belief that it had already shown sufficient benefit in severe patients and they could help scale it up far faster than OncoImmune, its former owner, could. But in February, the company reported that the FDA insisted Merck run a new trial before seeking authorization.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Look­ing to ce­ment its lead in packed MS mar­ket, Roche's Ocre­vus un­corks new da­ta in ear­ly-stage pa­tients

Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.

After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.

J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.

Osman Kibar (Samumed, now Biosplice)

Os­man Kibar lays down his hand at Sa­mumed, step­ping away from CEO role as his once-her­ald­ed an­ti-ag­ing biotech re­brands

Samumed made quite the entrance back in 2016, when it launched with some anti-aging programs and a whopping $12 billion valuation. That level of fanfare was nowhere to be found on Thursday, when the company added another $120 million to its coffers and quietly changed its name to Biosplice Therapeutics.

Why the sudden rebrand?

“We did that for obvious reasons,” CFO and CBO Erich Horsley told Endpoints News. “The name Biosplice echoes our science much more than Samumed does.”

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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