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.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).

Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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Len Schleifer (left) and George Yancopoulos, Regeneron (Vimeo)

Eyes on he­mo­phil­ia prize, Re­gen­eron adds a $100M wa­ger on joint de­vel­op­ment cam­paign with In­tel­lia

When George Yancopoulos first signed up Intellia to be its CRISPR/Cas9 partner on gene editing projects 4 years ago, the upstart smartly ramped up its IPO at the same time. Today, Regeneron $REGN is coming back in, adding $100 million in an upfront fee and equity to significantly boot up a whole roster of new development projects.

And they’re highlighting some clinical hemophilia research plans in the process.

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Jean-Jacques Bienaimé, BioMarin chairman and CEO

Bio­Marin holds the line on bleeds with 4-year val­rox up­date on he­mo­phil­ia A — but what's this about an­oth­er de­cline in Fac­tor 8 lev­els?

BioMarin has posted some top-line results for their 4-year followup on the most advanced gene therapy for hemophilia A — extending its streak on keeping a handful of patients free of bleeds and off Factor VIII therapy, but likely stirring fresh worries over a continued drop in Factor VIII levels.

We just don’t know how big a drop.

We’ll see more data when the results are presented at the World Federation of Hemophilia in a couple of weeks. But in a statement out Sunday night, BioMarin $BMRN reported that none of the patients required Factor VIII treatment, adding:

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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