Nan­jing Leg­end wows AS­CO re­searchers with ear­ly da­ta on a BC­MA-tar­get­ed CAR-T con­tender

Chi­na’s Nan­jing Leg­end Biotech is a vir­tu­al un­known in the CAR-T field. But it gained mar­quee sta­tus at AS­CO to­day with stel­lar ear­ly mul­ti­ple myelo­ma da­ta on a drug tar­get­ed at B-cell mat­u­ra­tion pro­tein, or BC­MA.

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.

Of the first 19 pa­tients to reach the four-month mark spec­i­fied in the tri­al, a re­mark­able 14 achieved a “strin­gent” com­plete re­sponse (sCR), which is as­so­ci­at­ed with longer sur­vival times. And 5 pa­tients who hit the one-year mark were still in the sCR stage.

Xi­ao­hu (Frank) Fan

Look­ing past the CD19 bio­mark­er, BC­MA of­fers one of the most promis­ing tar­gets in CAR-T. And this is, to date, the largest pa­tient group yet re­port­ed on. There are, how­ev­er, some sig­nif­i­cant caveats to point out. Its BC­MA ri­val blue­bird bio points out that these pa­tients ev­i­dent­ly weren’t as sick as the ones they treat­ed, with few­er ear­li­er drug fail­ures.

But you can be sure that there will be plen­ty of an­a­lysts pour­ing over the da­ta to­day to start cal­cu­lat­ing how the lead­ers all line up.

The same safe­ty is­sues that have plagued in­ves­ti­ga­tors for years now were ev­i­dent in the study. 85% of the pa­tients in the study ex­pe­ri­enced cy­tokine re­lease syn­drome, with two ex­pe­ri­enc­ing a grade 3 case that re­quired Actem­ra to tamp down on the in­flam­ma­to­ry re­sponse. All those pa­tients re­cov­ered.

And no mat­ter who is do­ing the work, CAR-T ap­pears to be more promis­ing than ever for this group of pa­tients.

“While it’s still ear­ly, these da­ta are a strong sign that CAR T-cell ther­a­py can send mul­ti­ple myelo­ma in­to re­mis­sion,” said AS­CO Ex­pert Michael S. Sabel in a state­ment. “It’s rare to see such high re­sponse rates, es­pe­cial­ly for a hard-to-treat can­cer. This serves as proof that im­munother­a­py and pre­ci­sion med­i­cine re­search pays off. We hope that fu­ture re­search builds on this suc­cess in mul­ti­ple myelo­ma and oth­er can­cers.”


Pic­tured: Nan­jing, Chi­na on April 27th, 2017 / Shut­ter­stock

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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Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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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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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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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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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.