An­oth­er death mars Ab­b­Vie's lat­est batch of promis­ing da­ta for its star rheuma­toid arthri­tis drug

Ab­b­Vie $AB­BV is one step clos­er to achiev­ing its goal of rolling out a close­ly-watched drug for rheuma­toid arthri­tis as the third late-stage study in the pro­gram de­liv­ered an­oth­er round of promis­ing re­sults. But it’s still be­ing dogged by safe­ty is­sues that may yet come back to haunt the ef­fort.

Re­searchers say that the JAK-1 in­hibitor upadac­i­tinib (bet­ter known as ABT-494) hand­i­ly beat out methotrex­ate as a monother­a­py among pa­tients who weren’t ad­e­quate­ly re­spond­ing to the stan­dard gener­ic. The key fig­ures:

A re­sponse of ACR20/50/70 was achieved by 68/42/23 per­cent of pa­tients re­ceiv­ing 15 mg upadac­i­tinib and 71/52/33 per­cent of pa­tients re­ceiv­ing 30 mg of upadac­i­tinib. That com­pares to 41/15/3 per­cent of pa­tients con­tin­u­ing on methotrex­ate. Twen­ty-eight per­cent and 41% of pa­tients in the 15 mg and 30 mg groups achieved clin­i­cal re­mis­sion, re­spec­tive­ly, com­pared to 8% of pa­tients con­tin­u­ing on methotrex­ate.

Ab­b­Vie man­aged to star­tle in­vestors re­cent­ly with news of the death of two pa­tients in one study. And this time it has to ex­plain that an­oth­er pa­tient in the low-dose arm died of a he­m­or­rhag­ic stroke caused by a rup­tured aneurysm while there was al­so a case of pul­monary em­bolism in the same group. That fol­lowed a re­port in Sep­tem­ber that a pa­tient tak­ing a 30 mg dose ex­pe­ri­enced heart fail­ure and pre­sumed pul­monary em­bolism. In the most re­cent cas­es, both pa­tients had al­ready ex­hib­it­ed risks for these con­di­tions, ac­cord­ing to Ab­b­Vie.

But that didn’t shake its be­lief that they have a block­buster drug on their hands, es­pe­cial­ly as it con­tin­ues to roll out pos­i­tive re­sults. And it’s re­cent­ly added pos­i­tive da­ta on atopic der­mati­tis as well. Com­pa­ny ex­ecs have pegged this drug as a top earn­er ca­pa­ble of bring­ing in $4 bil­lion to $5 bil­lion a year.

Rheuma­toid arthri­tis is a big tar­get for drug de­vel­op­ers. It’s al­so a dif­fi­cult one, as Eli Lil­ly found out when the FDA ini­tial­ly re­ject­ed baric­i­tinib, de­mand­ing a new study. The FDA dropped that de­mand af­ter Scott Got­tlieb was named FDA com­mis­sion­er.

The biggest re­cent ap­proval came for Re­gen­eron and Sanofi, which won an OK to mar­ket sar­ilum­ab af­ter post­ing da­ta demon­strat­ing its abil­i­ty to out­per­form Hu­mi­ra, Ab­b­Vie’s big drug.

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

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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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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Ken Frazier, AP Images

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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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.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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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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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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