J&J’s IL-23 star guselkum­ab grabs the spot­light in PhI­II pso­ri­a­sis show­down

J&J has long had high hopes for its an­ti-in­flam­ma­to­ry IL-23 drug guselkum­ab. And to­day in Vi­en­na they de­tailed the first round of Phase III da­ta for se­vere plaque pso­ri­a­sis that ex­plains why.

Philippe Sza­pary, Janssen

In­ves­ti­ga­tors say this drug not on­ly hand­i­ly beat a place­bo, it al­so out­stripped the megablock­buster Hu­mi­ra in key mea­sures of ef­fi­ca­cy. And that will help po­si­tion the phar­ma gi­ant as it starts to line up reg­u­la­to­ry ap­provals for a new ther­a­py that’s like­ly head­ed in­to a heav­i­ly com­pet­i­tive mar­ket.

In the VOY­AGE 1 study, J&J says that the co-pri­ma­ry end­points were met at week 16, with 85.1% of pa­tients re­ceiv­ing guselkum­ab 100 mg at weeks 0 (the start of ther­a­py) and 4 and then every eight weeks achiev­ing cleared (IGA 0) or min­i­mal dis­ease (IGA 1) com­pared with 6.9% of pa­tients re­ceiv­ing place­bo.  Near­ly three-quar­ters of pa­tients re­ceiv­ing guselkum­ab (73.3%) achieved a PASI 90 re­sponse, or near com­plete skin clear­ance, com­pared with 2.9% of pa­tients re­ceiv­ing place­bo.

That’s al­so good news for Mor­phoSys, which part­nered with J&J on the drug.

All ma­jor sec­ondary end­points in VOY­AGE 1 achieved sta­tis­ti­cal sig­nif­i­cance in com­par­isons of guselkum­ab with Hu­mi­ra (adal­i­mum­ab). Here’s the sum­ma­ry:

At week 16, fol­low­ing three in­jec­tions of guselkum­ab and ten in­jec­tions of adal­i­mum­ab, sig­nif­i­cant­ly high­er pro­por­tions of pa­tients re­ceiv­ing guselkum­ab achieved IGA 0/1 and PASI 90 (85.1 per­cent and 73.3 per­cent, re­spec­tive­ly) com­pared with pa­tients re­ceiv­ing adal­i­mum­ab (65.9 per­cent and 49.7 per­cent, re­spec­tive­ly).  At week 24, the pro­por­tion of pa­tients who achieved a PASI 90 re­sponse was sig­nif­i­cant­ly high­er in the guselkum­ab group com­pared with the adal­i­mum­ab group (80.2 per­cent vs. 53.0 per­cent, re­spec­tive­ly).  High­er lev­els of skin clear­ance among the guselkum­ab group con­tin­ued through weeks 24 and 48, with sig­nif­i­cant­ly more pa­tients re­ceiv­ing guselkum­ab achiev­ing IGA 0/1 and PASI 90, as well as mea­sures of full skin clear­ance, as in­di­cat­ed by a 100 per­cent im­prove­ment in PASI score (PASI 100) or an IGA score of 0, com­pared with adal­i­mum­ab.

J&J is look­ing to in­crease its pres­ence in a mar­ket where it’s been build­ing sales for Ste­lara while main­tain­ing an old main­stay, Rem­i­cade, an an­ti-TNF drug like Hu­mi­ra. This new drug is slat­ed to ar­rive as biosim­i­lars for both of the old drugs are an­gling to hit the mar­ket, though Ab­b­Vie has vowed to fight to the bit­ter end over Hu­mi­ra’s patent pro­tec­tion.

“I think (guselkum­ab) ac­tu­al­ly works bet­ter than what we had seen from the da­ta in Phase II,” says Philippe Sza­pary, the VP of im­munol­o­gy clin­i­cal de­vel­op­ment at Janssen, who says both the PASI 90 and clear­ance rates are high­er than the mid-stage re­sults, which may be ex­plained by an ex­tra load­ing dose used in Phase III.

That dif­fer­ence has helped es­tab­lish “good main­te­nance over time” with a rel­a­tive­ly quick on­set for many that could help demon­strate to pa­tients that they’re on the right track.

Even with da­ta from two more late-stage tri­als on track for a lat­er re­lease, Sza­pary says that J&J is on track for reg­u­la­to­ry sub­mis­sions by the end of this year.

“There’s a lot more to come out,” Sza­pary adds, as J&J lays out its case that this drug is bi­o­log­i­cal­ly avail­able to a wide range of pa­tients, from front­line use on to oth­ers.

This fast-mov­ing field has seen plen­ty of dra­ma over the past year. At one point As­traZeneca and Am­gen thought they were on track with bro­dalum­ab, then in­ci­dents of sui­ci­dal ideation drove Am­gen out and per­suad­ed As­traZeneca to sell rights to the drug to a trou­bled Valeant, which won a re­cent pan­el vote.

In the mean­time, Eli Lil­ly made it on­to the mar­ket with Taltz (ix­ek­izum­ab) with No­var­tis out with the first new con­tender, Cosen­tyx. Mer­ck is still in the clin­ic with MK-3222.

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

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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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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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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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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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).