Mer­ck pre­views an ear­ly hit with Keytru­da com­bo for kid­ney can­cer, putting more pres­sure on ri­val Bris­tol-My­ers

Mer­ck ar­rived at ES­MO in style, fronting their ap­pear­ance in Mu­nich with pos­i­tive — and very ear­ly — com­bi­na­tion da­ta for their PD-1 check­point star Keytru­da in treat­ing front­line kid­ney can­cer.

Re­searchers com­bined Keytru­da with Pfiz­er’s In­ly­ta for KEYNOTE-426 and came away with an ear­ly win on both pro­gres­sion-free and over­all sur­vival, along with a key sec­ondary in beat­ing Su­tent in a head-to-head show­down.

The hard da­ta will come lat­er at an­oth­er con­fer­ence, but the FDA gets to see it first as Mer­ck hus­tles for yet an­oth­er sup­ple­men­tal ap­proval for its fran­chise play­er.

Mer­ck’s team called this a win at a very ear­ly point, catch­ing an­a­lysts like Ever­core ISI’s Umer Raf­fat by sur­prise. The fi­nal da­ta weren’t ex­pect­ed be­fore the 2019/20 time frame. But Mer­ck has been pulling out all stops in its suc­cess­ful quest to push ahead of Bris­tol-My­ers Squibb, who now faces fresh com­pe­ti­tion on this front as well for its com­bi­na­tion of Op­di­vo-Yer­voy.

Bris­tol-My­ers won an OK for first line kid­ney can­cer ear­li­er in the year. But then the CHMP in Eu­rope turned thumbs down, say­ing the com­pa­ny had not “demon­strat­ed the con­tri­bu­tion of com­po­nents suf­fi­cient­ly well.” Bris­tol-My­ers is ap­peal­ing while Mer­ck looks to cut ahead of the line yet again.

“This marks the first time that com­bi­na­tion treat­ment with an an­ti-PD-1 ther­a­py has achieved the dual pri­ma­ry end­points of over­all sur­vival and pro­gres­sion-free sur­vival as first-line ther­a­py in ad­vanced re­nal cell car­ci­no­ma,” said Mer­ck R&D chief Roger Perl­mut­ter, who’s been over­see­ing a grid of hun­dreds of stud­ies for their PD-1. “Few­er than 10 per­cent of those di­ag­nosed with ad­vanced re­nal cell car­ci­no­ma sur­vive for five years, and hence there is sig­nif­i­cant need for im­proved ther­a­pies for this dis­ease.”

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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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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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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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).

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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