Ar­ray shares surge as sec­ond chap­ter of its PhI­II can­cer com­bo sto­ry ends on an up­beat note

Ar­ray Bio­phar­ma stock got a bounce out of the up­beat as­sess­ment of the sec­ond part of its Phase III study of binime­tinib com­bined with en­co­rafenib, demon­strat­ing their abil­i­ty to sig­nif­i­cant­ly im­prove pro­gres­sion free sur­vival rates for pa­tients with BRAF-mu­tant ad­vanced melanoma. The top-line re­sults lay the foun­da­tion for an NDA, the com­pa­ny adds, which is ex­pect­ed to be de­liv­ered to the FDA this sum­mer.

Ar­ray CEO Ron Squar­er

Ar­ray’s shares $AR­RY surged 20% on Wednes­day as in­vestors and an­a­lysts got a chance to con­sid­er the da­ta on the MEK/BRAF in­hibitors. And while some of the an­a­lysts cov­er­ing the biotech felt that the Phase III news was a def­i­nite plus, there was a feel­ing that a sub­se­quent­ly an­nounced part­ner­ship with Mer­ck in­volv­ing Keytru­da — in which the phar­ma gi­ant will sim­ply con­tribute a quan­ti­ty of their check­point drug for a study — was a bit of a let­down af­ter spec­u­la­tion that a mon­ey deal was in the works.

In Phase III part 2, in­ves­ti­ga­tors looked at a com­bi­na­tion of 45 mg binime­tinib twice dai­ly plus 300 mg en­co­rafenib dai­ly against the con­trol arm of 300 mg en­co­rafenib alone. The com­bi­na­tion achieved a bet­ter me­di­an PFS — 12.9 months vs. 9.2 months; HR = 0.77.

The surge in the stock price helped re­pair some of the dam­age done a cou­ple of months ago when CEO Ron Squar­er had to walk back a promise that they had the da­ta need­ed for its first ap­proval of binime­tinib for NRAS-pos­i­tive melanoma.

Not­ed Leerink’s Michael Schmidt:

Giv­en the pos­i­tive out­come of COLUM­BUS tri­al Part 1 & 2, the like­li­hood of ap­proval of the binime­tinib/en­co­rafenib com­bi­na­tion in mid-2018 re­mains high which was ex­pect­ed by most in­vestors.

Part 1 was a 3-arm tri­al de­sign in 577 pa­tients with a 450 mg en­co­rafenib dose com­bined with binime­tinib com­pared to Zelb­o­raf. The me­di­an PFS rate for Ar­ray’s com­bo was 14.9 months vs. 7.3 months.

Schmidt was less im­pressed with Ar­ray’s deal with Mer­ck to com­bine binime­tinib with Keytru­da for col­orec­tal can­cer in an ear­ly study to test its po­ten­tial.

While this is in­cre­men­tal­ly pos­i­tive for AR­RY, we think a po­ten­tial deal (or even a buy-out of AR­RY) was wide­ly ex­pect­ed by in­vestors.

“The to­tal­i­ty of the COLUM­BUS re­sults, in­clud­ing es­ti­mat­ed pro­gres­sion free sur­vival, ob­jec­tive re­sponse rate, dose in­ten­si­ty and tol­er­a­bil­i­ty of the com­bi­na­tion, pro­vide a strong and con­sis­tent theme across mul­ti­ple end­points, un­der­scor­ing the promise of binime­tinib plus en­co­rafenib as an at­trac­tive treat­ment op­tion for pa­tients di­ag­nosed with BRAF-mu­tant melanoma,” said Kei­th T. Fla­her­ty, di­rec­tor of the Ter­meer Cen­ter for Tar­get­ed Ther­a­py, Mass­a­chu­setts Gen­er­al Hos­pi­tal.

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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RA Cap­i­tal dou­bles down on Sid­dhartha Mukher­jee's vi­sion for a new cell en­gi­neer­ing ap­proach, lead­ing Vor's $110M Se­ries B

Vor Biopharma is muscling up.

CEO Robert Ang, who was reluctant to divulge the headcount when discussing his move from Neon Therapeutics to Vor last August, readily offered that the team has grown from 6 to 50 in less than a year. The biotech is moving to a larger office on Cambridge Parkway Drive in weeks, giving it more space to complete the IND-enabling work and manufacturing scale-up — conducted by a CDMO partner — in preparation for clinical trials planned for the first half of 2021.

Covid-19 roundup: Left out no longer, No­vavax se­cures largest Warp Speed deal yet: $1.6B

It looks like Novavax won’t be left out of Operation Warp Speed after all.

A month after the Gaithersburg, MD biotech saw its shares tumble when it was left off the first reported list of finalists for the White House’s Covid-19 vaccine accelerator, HHS and the Department of Defense have announced a $1.6 billion deal to scale up their Covid-19 candidate. It is the largest deal HHS has announced yet, eclipsing the $1.2 billion deal the administration reached with AstraZeneca in May.

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Cel­lec­tis slammed af­ter pa­tient dies and FDA slaps a hold on their tri­al for an off-the-shelf CAR-T for mul­ti­ple myelo­ma

Cellectis was slammed after the market close on Monday as the biotech reported that the FDA demanded it hit the brakes on their MELANI-01 trial for their off-the-shelf cell therapy UCARTCS1A after one of the patients in the study died of treatment-related cardiac arrest.

The multiple myeloma patient had previously been treated unsuccessfully with various therapies, noted the biotech, and had been given dose level two (DL2) of their allogeneic CAR-T.

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Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Sec­ond PhI­II study for Idor­si­a's sleep drug re­turns pos­i­tive re­sults, but al­so rais­es new ques­tions

Following a successful Phase III study in April showcasing the safety and potential of its new sleep drug, Idorsia posted some mixed news in the second Phase III study, but that won’t stop a planned filing aimed at regulatory approval.

The drug, a dual orexin receptor antagonist (DORA) called daridorexant, was found to significantly improve sleep maintenance and subjective total sleep time in 25 mg doses, replicating results from the first Phase III study. However, improvements in sleep onset and daytime functioning narrowly missed statistical significance, despite numerical consistency with the April study.

UP­DAT­ED: Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA finally granted an accelerated OK for Immunomedics’ Trodelvy, we already got a very strong hint that their confirmatory Phase III study in metastatic triple-negative breast cancer was a success.

That’s because the independent data safety monitoring committee recommended that the trial be stopped early. But just what pointed them to the conclusion was still unclear.

“We do not know the totality of their decision other than it’s pretty evident that the primary endpoint was met; otherwise they could not request to halt the study,” Behzad Aghazadeh, the executive chairman, told Endpoints News at the time.

Shoshanna Shendelman, Applied Therapeutics CEO (Applied Therapeutics)

A lit­tle biotech slaps back at a 'crim­i­nal' short at­tack, vow­ing to pur­sue a pros­e­cu­tion of their case

As short attacks go, Biotech Research Partners’ assault on Applied Therapeutics’ “cherry picked” data and a variety of so-called red flags didn’t cause a whole lot of damage. Ahead of the July 4 holiday, its shares $APLT were dinged and showed signs of quick recovery.

But that didn’t stop an incendiary response, as the biotech swung into action bright and early Monday morning.

Applied Therapeutics accused the authors of the short report of manipulating graphs and figures, misrepresenting data and included factual misrepresentations — all of which added up, in their view, to fraud.

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Bill Haney, Dragonfly CEO (Dave Pedley/Getty Images for SXSW)

A boom­ing Drag­on­fly is tak­ing its TriN­KETs to Copen­hagen as the lat­est Bris­tol My­ers pact spurs ex­pan­sion plans — out­side the US

Bristol Myers Squibb is making a habit out of collaborating with the crew at Dragonfly, adding their 3rd deal in a series that now will take them into newly charted R&D territory. And the fast-growing team at the Cambridge-based biotech is adding a facility in Copenhagen for its next growth spurt, where the government is making it easy to recruit scientists internationally as the U.S. throttles back.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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