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.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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Hal Barron, GSK R&D chief (Endpoints News)

Hal Bar­ron gam­bles $625M cash on high-wire TIG­IT act, throw­ing Glax­o­SmithK­line in­to heat­ed race and com­plet­ing next-gen I/O trin­i­ty

Count Hal Barron and GlaxoSmithKline in for the TIGIT fight.

The stakes are as high as the risks: While a growing pack of Big Pharma rivals is lending credence to the hypothesis that TIGIT will be the next big immune checkpoint and cancer drug target, the first clinical trials have shown response rates that can be described as modest at best. But Barron’s bet is on the whole “axis” that the receptor sits on, with an eye on testing its new anti-TIGIT antibody not just in combo with PD-1 but also in triplets.

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Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Geoffrey Porges, SVB Leerink

Top an­a­lyst maps a rocky road for Ver­tex — un­less they adopt a $10B M&A cam­paign to save the pipeline

After repeatedly poking Vertex $VRTX execs with pointed criticism of their R&D strategy, top SVB Leerink analyst Geoffrey Porges is now turning up the heat to a full-scale roasting.

In a note out early Monday morning, Porges spotlights the impact of Vertex’s recent follow-up failure on AATD — their treatment hit the endpoint but missed on commercial prospects — rewriting his recommended scenario for CEO Reshma Kewalramani as she grapples with the setback.

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Lynn Fitch, Mississippi Attorney General (Rogelio V. Solis/AP Images)

Mis­sis­sip­pi sues Eli Lil­ly, Sanofi and No­vo over in­sulin prices as in­ter­change­able biosim­i­lars may ar­rive soon

Mississippi Attorney General Lynn Fitch last week sued the top three insulin manufacturers, which collectively cover almost the entire US insulin market, alleging that they’ve colluded to raise their prices in lockstep, and in some cases by more than 1,000% for drugs that are decades old.

“Because of Manufacturer Defendants’ collusive price increases, nearly a century after the discovery of insulin, diabetes medications have become unaffordable for many diabetics,” the lawsuit says.

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Andrew Hopkins, Exscientia CEO

Ex­sci­en­tia spends Soft­Bank's cash in bid to edge out AI ri­vals

Exscientia is sprinting to win the great AI biotech race.

The UK company, having long labored on small discovery deals with large pharmas, raised up to $525 million in a Series D led by the infamous Japanese conglomerate SoftBank in April and followed it up less than a month later with a Bristol Myers Squibb deal that paid $50 million cash and $1.2 billion in milestones.

Now, the Oxford spinout is splurging on a shiny new tool. On Monday they announced they purchased the three-year-old molecule-screening biotech Allcyte, a longtime collaborator, for $60.6 million in cash and stock.

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As­traZeneca's Covid-19 an­ti­body cock­tail miss­es the mark in pre­vent­ing symp­toms post-ex­po­sure

As the field for monoclonal antibody treatments of Covid-19 grows more crowded, AstraZeneca has announced a study of its own cocktail AZD7442 did not meet its main goal of preventing symptomatic Covid-19.

The company’s long-acting antibody combo was used in a trial with unvaccinated adults about the age of 18 with confirmed exposure. AZD7442 reduced the risk by just 33%, a figure that was not statistically significant.