$20B-plus? Mer­ck keeps rack­ing up PhI­II suc­cess­es, scor­ing on triple neg­a­tive breast can­cer chal­lenge as an­a­lysts dri­ve up peak sales es­ti­mates

Just days af­ter Bris­tol-My­ers Squibb man­aged to sur­prise the an­a­lyst brigade with a Phase III flop for its PD-1 check­point Op­di­vo com­bined with chemo in lung can­cer, Mer­ck’s dom­i­nant team is back with an­oth­er sol­id hit for a par­tic­u­lar­ly tough-to-treat sub­group of breast can­cer pa­tients.

Mer­ck’s Phase III KEYNOTE-522 tri­al con­nect­ed on one of two pri­ma­ry end­points, with their Keytru­da/chemo com­bo elim­i­nat­ing all signs of triple-neg­a­tive breast can­cer — what’s called a patho­log­i­cal com­plete re­sponse — at a sig­nif­i­cant­ly high­er rate than chemo alone, re­gard­less of PD-L1 lev­els in the neo-ad­ju­vant set­ting.

That’s an­oth­er first for Mer­ck, which has been steadi­ly rack­ing up new Phase III suc­cess­es for the mar­quee PD-1. In­ves­ti­ga­tors are con­tin­u­ing the tri­al as they wait to see how Keytru­da/chemo did on event-free sur­vival.

As usu­al, we’ll have to wait for a sci­en­tif­ic con­fer­ence to see the hard num­bers. But it’s im­por­tant to note that Mer­ck’s string of suc­cess­es with Keytru­da is al­so a psy­cho­log­i­cal vic­to­ry that can’t be un­der­es­ti­mat­ed. When Bris­tol-My­ers re­leased its lat­est batch of da­ta on Op­di­vo, the com­pa­ny al­so claimed a suc­cess on Part 1a of the Check­mate -227 tri­al, which met the co-pri­ma­ry end­point of OS, “demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant ben­e­fit for Op­di­vo plus low-dose Yer­voy (ip­il­i­mum­ab) ver­sus chemother­a­py in pa­tients whose tu­mors ex­press PD-L1 ≥1%.”

An­a­lysts weren’t hav­ing it, though, skep­ti­cal that the drug would beat Keytru­da af­ter see­ing the Keynote-189 da­ta. At this stage of the PD-1 bat­tle, Bris­tol-My­ers is as­sumed to come in be­hind Mer­ck.

The string of suc­cess­es has an­a­lysts com­pet­ing in peak sales fore­casts for Keytru­da. Mizuho’s Mara Gold­stein re­cent­ly not­ed:

News of the fail­ure of BMY’s Check­mate-227 Part 2, OP­DI­VO + chemother­a­py in front­line NSCLC to demon­strate an OS ben­e­fit vs. chemother­a­py alone, fur­ther so­lid­i­fies KEYTRU­DA’s dom­i­nance in this mul­ti-bil­lion dol­lar mar­ket op­por­tu­ni­ty, in our view, and is sup­port­ive of our in­vest­ment the­sis. We es­ti­mate that KEYTRU­DA sales will sur­pass $20 bil­lion by 2024, and that KEYTRU­DA will re­main the dom­i­nant check­point in­hibitor in the mar­ket.

Gold­stein added this morn­ing that every­thing is still look­ing rosy for Mer­ck as the com­pa­ny looks to add to its lead in triple neg­a­tive breast can­cer. Plus, the Eu­ro­peans are help­ing with an­oth­er pos­i­tive opin­ion for Mer­ck.

In ad­di­tion to TNBC, MRK al­so an­nounced a pos­i­tive CHMP opin­ion for KEYTRU­DA+IN­LY­TA in 1L RCC based on piv­otal Phase III KEYNOTE-426 da­ta – im­proved OS, PFS, and ORR vs SU­TENT. We think this lends sup­port to our view that KEYTRU­DA should pull far­ther ahead of com­peti­tors as the lead­ing check­point in­hibitor, and is sup­port­ive of our in­vest­ment the­sis.

So­cial im­age: Shut­ter­stock

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Take­da swoops in to buy lit­tle biotech part­ner and its celi­ac drug poised to 'change stan­dard of care'

Having spent three years carefully grooming PvP Biologics and its drug for celiac disease, Takeda is happy enough with the proof-of-concept data to buy it all.

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Bio­gen touts new ev­i­dence from the gene ther­a­py com­pa­ny it wa­gered $800M on

A year ago, Biogen made a big bet on a small gene therapy company. Now they have new evidence one of their therapies could work.

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Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launching its own Phase III trials of remdesivir, the repurposed antiviral that a WHO official called the “one drug right now we think may have real efficacy” against Covid-19 as the novel coronavirus originating from Wuhan, China ravages the world.

Announced just a day after the NIH and the University of Nebraska Medical Center registered their US-based trial online, Gilead’s program will comprise two studies enrolling around 1,000 patients beginning in March. They will recruit primarily in Asian countries but will also include patients from other locations with “high numbers of diagnosed cases,” the company said.

Mi­cro­bio­me Q&A: New study maps the vagi­na's 'op­ti­mal mi­cro­bio­ta' — and its im­pli­ca­tions for bio­phar­ma

The widely-held notion that the “optimal” vaginal microbiota is dominated by one strain of lactic-acid producing bacteria has now been challenged in a new paper, published in Nature Communications on Wednesday, which used advanced gene sequencing methods to map out the most comprehensive gene catalog of the human vaginal microbiome.

Things have changed in the more than 50 years since the concept of vaginal microbiota transplants was proposed and subsequently tainted by a Texas-based gynecologist who transplanted the vaginal fluid of women who had bacterial vaginosis into healthy females, suspecting he had isolated the bacteria responsible for the condition.

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In at least one life-sci hub, gen­der and di­ver­si­ty ini­tia­tives haven’t made a dent

Gender and racial diversity at the top of UK life science companies has hardly budged over the last seven years despite repeated advocacy efforts, according to a new report.

The report, from the recruiting firm Liftstream, found that 14.8% of directors on life sciences boards were women and 21.1% of top executives were women. That’s a modest bump from the 9.8% of directors and 18.1% of executives Liftstream identified in their last report from 2014. The percentage of women CEOs moved from 8% to 9.8%.

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Will a 'risk-of­f' mind­set has­ten cell ther­a­py M&A? Io­vance surges on buy­out chat­ter

Is it time for some cell therapy M&A?

Investors of Iovance Biotherapeutics certainly thought so, sending its stock $IOVA up as much as 40% after Bloomberg reported that the cancer-focused biotech is talking to potential buyers.

While 2019 saw a number of high-profile gene therapy company takeovers — led by Roche’s $4.3 billion bid of Spark as Astellas went for Audentes, Biogen snapped up Nightstar and Vertex absorbed Exonics — large players appeared to prefer partnering on the cell therapy front, particularly when it comes to cancer. Hal Barron put his weight behind Rick Klausner’s startup as he rebuilt GlaxoSmithKline’s cancer pipeline. Takeda turned to MD Anderson to license their natural killer cell therapy.

One less ri­val for Im­muno­vant, as Alex­ion aban­dons FcRn in­hibitor

Less than one year after Alexion parted with $25 million upfront to secure access to a second anti-FcRn asset, it is abandoning the experimental drug. The discontinuation, disclosed at the SVB Leerink Global Healthcare Conference in New York during a fireside chat, bodes well for rival Immunovant.

The drug (ABY-039), partnered for development with Sweden’s Affibody, was forsaken on the basis of early-stage data that was not viewed favorably, Baird and SVB Leerink analysts noted.

Anthony Fauci (AP Images)

UP­DAT­ED: NIH-part­nered Mod­er­na ships off its PhI-ready coro­n­avirus vac­cine can­di­date to a sea of un­cer­tain­ty

Off it goes.

Moderna has shipped the first batch of its mRNA vaccine against SARS-CoV-2 from its manufacturing facility in Norwood, Massachusetts, to the National Institute of Allergy and Infectious Diseases in Bethesda, Maryland, for a pioneering Phase I study.

It’s a hectic race against time. In the 42 days since Moderna selected the sequence they would use to develop their vaccine — a record time, no less — the number of confirmed cases around the world has surged astronomically from a few dozen to over 80,000, per WHO and Johns Hopkins estimates.

The candidate that they came up with, mRNA-1273, encodes for a prefusion stabilized form of the spike protein, which gives the virus its crown shape and plays a key role in transmission. The Coalition for Epidemic Preparedness Innovations, the Oslo-based group better known as CEPI, funded the manufacture of this batch.

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