Roger Dansey, Seagen CEO (via Merck)

As Mer­ck buy­out buzz heats up, Seagen touts a pos­i­tive up­date on their Pad­cev/Keytru­da com­bo

Most of the news at Seagen these days re­volves around hot buzz about a po­ten­tial $40 bil­lion-plus Mer­ck buy­out. But to­day the fo­cus has shift­ed to an ex­per­i­men­tal com­bo that us­es the phar­ma gi­ant’s big PD-1 can­cer drug Keytru­da.

Ex­ecs at Seagen and their part­ner Astel­las post­ed pos­i­tive top-line num­bers for a com­bi­na­tion of Pad­cev and Keytru­da, not­ing a con­firmed over­all re­sponse rate of 64.5% for front­line urothe­lial can­cer pa­tients who are in­el­i­gi­ble for cis­platin.

Me­di­an du­ra­tion of re­sponse had not yet been achieved.

This was the EV-103 Co­hort K ex­pan­sion tri­al, which saw a dip in the ORR rate from the 73% tracked in Co­hort A. But sev­er­al an­a­lysts to­day were quick to of­fer the re­sults at least a ten­ta­tive thumbs-up, while not­ing that a num­ber of ques­tions have to be an­swered be­fore they can ful­ly de­ter­mine the com­bo’s val­ue.

An­drew Berens at SVB Se­cu­ri­ties took a look at the da­ta and not­ed:

We be­lieve the re­sults were gen­er­al­ly ex­pect­ed to come down in larg­er pa­tient num­bers, but still came in above what we viewed as the bar for suc­cess (ORR in the low 60%’s). Me­di­an du­ra­tion of treat­ment was un­reached, and treat­ment ex­po­sure in the tri­al was not dis­closed. More im­por­tant­ly, me­di­an cy­cles of Pad­cev us­age were un­re­port­ed, a key met­ric giv­en that pe­riph­er­al neu­ropa­thy ap­pears to lim­it us­age of Pad­cev in some set­tings, and is like­ly cu­mu­la­tive.

Berens came up with his own set of out­stand­ing ques­tions.

(T)he an­nounce­ment was sparse on key ef­fi­ca­cy de­tails like: 1) du­ra­tion of Pad­cev us­age (num­ber of cy­cles); 2) dura­bil­i­ty met­rics (me­di­an du­ra­tion of re­sponse [DOR] not reached), and 3) the ef­fi­ca­cy of Pad­cev monother­a­py arm. We think that the ab­sence of in­clu­sion of the monother­a­py da­ta in the press re­lease sug­gests the ac­tiv­i­ty/du­ra­tion is like­ly mean­ing­ful­ly less than com­bi­na­tion, im­por­tant to some in­vestors spec­u­lat­ing on the like­li­hood of op­tion­al­i­ty, which would be large­ly dri­ven by syn­er­gies with check­point agents.

Pad­cev is Seagen’s sec­ond best-sell­ing drug, with $340 mil­lion in sales last year. Com­pa­ny ex­ecs have been fo­cused on this new com­bo tri­al as a ma­jor cat­a­lyst for big­ger sales ahead, if they can par­lay the da­ta in­to an ac­cel­er­at­ed ap­proval. But the ju­ry is still out on that score.

Count Boris Peak­er at Cowen, though, as an­oth­er in­ter­est­ed on­look­er. He’s ready to give the com­bo sol­id odds for an ap­proval in the ear­ly part of next year, push­ing fran­chise rev­enue to $665 mil­lion next year.

Ah­san Arozul­lah

“Ap­prox­i­mate­ly half of pa­tients with ad­vanced urothe­lial car­ci­no­ma are in­el­i­gi­ble for cis­platin-based chemother­a­py,” said Ah­san Arozul­lah, SVP and head of de­vel­op­ment ther­a­peu­tic ar­eas at Astel­las, in a press re­lease. Cis­platin-in­el­i­gi­ble pa­tients typ­i­cal­ly have few treat­ment op­tions and a poor prog­no­sis.

Pad­cev is the first an­ti­body-drug con­ju­gate of its kind, the pair says, and works by at­tach­ing it­self to Nectin-4, a cell sur­face pro­tein high­ly ex­pressed in blad­der can­cer. A spe­cif­ic chemother­a­py agent is then re­leased to kill the cells. The com­pa­nies will dis­cuss the re­sults with reg­u­la­to­ry au­thor­i­ties.

Mean­while, Mer­ck is in ad­vanced talks to buy Seagen for about $40 bil­lion or more, or above $200 per share, ac­cord­ing to Wall Street Jour­nal re­ports. The lat­est word from the Jour­nal was that any move would like­ly come af­ter their earn­ings call Ju­ly 28. If the deal goes through, it could be one of the biggest trans­ac­tions in re­cent his­to­ry.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.