#AACR18 round 1: Mer­ck takes a di­rect swing at Bris­tol-My­ers with ad­ju­vant melanoma da­ta for Keytru­da

CHICA­GO — Mer­ck $MRK came out of its cor­ner swing­ing Sun­day morn­ing, tak­ing a few di­rect jabs at the de­fend­ing cham­pi­on in check­point in­hi­bi­tion as the phar­ma gi­ant en­tered the lat­est I/O ti­tle fight with Bris­tol-My­ers Squibb $BMY at the an­nu­al meet­ing of AACR in Chica­go.

Roger Perl­mut­ter, Mer­ck

Re­searchers for Mer­ck were in Chica­go for the cur­tain open­er in what promis­es to be a bruis­ing brawl be­tween the lead­ers in the PD-1 field over a mar­ket one an­a­lyst has said is worth $3 bil­lion.

In KEYNOTE-054, Mer­ck de­ter­mined that 18 dos­es of Keytru­da pushed post-surgery pa­tients with stage 3 melanoma to a re­cur­rence-free rate of 75.4% com­pared to 61% for a com­par­i­son group get­ting a place­bo. A 43% drop in re­cur­rence rate was some­thing Mer­ck tout­ed as a ma­jor ad­vance for pa­tients.

Mer­ck is look­ing to carve away mar­ket share from Bris­tol-My­ers any way it can. And they’ll have their work cut out in Stage 3 melanoma. Bris­tol-My­ers won an ap­proval to use Yer­voy in this group three years ago, and fol­lowed up with an OK for Op­di­vo last year, mak­ing them the go-to play­er for ad­ju­vant ther­a­py.

Mer­ck, though, didn’t hes­i­tate to make its case in their out­line of the re­sults Sun­day morn­ing. Yer­voy, they note, is no­to­ri­ous­ly tox­ic for pa­tients, who may well pre­fer an al­ter­na­tive. And Op­di­vo? They have an ar­gu­ment there as well.

“Nivolum­ab was more ef­fec­tive and had few­er side ef­fects than ip­il­i­mum­ab, but it is giv­en at a dose of 3 mil­ligrams per kilo­gram every two weeks for up to a year, which is 26 dos­es in to­tal,” not­ed Alexan­der Eg­ger­ment, di­rec­tor gen­er­al of Gus­tave Roussy Can­cer Cam­pus Grand Paris, mak­ing Mer­ck’s case. “Pem­brolizum­ab may prove con­ve­nient to pa­tients and hos­pi­tals be­cause it re­quires few­er out­pa­tient hos­pi­tal vis­its and is giv­en at a flat dose.”

Mer­ck is hunt­ing ap­provals in the US and Eu­rope so they can take that pitch di­rect­ly to physi­cians.

A spokesper­son for Bris­tol-My­ers, though, fol­lowed up with me to note that “the ad­ju­vant melanoma dos­ing for nivolum­ab was up­dat­ed with the Q4W ap­proval and is now ap­proved for flat dos­ing 240 mg every two weeks or 480 mg every four weeks.”

Bris­tol-My­ers won an FDA ap­proval af­ter Check­mate-238 demon­strat­ed that Op­di­vo was bet­ter than Yer­voy in hold­ing back melanoma for post-surgery stage 3 and 4 pa­tients. In that study, the re­cur­rence rate for Op­di­vo at a me­di­an fol­low-up of 18.5 months was 66.4% for Op­di­vo and 52.7% for Yer­voy.

Whats at stake? Ac­cord­ing to Sea­mus Fer­nan­dez at Leerink, about $3 bil­lion. Here’s his com­ment on the -238 re­sults from last sum­mer:

We es­ti­mate the ad­ju­vant melanoma mar­ket will ex­pand PD1 sales by ap­prox­i­mate­ly $3B glob­al­ly. Al­though this like­ly will can­ni­bal­ize sales of Yer­voy in the set­ting (we es­ti­mate cur­rent ad­ju­vant Yer­voy sales at $300-400M), the ex­pan­sion of the mar­ket should add ap­prox­i­mate­ly $1B to BMY’s net im­muno-on­col­o­gy (IO) sales de­spite as­sumed com­pe­ti­tion from MRK’s (MP) Keytru­da (pem­brolizum­ab; an­ti-PD-1).

It’s not just about mon­ey, though. Ever since Bris­tol-My­ers rolled out in front of Mer­ck, Roger Perl­mut­ter’s team has been fo­cused on claim­ing the lead. A key mis­step on lung can­cer at Bris­tol-My­ers gave them an ad­van­tage they’ve been ex­ploit­ing ever since — which we’ll al­so hear more about over the next two days.

This par­tic­u­lar show­down has just be­gun.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Scoop: ARCH’s Bob Nelsen is back­ing an mR­NA up­start that promis­es to up­end the en­tire man­u­fac­tur­ing side of the glob­al busi­ness

For the past 2 years, serial entrepreneur Igor Khandros relied on a small network of friends and close insiders to supply the first millions he needed to fund a secretive project to master a new approach to manufacturing mRNA therapies.

Right now, he says, he has a working “GMP-in-a-box” prototype for a new company he’s building — after launching 3 public companies — which plans to spread this contained, precise manufacturing tech around the world with a set of partners. He’s raised $60 million, recruited some prominent experts. And not coincidentally, he’s going semi-public with this just as a small group of pioneers appears to be on the threshold of ushering in the world’s first mRNA vaccines to fight a worldwide pandemic.

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Isaac Veinbergs, Libra CEO

With $29M in Se­ries A, Boehringer-backed Li­bra looks to tack­le neu­rode­gen­er­a­tion through cel­lu­lar clean­ing

Can the natural process by which cells clean out toxic proteins be harnessed to create potential treatments for neurodegenerative disorders?

That’s the question Libra Therapeutics will be trying to answer, as the new biotech officially launched Wednesday morning with $29 million in Series A financing. The company has three preclinical programs at the ready, with its lead candidate targeting ALS and frontotemporal dementia. But CEO Isaac Veinbergs said he hopes to develop therapies for a wide range of diseases, including Parkinson’s, Alzheimer’s and Huntington’s.

Patrick Enright, Longitude co-founder (Longitude)

As its biotechs hit the pan­dem­ic ex­it, Lon­gi­tude rais­es $585M for new neu­ro, can­cer, ag­ing and or­phan-fo­cused fund

The years have been kind to Longitude Capital. This year, too.

A 2006 spinout of Pequot Capital, its founders started their new firm just four years before the parent company would go under amid insider trading allegations. Their first life sciences fund raised $325 million amid the financial crisis, they added a second for $385 million and then in, 2016, a third for $525 million. In the last few months, the pandemic biotech IPO boom netted several high-value exits from those funds, as Checkmate, Vaxcyte, Inozyme and Poseida all went public.

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Gene Wang, Immetas co-founder and CEO (file photo)

Im­metas Ther­a­peu­tics nabs $11M Se­ries A to nar­row their bis­pe­cif­ic work tar­get­ing in­flam­ma­tion in age-re­lat­ed dis­eases

How does a biotech celebrate its two-year anniversary? For Immetas Therapeutics, it’s with an $11 million Series A round and a game plan to fight age-related disease.

Co-founders Gene Wang and David Sinclair came together years ago around the idea that inflammation is the ultimate process driving age-related illnesses, including cancer. The duo launched Immetas in 2018 and packed the staff with industry experts. Wang, who says he’s always had an entrepreneurial spirit, has held lead roles at Novartis, GSK, Bristol Myers Squibb and Merck. He’s worked on blockbuster drugs like Humira, Gardasil, Varubi and Zolinza. And now, he’s channeling that spirit as CEO.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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