#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.

Lessons for biotech and phar­ma from a doc­tor who chased his own cure

After being struck by a rare disease as a healthy third year medical student, David Fajgenbaum began an arduous journey chasing his own cure. Amidst the hustle of this year’s JP Morgan conference, the digital trials platform Medable partnered with Endpoints Studio to share Dr. Fajgenbaum’s story with the drug development industry.

What follows is an edited transcript of the conversation between Medable CEO Dr. Michelle Longmire and Dr. Fajgenbaum, and it is full of lessons for biotech executives charged with bringing the next generation of medicines to patients.

James Collins, Broad Institute via Youtube

UP­DAT­ED: A space odyssey for new an­tibi­otics: MIT's ma­chine learn­ing ap­proach

Drug development is complex, expensive and comes with lousy odds of success — but in most cases, if you make it across the finish line brandishing a product with an edge (and play your cards right) it can be a lucrative endeavor.

As it stands, the antibiotic market is cursed — it harbors the stink of multiple bankruptcies, a dearth of innovation, and is consequently barely whetting the voracious appetites of big pharma or venture capitalists. Enter artificial intelligence — the biopharma industry’s cure-all for the pesky process of making a therapeutic, including data mining, drug discovery, optimal drug delivery, and addressable patient population.

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Gilead los­es two more patent chal­lenges on HIV pill, set­ting up court­room fight in Delaware

Gilead sustained two more losses in their efforts to rid themselves of an activist-backed patent lawsuit from the US government over a best-selling HIV pill.

Urged on by activists seeking to divert a portion of Gilead’s revenue to clinics and prevention programs, the Department of Health and Human Services made a claim to some of the patents for the best-selling HIV prevention drug, Truvada, also known as PrEP. Gilead responded by arguing in court that HHS’s patents were invalid.

Today, the US Patent and Trademark Office ruled that Gilead was likely to lose the last two of those challenges as well. The USPTO ruled against Gilead on the first two patents earlier this month.

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Jim Scholefield via PR Newswire

Mer­ck los­es its chief dig­i­tal of­fi­cer, spot­light­ing tal­ent hunt for the hottest ti­tle in Big Phar­ma

Over the last few years we’ve seen the chief digital officer title become one of the hottest commodities in Big Pharma as global organizations hunt the best talent to sharpen the cutting edge of their tech platforms.

But Merck just discovered how hard it may be to keep them focused on pharma.

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Kathy High (file photo)

Gene ther­a­py pi­o­neer Kathy High has left Spark af­ter com­plet­ing $4.3B union with Roche

Kathy High dedicated the past seven years of her life shepherding experimental gene therapies she’s developed at Children’s Hospital of Philadelphia toward the market as president and head of R&D at Spark Therapeutics. Now that the biotech startup is fully absorbed into Roche — with an FDA approval, a $4.3 billion buyout and a promising hemophilia program to boast — she’s ready to move on.

Roche confirmed her departure with Endpoints News and noted “she will take some well-deserved time off and then will begin a new chapter in a sabbatical at a university.”

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Bank­rupt an­tibi­otics mak­er Ar­a­digm turns to old part­ner/in­vestor for fi­nal $3M fire sale

Grifols once paid Aradigm $26 million for a stake in its inhaled antibiotics. But with Aradigm now in bankruptcy, the Spanish drugmaker is dishing out a final $3.2 million to buy it all.

The fire sale — which comes one year after Aradigm filed for Chapter 11 following a regulatory trifecta for disaster — will see Grifols obtain assets and IP to Apulmiq (formerly Pulmaquin and Linhaliq in Europe), Lipoquin and free ciprofloxacin. In addition to waiving its claims in the bankruptcy case, Grifols also agreed to milestone payments up to $3 million more upon any regulatory approvals.

DB­V's peanut pre­ven­tion patch ap­proach­es key stage of ap­proval process

Almost a year and a half after DBV Technologies pulled its peanut allergy immunotherapy patch from FDA review, the biotech will get their day in court. The FDA has scheduled an advisory committee hearing for May 15.

In the two-horse race to develop the first immunotherapy for peanut allergy, DBV had the early lead, filing an NDA for their patch in 2018. But on December 20 of that year, the company withdrew their application after, they said, meeting with regulators and determining they had not submitted “sufficient detail regarding data on manufacturing procedures and quality controls.” Aimmune filed their BLA 3 days later and won approval as the first immunotherapy for peanuts this month.

Tal Zaks (Moderna via YouTube)

For two decades, a new vac­cine tech­nol­o­gy has been slow­ly ap­proach­ing prime time. Now, can it stop a pan­dem­ic?

Two months before the outbreak, Moderna CMO Tal Zaks traveled from Cambridge, MA to Washington DC to meet with Anthony Fauci and the leaders of the National Institutes of Health.

For two years, Moderna had worked closely with NIH researchers to build a new kind of vaccine for MERS, one of the deadliest new viruses to emerge in the 21st century. The program was one test for a new technology designed to be faster, cheaper and more precise than the ways vaccines had been made for over a century. They had gathered evidence the technology could work in principle, and Fauci, the longtime head of the National Institute of Allergy and Infectious Diseases and a longtime advocate for better epidemic preparedness, wanted to see if it, along with a couple of other approaches, could work in a worst-case scenario: A pandemic.

“[We were] trying to find a test case for how to demonstrate if our technology could rapidly prepare,” Zaks told Endpoints News.

Zaks and Fauci, of course, wouldn’t have to wait to develop a new test. By year’s end, an outbreak in China would short circuit the need for one and throw them into 24/7 work on a real-world emergency. They also weren’t the only ones with new technology who saw a chance to help in a crisis.

An ocean away, Lidia Oostvogels was still on vacation and relaxing at her mother’s house in Belgium when her Facebook started changing. It was days after Christmas and on most people’s feeds, the news that China had reported a novel virus to the World Health Organization blurred into the stream of holiday sweaters and fir trees. But on Oostvogels’s feed, full of vaccine researchers and virus experts, speculation boiled: There was a virus in China, something contained to the country, but “exotic,” “weird,” and maybe having to do with animals. Maybe a coronavirus.

Lidia Oostvogels

“I was immediately thinking like, ‘Hey, this is something that if needed, we can play a role,'” Oostvogels told Endpoints.

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An­to­nio Gual­ber­to starts post-Ku­ra ca­reer at Ei­sai sub­sidiary H3; eF­FEC­TOR co-founder Siegfried Re­ich jumps to Turn­ing Point

→ Days after Kura Oncology announced the departure of co-founder Antonio Gualberto, we finally know where he wound up. Eisai subsidiary H3 Biomedicine has recruited him as CMO to finding the right patients to its four clinical-stage small molecule assets hitting genomic drivers of cancer.

“Challenges of these and many other precision medicine approaches are on one hand technical — a need for robust and precise diagnostics — and on the other hand derived by the challenge to alter standard clinical practice in settings where patient screening, e.g. by tumor DNA sequencing, is not standard practice,” he wrote to Endpoints News on his way back to Boston from Eisai’s Tokyo offices. “Only compelling clinical activity can drive clinicians and pathologists to modify standard clinical practice.”