In­cyte keeps the AS­CO spot­light fo­cused on its close­ly-watched IDO1 drug epaca­do­stat

Steven Stein

CHICA­GO — Typ­i­cal­ly, when you up­date your ear­ly-stage da­ta with a cou­ple of new com­plete re­spons­es to re­port, the bio­phar­ma world finds oth­er things to fo­cus on. But if you’re In­cyte, with a $27 bil­lion mar­ket cap $IN­CY cen­tered on its lead IDO1 ther­a­py epaca­do­stat, the bio­phar­ma world will make an ex­cep­tion for you.

So it was on Sat­ur­day at AS­CO, when In­cyte ad­just­ed the aba­cus on its non-small cell small com­bo lung can­cer study for epaca­do­stat and Keytru­da, mov­ing 2 of 14 re­spons­es re­port­ed re­cent­ly in its AS­CO ab­stract out of the par­tial side to the com­plete re­spons­es line­up.

That’s an­oth­er pos­i­tive note, and “it’s sort of a big deal in the set­ting,” In­cyte CMO Steven Stein tells me.

In­cyte is en­cour­aged by the im­prove­ment as it tracks dura­bil­i­ty of the ear­ly-stage da­ta. And while in­ves­ti­ga­tors aren’t mak­ing any pre­dic­tions of what they’re go­ing to see from here, says Stein, “it’s un­like­ly to get worse; it can on­ly get bet­ter.”

The to­tal re­sponse rate stayed the same in this study: 35%. That’s key here as the clos­est com­pa­ra­ble monother­a­py da­ta In­cyte fol­lows is an 18% and 20% re­sponse rate (for squa­mous on­ly lung can­cer) for ei­ther Keytru­da or Op­di­vo, re­spec­tive­ly.

In­cyte’s fo­cus, along with the rest of the grow­ing crowd fol­low­ing this com­pa­ny, will trans­fer now to the Phase III stud­ies that In­cyte is ham­mer­ing out with the FDA, Mer­ck and Bris­tol-My­ers Squibb.

Stein says that re­sponse rate they’ve seen could im­prove as you move up to front-line use for treat­ment naive pa­tients.

“Typ­i­cal­ly you ex­pect high­er re­sponse rates in the first-line set­ting in im­muno-on­col­o­gy,” says Stein, who fol­lowed In­cyte CEO Hervé Hop­penot out of No­var­tis On­col­o­gy to the biotech. “This has been borne out across the board as you go from first- to third-line.”

Stein is re­luc­tant to get in­to too much de­tail on how the late-stage stud­ies will play out. That has to be worked out with reg­u­la­tors. But he notes that in lung can­cer, where Mer­ck re­cent­ly won ap­proval for a land­mark Keytru­da/chemo com­bo for first-line use, you have three key pop­u­la­tions: High PD-L1 ex­pressers, low PD-L1 ex­pressers and sig­nif­i­cant­ly now all com­ers.

“We ex­pect mech­a­nis­ti­cal­ly to en­hance the check­points,” adds Stein. “Where they have largest ef­fect we would ex­pect to have our largest ef­fect and en­hance those.”

In­cyte has its own PD-1 drug, part­nered with the Chi­nese biotech Jiang­su Hen­grui Med­i­cine with a $25 mil­lion up­front and $770 mil­lion in mile­stones. But Stein says that in­ves­ti­ga­tors re­cent­ly not­ed ev­i­dence of he­man­gioma — non­cancer­ous red spots that ap­pear on the skin. It’s large­ly a “cos­met­ic” is­sue, he notes. But when there are “north of 30 pub­licly an­nounced” check­point drugs which are all sim­i­lar, it rais­es a ques­tion whether it might dif­fer­en­ti­ate the drug in a neg­a­tive way.

In­cyte is ag­nos­tic about its al­liances with the check­point lead­ers. It will fol­low the da­ta wher­ev­er they lead.

“We feel it’s im­por­tant to own one,” says Stein. “We think it will re­main a back­bone of dou­blet and maybe triplet treat­ment.”

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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Susan Galbraith, AstraZeneca EVP, oncology R&D

Catch­ing up with Bris­tol My­ers and Mer­ck, As­traZeneca de­clares neoad­ju­vant win for PD-L1/chemo com­bo

When AstraZeneca started the Phase III AEGEAN trial for Imfinzi in 2018, it was, alongside several Big Pharma brethren, hoping to push the use of PD-(L)1 therapies into earlier lines of treatment. Three and a half years later, the British drugmaker has nabbed promising data in a type of lung cancer.

Topline results from an interim analysis showed that adding Imfinzi to chemotherapy before surgery spurred a “statistically significant and meaningful” improvement in pathologic complete response for patients with resectable non-small cell lung cancer compared to chemotherapy alone.

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Nassim Usman, Catalyst Biosciences CEO

Fac­ing set­backs for months and an ac­tivist at­tack, Cat­a­lyst Bio­sciences pre­pares to call it quits

After downsizing for several months, Catalyst Biosciences is getting ready to tap out.

The San Francisco biotech announced Wednesday that it would be liquidating and distributing cash back to shareholders, with total proceeds expected to reach $65 million. Catalyst intends to return the money “as soon as practicable,” the company said, as it has ceased all R&D activities, CEO Nassim Usman said in a statement.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

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Bio­haven takes mi­graine cam­paign to pa­tients' Twit­ter feeds, months ahead of Pfiz­er takeover

Two weeks ago, Biohaven hit an all-time high in weekly Nurtec prescriptions. CEO Vlad Coric attributes at least some of that success to a new interactive Twitter campaign that encourages patients to free their feed of potential migraine triggers.

Earlier this month, Biohaven in partnership with Twitter launched the #RelieveYourFeed campaign that allows users to customize their app settings based on their migraine triggers.