Up­dat­ed In­cyte com­bo da­ta for epaca­do­stat/Keytru­da look promis­ing

In­cyte this morn­ing teed up a fresh look at da­ta from its ear­ly-stage study of its close­ly watched IDO1 drug epaca­do­stat com­bined with Mer­ck’s PD-1 check­point ther­a­py Keytru­da. And the up­date — a lit­tle more than week af­ter the first pre­lim­i­nary da­ta were re­port­ed — is en­cour­ag­ing some an­a­lysts to an­tic­i­pate a suc­cess for its piv­otal tri­al of the im­munother­a­py duo, which is now un­der­way.

Steven Stein, In­cyte CMO

In the lead up to the big ES­MO meet­ing this week­end, in­ves­ti­ga­tors for In­cyte $IN­CY say that they tracked pro­gres­sion-free sur­vival rates of 74 per­cent and 57 per­cent af­ter 6 months and 12 months. The study has not yet ma­tured enough for the re­searchers to pin down a me­di­an PFS rate. But the com­plete re­sponse rate has in­creased slight­ly to 26%.

In a state­ment, In­cyte not­ed:

The ob­jec­tive re­sponse rate (ORR) and dis­ease con­trol rate (DCR) re­mained con­sis­tent with the pre­vi­ous­ly pub­lished ab­stract da­ta, at 58 per­cent (12 months) and 74 per­cent (6 months), re­spec­tive­ly. All re­spons­es are con­firmed and on­go­ing (me­di­an fol­low-up among re­spon­ders 56 plus [range of 46 to 90 plus] weeks).

RBC’s Simos Sime­oni­dis of­fered a quick thumbs up on the re­sults this morn­ing, not­ing that the da­ta look good com­pared to ri­val com­bi­na­tions. He ticked off rea­sons for op­ti­mism:

1) af­ter three more months of fol­low-up, since the March 28th da­ta cut­off of the ab­stract, the PFS was not reached; this in­creas­es our con­fi­dence that the com­bo of epaca­do­stat+pem­bro will end up with mPFS that will be su­pe­ri­or of the ipi+ni­vo com­bo (mPFS 11.5 months); 2) the 12- and 6-month PFS dis­cussed in the poster of 57% and 74%, re­spec­tive­ly, com­pare fa­vor­ably with the re­spec­tive PFS of re­sults from tri­als of oth­er im­munother­a­py reg­i­mens; 3) the re­sponse rate re­mained ro­bust and steady, in­clud­ing an ad­di­tion­al pa­tient whose PR be­came a CR; all this while the re­spons­es re­mained durable; 4) 83% (5/6) of melanoma pa­tients treat­ed with 100mg or more of epaca­do­stat were re­spon­ders; 5) the safe­ty of the com­bi­na­tion re­mained be­nign, both in terms of num­bers (19% G3/4) and in terms of types of TEAEs. There are da­ta in the poster about re­spons­es in ad­di­tion­al tu­mors, in­clud­ing lung and kid­ney; how­ev­er, we have a hard­er time hav­ing as strong an opin­ion on them, giv­en the small num­ber of pa­tients test­ed in each tu­mor type. Our key take­away is that epaca­do­stat is a very ac­tive and safe agent in melanoma and this da­ta pre­sen­ta­tion ap­pears to con­firm/re­in­force the com­pa­ny’s de­ci­sion to move in­to the Phase III set­ting.

In­cyte has been run­ning Phase I and Phase II stud­ies of the com­bo in a range of tu­mor types. It launched the Phase III piv­otal tri­al in June, with plans to re­port da­ta in 2018.

These kinds of com­bi­na­tion stud­ies in­volv­ing check­point drugs have be­come all the rage in the on­col­o­gy field. In­cyte in par­tic­u­lar, though, has been busi­ly part­ner­ing with a va­ri­ety of drugs, spurring high hopes that it’s get­ting clos­er to the mar­ket with a lead­ing IDO1 drug. The ther­a­py tar­gets a mech­a­nism used by can­cer cells to avoid an im­mune sys­tem at­tack, and a com­bo with a check­point would seem to of­fer a one-two punch al­low­ing a full-on im­mune re­sponse to can­cer cells.

“We are ex­cit­ed to share fur­ther da­ta with ad­di­tion­al fol­low-up from the Phase 1 por­tion of the ECHO-202 study,” said Steven Stein, In­cyte’s chief med­ical of­fi­cer, in a state­ment. “The durable re­spons­es seen in pa­tients with treat­ment-naïve ad­vanced or metasta­t­ic melanoma reaf­firm the ac­tiv­i­ty of this im­munother­a­py com­bi­na­tion, and we look for­ward to the read-out of ECHO-301, the on­go­ing, piv­otal Phase III tri­al.”

Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

Jay Bradner has recruited a marquee oncology drug researcher into the ranks of the Novartis Institutes for BioMedical Research. Alice Shaw is jumping from prestigious posts intertwined through Mass General, Harvard and Dana-Farber to take the lead of NIBR’s translational clinical oncology group.

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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
Visualisation is a core component of our ability to understand a concept. Ask 10 people to visualise an apple, and each will come up with a slightly different image, some apples smaller than others, some more round, some with bites taken. Acceptable, you say, we can move on to the next part of the story. Now ask 10 people to visualise how HIV’s capsid protein gets arranged into the hexamers and pentamers that form the viral capsid that holds HIV’s genetic material. This request may pose a challenge even to someone with some virology knowledge, and it is that inability to effectively visualise what is going on that holds us back from fully understanding the rest of the story. So how does medical animation help us to overcome this visualisation challenge?

Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

As a potentially powerful flu season looms, so does a big test for Roche and its new flu drug, Xofluza. The Swiss giant just got a small boost in advance of that test as the FDA expanded Xofluza’s indication to include patients at high risk of developing flu-related complications.

Xofluza (baloxavir marboxil) was approved last October in the US, the first landmark flu drug approval in 20 years and a much-needed green light for a company that had watched its leading flu drug Tamiflu get eaten alive by generics. Like its predecessor, the pill offered a reduction in flu symptoms but not a cure.

EMA backs sev­en ther­a­pies, in­clud­ing Mer­ck­'s Ebo­la vac­cine

The first-ever Ebola vaccine is on the precipice of approval after the European Medicine’s Agency (EMA) backed the Merck product in this week’s roster of recommendations.

The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.

Ronald Herb­st fol­lows Med­Im­mune ex­o­dus to Pyx­is CSO post; Jeff God­dard to suc­ceed CEO of AIT Bio­science

→ The outflow of top execs from MedImmune continues to fill the leadership ranks of smaller biotechs. The latest to take off is Ronald Herbst, the head of oncology research, who’s assuming the CSO post at Pyxis Oncology.  

Herbst was part of the old MedImmune organization AstraZeneca CEO Pascal Soriot restructured earlier this year, reorganizing the company and eliminating the storied subsidiary as a separate organization.

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Mer­ck is tak­ing the ax to its US op­er­a­tions, cut­ting 500 jobs in its lat­est re­or­ga­ni­za­tion

Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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UP­DAT­ED: J&J's Xarel­to, Amar­in's Vas­cepa are cost-ef­fec­tive, not bud­get friend­ly — ICER

ICER, an increasingly influential cost-effectiveness watchdog in the United States, has concluded in its review of treatments for cardiovascular disease that while the cost of J&J’s Xarelto and Amarin’s Vascepa meet its benchmark for value pricing — the two treatments will not likely treat as many patients as hoped without surpassing the annual budget threshold calculated by ICER for each therapy.

Mi­rati preps its first look at their KRAS G12C con­tender, and they have to clear a high bar for suc­cess

If you’re a big KRAS G12C fan, mark your calendars for October 28 at 4:20 pm EDT.

That’s when Mirati $MRTX will unveil its first peek at the early clinical data available on MRTX849 in presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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