A speedy FDA of­fers light­ning re­view and quick OK for the lat­est PD-1 from Re­gen­eron and Sanofi

The FDA re­al­ly didn’t need un­til the end of Oc­to­ber to de­cide on whether it want­ed to ap­prove cemi­plimab, the world’s 6th PD-1/L1 from Sanofi and Re­gen­eron. Reg­u­la­tors flagged it through on Fri­day evening, hap­py to see the field crowd up as a top col­lab­o­ra­tion team cruised to a win ahead of a pri­or­i­ty re­view dead­line.

The drug will be sold as Lib­tayo for ad­vanced cu­ta­neous squa­mous cell car­ci­no­ma. In­ves­ti­ga­tors came up with a 46.3% ORR for ad­vanced CSCC in their key study and plan to sell the ther­a­py with a whole­sale ac­qui­si­tion cost of $9,100 per three-week treat­ment cy­cle. Pa­tients will be el­i­gi­ble for co­pay sup­port.

“These pa­tients of­ten have ad­vanced dis­ease with lim­it­ed treat­ment op­tions, and are of­ten el­der­ly with co­mor­bidi­ties,” said on­col­o­gist Dan­ny Rischin about the da­ta. “Some pa­tients on the tri­al were on­ly es­ti­mat­ed to live for a few months, and are back to liv­ing nor­mal lives at near­ly 2 years now. It’s quite re­mark­able com­pared with the op­tions pre­vi­ous­ly.”

Re­gen­eron and Sanofi both will­ing­ly an­ted up $1 bil­lion re­cent­ly to help ac­cel­er­ate their work here, look­ing to make a splash in a field that has been clear­ly dom­i­nat­ed by mega block­busters from Mer­ck and Bris­tol-My­ers Squibb.

Both com­pa­nies still have high hopes for the over­all mar­ket op­por­tu­ni­ty, as a line­up of ma­jors that al­so in­cludes the likes of Roche, As­traZeneca and Pfiz­er/Mer­ck KGaA grap­ple with the two top play­ers for a slice of a block­buster mar­ket. Re­gen­eron in­ves­ti­ga­tors in par­tic­u­lar high­light­ed their be­lief that while there may be sig­nif­i­cant sim­i­lar­i­ties in some of these ri­val drugs, they be­lieve that cemi­plimab in par­tic­u­lar will stand out as a top-ranked PD-1, with clear ad­van­tages over the 3 PD-L1 drugs in the mar­ket.

One thing is for cer­tain, though. This won’t be the last of the PD-1/L1 crowd.

The Can­cer Re­search In­sti­tute ran a study that found 164 PD-1/L1s in the pipeline, from pre­clin­i­cal through mar­ket­ing stages. No­var­tis has one in de­vel­op­ment sole­ly for in-house use. And we may find a few thrown in as low-priced com­modi­ties, mak­ing check­point 2.0 more im­por­tant than ever for the lead­ers.

The speedy re­view comes as no great sur­prise. The FDA has deep ex­pe­ri­ence in this field, and has helped hus­tle along new play­ers. It al­so marks the agency’s 41st new drug OK for their list, with 3 months to shoot far past last year’s 46.

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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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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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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