Boston Bio­med­ical's lead drug fiz­zles in dif­fi­cult-to-treat pan­cre­at­ic can­cer

Months af­ter a com­bi­na­tion of Cel­gene’s Abrax­ane and the chemother­a­py gem­c­itabine stum­bled in a piv­otal study in­volv­ing pan­cre­at­ic can­cer pa­tients who had un­der­gone sur­gi­cal re­sec­tion, a late-stage study test­ing Boston Bio­med­ical’s na­pabu­casin in pa­tients with metasta­t­ic pan­cre­at­ic duc­tal ade­no­car­ci­no­ma — the most com­mon type of pan­cre­at­ic can­cer — has been dis­con­tin­ued.

Pan­cre­at­ic can­cer is rel­a­tive­ly rare but no­to­ri­ous­ly lethal. It is cur­rent­ly the third lead­ing cause of can­cer deaths in the Unit­ed States — and is pro­ject­ed to move in­to the sec­ond slot by 2020, ac­cord­ing to the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter. It is a field lit­tered with drug tri­al fail­ure.

Na­pabu­casin is de­signed to in­hib­it mul­ti­ple path­ways in­volved in can­cer cell stem­ness — self-repli­cat­ing cells that are able to dif­fer­en­ti­ate in­to het­ero­ge­neous can­cer cells and ap­pear to be re­spon­si­ble for the ma­lig­nant growth, re­cur­rence and re­sis­tance to con­ven­tion­al chemother­a­pies.

In the CanStem111P study, na­pabu­casin was added to Abrax­ane and gem­c­itabine and eval­u­at­ed against Abrax­ane and gem­c­itabine alone. The tri­al was ceased due to fu­til­i­ty, as rec­om­mend­ed by an in­de­pen­dent da­ta and safe­ty mon­i­tor­ing board, the com­pa­ny said on Tues­day.

Boston Bio­med­ical, which is a sub­sidiary of Japan’s Sum­it­o­mo Dainip­pon Phar­ma, is al­so test­ing na­pabu­casin in a late-stage tri­al in metasta­t­ic col­orec­tal can­cer, as well as in ear­li­er-stage stud­ies in sol­id tu­mors.

In Jan­u­ary, Ab­b­Vie $AB­BV and part­ner J&J $JNJ re­vealed that a late-stage study of Im­bru­vi­ca com­bined with a pair of chemo drugs could do no bet­ter than the chemo ap­proach alone in pan­cre­at­ic can­cer pa­tients. But the fol­low­ing month, As­traZeneca $AZN and Mer­ck’s $MRK PARP in­hibitor Lyn­parza chalked up a land­mark win in a late-stage pan­cre­at­ic can­cer study.

So­cial im­age: Shut­ter­stock

Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

You can rack up one more high-profile debut effort in the wave of activity forming around cell therapy 2.0. It’s another appealing Bay Area group that’s attracted some of the top hands in the business to a multi-year effort to create a breakthrough. And they have $85 million in hand to make that first big step to the clinic.

Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
Drazan — a J&J Innovation vet with a long record of entrepreneurial endeavors — exited the stage in 2018 when his last mission ended as he stepped aside as president of Grail. It wasn’t long, though, before he was helping out with a business plan for ArsenalBio that revolved around the work of a large group of interconnected scientists supported by the Parker Institute for Cancer Immunology.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 62,400+ biopharma pros reading Endpoints daily — and it's free.