Seat­tle Ge­net­ics has se­cured a speedy re­view of its sec­ond armed an­ti­body, cour­tesy of the FDA.

The com­pa­ny’s ‘break­through’ Astel­las-part­nered drug — en­for­tum­ab ve­dotin — has pro­cured pri­or­i­ty re­view from the US reg­u­la­tor, af­ter da­ta showed it helped pa­tients with a stub­born type of blad­der can­cer.

The drug-in­duced a 44% ob­jec­tive re­sponse rate (ORR) in 128 pa­tients whose dis­ease had pro­gressed de­spite treat­ment with both plat­inum-con­tain­ing chemother­a­py and a check­point in­hibitor in the one-arm EV-201 study. About 12% of the pa­tients ex­pe­ri­enced a com­plete re­sponse, Seat­tle Ge­net­ics dis­closed at AS­CO this June.

A mar­ket­ing ap­pli­ca­tion for the drug has al­ready been sub­mit­ted — and a late-stage tri­al de­signed to con­firm the drug’s safe­ty and ef­fi­ca­cy in this pa­tient pop­u­la­tion is on­go­ing.

The FDA is ex­pect­ed to make its de­ci­sion on the drug by March 15, the com­pa­ny said on Mon­day. In a note pub­lished in Ju­ly, Stifel an­a­lysts es­ti­mat­ed that en­for­tum­ab ve­dotin will gen­er­ate North Amer­i­ca sales of about $367 mil­lion in 2024.

Clay Sie­gall Seat­tle Ge­net­ics

The part­ners are test­ing the drug in com­bi­na­tion with Mer­ck’s $MRK Keytru­da and with chemother­a­py, and as part of a triplet com­bo. The idea is to al­so push for ap­proval in the front­line set­ting and gen­er­ate block­buster sales, Seat­tle Ge­net­ics’ chief Clay Sie­gall told End­points News at AS­CO.

AD­Cs are a class of ther­a­peu­tics in which a can­cer-killing tox­in is at­tached to a spe­cif­ic an­ti­body us­ing a biodegrad­able link­er. De­signed to min­i­mize the ef­fects of the chemother­a­py on healthy cells while max­i­miz­ing tu­mor cell death, the tech­nol­o­gy is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get. Seat­tle Ge­net­ics $SGEN al­ready has one ADC on the mar­ket, Ad­cetris, and a slate of oth­ers in de­vel­op­ment.

En­for­tum­ab ve­dotin (EV) tar­gets Nectin-4, a cell ad­he­sion mol­e­cule seen in a range of sol­id tu­mors.

Urothe­lial can­cer is the most com­mon type of blad­der can­cer. About 80,470 new cas­es of blad­der can­cer are ex­pect­ed to be di­ag­nosed this year, and it is an­tic­i­pat­ed that 17,670 blad­der can­cer deaths will oc­cur in 2019, ac­cord­ing to Amer­i­can Can­cer So­ci­ety es­ti­mates. Da­ta sug­gest most pa­tients do not re­spond to check­point in­hibitors af­ter a plat­inum-con­tain­ing ther­a­py has failed as an ini­tial treat­ment for ad­vanced dis­ease, and there are no oth­er ap­proved op­tions for pa­tients once these two lines of treat­ment have been ex­haust­ed.

So­cial im­age: Clay Sie­gall, Life Sci­ence Wash­ing­ton via YouTube

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

Early in my career, as a medical resident, I saw first-hand the enormous challenges faced by children and adults with sickle cell disease (SCD), a genetic blood disorder that historically has lacked adequate treatment options. People living with this life-long disease are mainly those with ancestors from sub-Saharan Africa, as well as people of Hispanic, South Asian, Southern European and Middle Eastern descent. These patients suffer from devastating physical symptoms, including progressive, eventually fatal, organ damage and excruciating pain. In addition, they encounter emotional, mental and social burdens – non-physical aspects of living with SCD that also take a serious toll on patients and their caregivers.

On Monday, we held our fourth annual #JPM event — and the team hit a key milestone that I’d like to share with the entire Endpoints News audience: We live-streamed the conversation and had nearly triple the number of executives watching online than we had in the sold-out crowd of 320.

For a media company on a mission to connect the biopharma world in bigger and better ways, we’re proud of how we were able to extend the reach of our franchise event. Paid subscribers were given access to the stream in real time, and now, two days later, we’re opening it up to everyone in this post.

Editor’s Note: Endpoints News is reporting live from #JPM20 after kicking things off with an action-packed event, which you can replay here. What follows is a stream of tidbits we have collected while wandering around Union Square in San Francisco. Check back in throughout the week for updates by John Carroll and Jason Mast.

SAN FRANCISCO — A year ago Takeda CEO Christophe Weber and R&D chief Andy Plump arrived at JP Morgan right on the heels of closing their big Shire buyout. Now they’re back after shaking up the portfolio, boosting R&D spending by about 50% to $4.5 billion and adjusting the pipeline — a task which isn’t quite finished yet.