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

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.