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

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.

Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

The story of Amryt Pharma’s candidate for the genetic skin condition epidermolysis bullosa, or EB, will soon enter another chapter.

After the Irish drugmaker’s candidate, dubbed Oleogel-S10 and marketed as Filsuvez, was handed a CRL earlier this year, the company announced in a press release that it plans to submit a formal dispute resolution request for the company’s NDA for Oleogel-S10.

North Carolina Republican Sen. Thom Tillis made a name for himself in the 2020 election cycle as the darling of the pharma industry, accepting hundreds of thousands in campaign contributions, even from the likes of Pfizer CEO Albert Bourla.

Those contributions have led Tillis to attempt to re-write patent laws in pharma’s favor, a move which failed to gain steam in 2019, and request for a third time since January that the FDA should help stop “the false narrative that patent protections are to blame for high drug prices.”