Seat­tle Ge­net­ics gets ready to launch its sec­ond ADC af­ter scor­ing blad­der can­cer OK with part­ner Astel­las

Seat­tle Ge­net­ics and Astel­las have scored a tru­ly ac­cel­er­at­ed ap­proval to de­ploy their armed an­ti­body in sec­ond-line urothe­lial can­cer, adding an­oth­er promi­nent drug to the list of 2019 OKs that the FDA has been dish­ing out well ahead of sched­ule.

Pad­cev is how en­for­tum­ab ve­dotin will be known on the mar­ket, where it will be a new op­tion for pa­tients with lo­cal­ly ad­vanced or metasta­t­ic urothe­lial can­cer — the most com­mon type of blad­der can­cer — fol­low­ing treat­ment with a PD-1/L1 in­hibitor and a plat­inum-con­tain­ing chemother­a­py. Des­ig­nat­ed a “break­through” ther­a­py by the FDA, it’s the first an­ti­body-drug con­ju­gate to be ap­proved for this ag­gres­sive dis­ease, the com­pa­nies not­ed, and it’s al­so the first prod­uct Seat­tle Ge­net­ics will be bring­ing in­to the mar­ket since Ad­cetris.

Clay Sie­gall

The an­ti­body in en­for­tum­ab ve­dotin hunts down and latch­es on­to Nectin-4, a cell sur­face pro­tein high­ly ex­pressed in blad­der can­cer, then re­leas­es the chemo agent (at­tached with a link­er) to kill the cells.

The ap­proval is the cul­mi­na­tion of a co-de­vel­op­ment pact that dates back to 2007, in which Seat­tle Ge­net­ics and Astel­las are split­ting the costs and prof­its 50/50. But they are not near­ly done.

First, they need to com­plete the con­fir­ma­to­ry Phase III, a 550-pa­tient, place­bo-con­trolled tri­al mea­sur­ing over­all sur­vival as its pri­ma­ry end­point and PFS as one of the sec­on­daries. Reg­u­la­tors gave the green light af­ter re­view­ing da­ta from EV-201, a sin­gle-arm tri­al in­volv­ing 125 pa­tients, in which the con­firmed ob­jec­tive re­sponse rate hit 44% (12% com­plete, 32% par­tial). Me­di­an du­ra­tion of re­sponse was 7.6 months.

Hav­ing rolled out those num­bers at AS­CO this sum­mer, the part­ners sub­mit­ted their fil­ings for ac­cel­er­at­ed ap­proval in Ju­ly, and two months lat­er reg­u­la­tors moved the PDU­FA date up to March 2020 by grant­i­ng pri­or­i­ty re­view and cut­ting the time­frame from 10 months to 6 months.

Then there’s the push to move the ther­a­py up to front­line. Seat­tle Ge­net­ics turned up at ES­MO to show off how their drug com­bined with Keytru­da trig­gered an im­pres­sive 71% over­all re­sponse rate in front­line pa­tients — 32 of 45 pa­tients — who were in­el­i­gi­ble for chemo. The com­plete re­sponse rate came in at 13%. For ref­er­ence, Keytru­da monother­a­py was ap­proved in this set­ting two years ago with an ob­jec­tive re­sponse rate of 29%, in­clud­ing 7% com­plete re­spons­es — and there are con­cerns about low ef­fi­ca­cy for PD-L1 neg­a­tive pa­tients.

The biotech did have to con­tend with some se­ri­ous ad­verse re­ac­tions, in­clud­ing uri­nary tract in­fec­tion, cel­luli­tis, febrile neu­trope­nia, di­ar­rhea, sep­sis, acute kid­ney in­jury, dys­p­nea, and rash. The side ef­fects proved fa­tal in 3.2% of pa­tients.

But for long­time CEO Clay Sie­gall, that won’t hurt their chances in a dis­ease clear­ly still in need of new treat­ments. Seat­tle Ge­net­ics has al­ready hired the sales force for Pad­cev — and they will be gear­ing up for lots more, in­clud­ing breast can­cer drug tu­ca­tinib, now un­der pri­or­i­ty re­view.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.