Seat­tle Ge­net­ics gets a PhI­II win for Ad­cetris, but shares slide as frets linger

Seat­tle Ge­net­ics $SGEN has had a rough Q2 as its lead ex­per­i­men­tal ther­a­py was put back on hold, forc­ing in­ves­ti­ga­tors to scrap Phase III short­ly af­ter the biotech had to drop a deal with Im­munomedics. But it’s wind­ing up the quar­ter with a ma­jor win in its fa­vor, post­ing a hit in its close­ly-watched Ech­e­lon-1 study for front­line Hodgkin lym­phoma.

The big biotech says that its flag­ship ther­a­py, Ad­cetris, com­bined with a trio of stan­dard drugs beat a 4-drug main­stay cock­tail ther­a­py in front­line Hodgkin dis­ease for mod­i­fied pro­gres­sion-free sur­vival over a lengthy two-year stretch. The Ad­cetris pack­age ex­clud­ed bleomycin, which has been linked to a high­er rate of lung tox­i­c­i­ty and was used in the 4-drug com­bo con­trol.

Clay Sie­gall

Com­pa­ny ex­ecs tell me that they’re prep­ping an FDA ap­pli­ca­tion an­tic­i­pat­ed for lat­er this year. Seat­tle Ge­net­ics con­trols the US and Cana­di­an mar­kets for Ad­cetris, with its part­ner Take­da tak­ing on the rest of the world.

An­a­lysts have been watch­ing this key cat­a­lyst close­ly, look­ing to see if Seat­tle Ge­net­ics has a good chance of sig­nif­i­cant­ly ex­pand­ing its rev­enue from Ad­cetris. The an­swer to that would ap­pear to be a con­di­tion­al yes, based on the biotech’s top-line da­ta.

The Ad­cetris com­bo hit a two-year mod­i­fied PFS rate of 82.1% com­pared to 77.2% in the con­trol arm — a 4.9 point, or 6%, im­prove­ment. That’s sta­tis­ti­cal­ly sig­nif­i­cant, but not the wider, dou­ble-dig­it mar­gin that the bulls have been look­ing for, ac­cord­ing to a re­cent deep dive on this sub­ject from Leerink.

An­a­lysts there have not­ed that with­out a 10%-plus mar­gin in its fa­vor, pay­ers may just stick with the cheap­er stan­dard. The dif­fer­ence could amount to hun­dreds of mil­lions of dol­lars for Seat­tle Ge­net­ics by 2025.

In­vestors weren’t hap­py with the num­bers. Seat­tle Ge­net­ics’ shares dropped 11% as the da­ta sank in on Wall Street. Some of the ear­ly re­ac­tions on Twit­ter were al­so crit­i­cal.

You al­ways pre­fer a bet­ter re­sponse, Seat­tle Ge­net­ics CEO Clay Sie­gall told me in a pre­view of the an­nounce­ment. But this marks a clear win for pa­tients and a plus for the com­pa­ny as Sie­gall re­mains de­ter­mined to make Ad­cetris a bil­lion dol­lar-plus block­buster.

“We did a pret­ty au­da­cious tri­al,” Sie­gall says. “Peo­ple said you’re try­ing to build on some­thing that al­ready looks pret­ty good…There wasn’t a lot of head­room.”

Ad­cetris and the com­bo de­liv­ered a 23% re­duc­tion in risk of pro­gres­sion, he says, build­ing the num­ber of durable re­spons­es among pa­tients who are of­ten di­ag­nosed in their twen­ties and thir­ties. In ad­di­tion, he says, doc­tors clear­ly want to elim­i­nate bleomycin and the risk of lung tox­i­c­i­ty, of­fer­ing an­oth­er ad­van­tage for Ad­cetris.

Seat­tle Ge­net­ics added that an in­ter­im look at over­all sur­vival rates — the sec­ondary to watch — ap­peared to be “trend­ing” in its fa­vor at the in­ter­im point. That’s not un­ex­pect­ed. It will prob­a­bly take 4 years to reach a con­clu­sion on OS, says the CEO, in this pop­u­la­tion.

There’s al­so like­ly to be con­tin­ued chat­ter about in­ves­ti­ga­tors’ use of “mod­i­fied” PFS in the study.

Rather than stick with track­ing the time un­til dis­ease pro­gres­sion, re­searchers mod­i­fied the end­point to in­clude the use of an ad­di­tion­al ther­a­py for pa­tients who had a “cer­tain lack of re­sponse,” says the CEO, who added that that is a sim­plis­tic de­f­i­n­i­tion. If ap­proved, says Sie­gall, this would be Ad­cetris’ 5th OK, with ear­li­er ex­pan­sions help­ing to con­tin­ue to widen the mar­ket for their drug.

Sie­gall al­so says that the pipeline at Seat­tle Ge­net­ics con­tin­ues to of­fer some stel­lar prospects for beef­ing up its port­fo­lio of mar­ket­ed drugs. The biotech re­mains ready to do new deals, he says, but on­ly on an ‘as want­ed’ ba­sis as op­posed to an ‘as need­ed’ ba­sis.

“We think Ad­cetris has an ex­cel­lent chance of be­ing a bil­lion-dol­lar drug in the US,” says the CEO. The next year will pro­vide some in­sights in­to just how like­ly that is.

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.

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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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.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

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.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

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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