Clay Siegall, Seagen CEO (Life Science Washington via YouTube)

Seat­tle Ge­net­ics? Not any­more. The biotech has short­ened its name to Seagen to il­lus­trate glob­al ex­pan­sion

Would a Seat­tle Ge­net­ics by any oth­er name smell as sweet? We’re about to find out.

The biotech an­nounced Thurs­day it’s chang­ing its name to Seagen, cap­ping off what’s been a 12-month pe­ri­od in which it closed a $4.5 bil­lion deal with Mer­ck and saw two drugs get FDA ap­proval. Seagen is al­so keep­ing the same Wall Street tick­er — $SGEN.

CEO Clay Sie­gall said the com­pa­ny made the change to rep­re­sent its ex­pand­ing glob­al op­er­a­tions.

“Our goal is to help can­cer pa­tients around the world,” Sie­gall said. “It is, to us, bet­ter to be re­flect­ed as a biotech­nol­o­gy com­pa­ny that makes can­cer prod­ucts for the globe, and as we’ve ex­pand­ed it makes sense.

“Can­cer pa­tients don’t have bound­aries or bor­ders,” he added.

On top of all that, Seagen pre­sent­ed pos­i­tive Phase II da­ta at ES­MO just a few weeks ago. The com­pa­ny’s ex­per­i­men­tal drug ti­so­tum­ab ve­dotin, an an­ti­body-drug con­ju­gate cre­at­ed on its flag­ship tech, showed an av­er­age re­sponse last­ing 8.3 months and an ob­jec­tive re­sponse rate of 24% in 101 pa­tients with re­cur­rent or metasta­t­ic cer­vi­cal can­cer.

Though it was a sin­gle-arm tri­al, Seagen com­pared the re­sults to da­ta sug­gest­ing ex­ist­ing ther­a­pies “typ­i­cal­ly” have a re­sponse rate of less than 15% and pa­tients sur­vive for 6 to 9.4 months.

So why change things up now? Sie­gall said that the com­pa­ny had al­ready been call­ing it­self Seagen in­ter­nal­ly and in­ter­na­tion­al­ly, point­ing to its “seagen.com” email ad­dress­es in use since in­cep­tion and over­seas af­fil­i­ates such as Seagen France. By short­en­ing the name, Sie­gall said, Seagen not on­ly makes things less cum­ber­some but al­so lets the com­pa­ny stay at­tached to its Seat­tle roots.

“We def­i­nite­ly are proud of our Pa­cif­ic North­west roots; Seat­tle is known as the Emer­ald City and that’s why green is in our lo­go,” Sie­gall said. “While we are re­tain­ing our strong roots and the ‘S-E-A’ in our name, this ex­pan­sion re­al­ly makes it, we feel, a more ap­pro­pri­ate name for a glob­al com­pa­ny.”

Sie­gall likened it some­what to the de­liv­ery ser­vice Fed­er­al Ex­press shrink­ing its name to FedEx in the mid-1990s. Though the two com­pa­nies “have no sem­blance of com­par­i­son,” Sie­gall said, Seagen is adopt­ing a nick­name that’s been the un­of­fi­cial moniker for years and keep­ing the same col­ors in its lo­go.

At the end of the day, though, this re­brand­ing won’t change any­thing about Seagen’s busi­ness. Sie­gall talked at length about how the new name sig­ni­fies Seagen is an in­ter­na­tion­al com­pa­ny, but em­pha­sized that its can­cer prod­ucts re­main its true brand.

“This is not some­thing where we are try­ing to over­state our name change as some­thing more than what it is,” Sie­gall said. “This is a mi­nor change, but some­thing that we think is good go­ing for­ward and very pro­duc­tive. I don’t think any­one should view this as ‘Seat­tle Ge­net­ics is do­ing some­thing dif­fer­ent.’”

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $1 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Roche finds a home for a new, $500M man­u­fac­tur­ing lo­gis­tics hub, promis­ing 500 jobs

Roche is pouring $500 million into its Canadian headquarters in Mississauga, Ontario to set up a new hub that will coordinate logistics for its global supply chain.

Over the 5-year investment, the Swiss pharma giant expects to add 200 jobs over next year and another 300 by the end of 2023.

Introduced as a $190 million global pharmaceutical development site in 2011, the campus currently houses Roche’s Canadian commercial unit as well as product development, global procurement and pharma informatics. The new expansion will see it organize manufacturing across 13 plants and 11 sites, according to FiercePharma.

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CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

Covid-19 roundup: Ab­bott prof­its soar on test­ing kits; As­traZeneca could soon re­sume US vac­cine tri­als

Abbott Laboratories, one of the companies at the forefront of Covid-19 testing, is seeing big windfalls as a result of the pandemic.

The company reported its third-quarter results Wednesday morning, noting that overall profit went up 26.9% over the same period in 2019 as well as 28.2% in the first nine months of 2020 compared to that timeframe last year. Abbott’s Covid-19 tests drove the profits after seeing strong demand and helped the company beat quarterly estimates.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.