Ab­b­Vie hatch­es plans for a ma­jor new R&D hub close to its part­ners in Bay Area's buzzy Oys­ter Point

Ab­b­Vie has signed on to be the first ten­ant of a mas­sive new re­search cen­ter in Oys­ter Point, join­ing a flock of bio­phar­ma peers that’s set up shop in the in­creas­ing­ly pop­u­lar South San Fran­cis­co neigh­bor­hood.

The North Chica­go, IL-based drug­mak­er — whose Stem­cen­tryx sub­sidiary has an op­er­a­tion in the area — is leas­ing al­most 480,000 square feet in the Gate­way of Pa­cif­ic, a 1.4 mil­lion square foot cam­pus un­der con­struc­tion by Bio­Med Re­al­ty. Ink­ing a deal for 10 years, Ab­b­Vie will oc­cu­py a 12-sto­ry tow­er in a space that could even­tu­al­ly hold 1,500 work­ers, the San Fran­cis­co Busi­ness Times re­port­ed.

The new fa­cil­i­ty will “rep­re­sent a Bay Area hub for Ab­b­Vie’s on­col­o­gy busi­ness,” which is cur­rent­ly spread be­tween three dis­tinct lo­ca­tions in the re­gion, Ab­b­Vie spokesper­son Ilke Limon­cu tells End­points News.

“This fu­ture fa­cil­i­ty will al­so fur­ther strength­en our pres­ence in the Bay Area and bring to­geth­er our cur­rent three sites to im­prove col­lab­o­ra­tion and help us grow Ab­b­Vie’s on­col­o­gy sci­ence, re­search, in­no­va­tion and pa­tient care am­bi­tions,” he writes in an email.

The new lo­ca­tion would make Ab­b­Vie a neigh­bor of Genen­tech’s Gate­way cam­pus, while plac­ing it just 10 min­utes away from mul­ti­ple part­ners at Cal­i­co, Cy­tomX and Alec­tor.

When Ab­b­Vie and Cal­i­co re­newed their mon­ster dis­cov­ery deal in June, each com­mit­ting $500 mil­lion more to their al­liance, the Google-backed an­ti-ag­ing biotech made the un­usu­al move to an­nounce that it’s built a team of 150-plus around an HQ base in South San Fran­cis­co, with plans to add more.

Big names and fledg­ling biotechs alike have tak­en a lik­ing to the R&D hub in San Fran­cis­co, with Oys­ter Point in par­tic­u­lar buzzing with new oc­cu­pants. Sang­amo un­veiled plans to build a new HQ right on a ma­ri­na late last year, while As­traZeneca is bring­ing staffers from var­i­ous biotechs it ac­quired to­geth­er at its Cove at Oys­ter Point site.

“The core of Ab­b­Vie’s ini­tia­tive is fo­cused on the tal­ent, in­no­va­tion and cul­ture in the Bay Area,” Di­no Per­az­zo, a rep­re­sen­ta­tive of Ab­b­vie from re­al es­tate bro­ker­age CBRE’s life sci­ence prac­tice, told the San Fran­cis­co Busi­ness Times. “Theirs is the first of what will like­ly be many phar­ma ini­tia­tives com­ing to the Bay Area in the near fu­ture.”

While the the first phase of Gate­way of Pa­cif­ic is ex­pect­ed to com­plete in 2019 — with 431,000 square feet in phase II space to come lat­er — Ab­b­Vie won’t be­gin to move in un­til 2021, when its cur­rent Cal­i­for­nia leas­es ex­pire, Limon­cu con­firms.


Im­age: GATE­WAY OF PA­CIF­IC

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: 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.

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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UP­DAT­ED: 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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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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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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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Years af­ter a ma­jor tri­al set­back, No­var­tis switch­es gears with SMA drug. This time they're try­ing it for Hunt­ing­ton's

Four years after a Phase I/II setback in spinal muscular atrophy (SMA), Novartis is hoping its drug branaplam will find more success in a new neurological indication: Huntington’s disease.

The decision was announced a year after the head of research, Jay Bradner, said he did not see a “big opportunity” in SMA, according to Reuters. Novartis says it has preclinical data showing that branaplam reduces levels of mutant huntingtin protein, and SMA data showing patients on the drug had reductions in huntingtin mRNA. The FDA gave branaplam their orphan drug designation, and Novartis plans to move forth with a Phase IIb trial next year.

Glax­o­SmithK­line's vac­cines group aims for a first as it kicks off PhI­II RSV stud­ies

One of GlaxoSmithKline’s big projects at its global vaccine R&D center in Rockville, MD is set to enter Phase III after passing early-stage tests with flying colors.

Eyeing the wide-open respiratory syncytial virus (RSV) space, GSK is pushing two different vaccine candidates: GSK3888550A is designed to confer protection to infants via maternal immunization, while GSK3844766A is meant for the elderly.