Am­gen puts its foot down in shiny new South San Fran­cis­co hub as it re­or­ga­nizes R&D ops

Am­gen has signed up to be Ab­b­Vie’s neigh­bor in South San Fran­cis­co as it moves in­to a nine-sto­ry R&D fa­cil­i­ty in the boom­ing biotech hub.

The arrange­ment gives Am­gen 240,000 square feet of space on the Gate­way of Pa­cif­ic Cam­pus, just a few min­utes dri­ve from its cur­rent digs at Oys­ter Point. The new hub will open in 2022 and house the big biotech’s Bay Area em­ploy­ees work­ing on car­diometa­bol­ic, in­flam­ma­tion and on­col­o­gy re­search.

Flav­ius Mar­tin

Since an­nounc­ing its de­ci­sion to pull out of neu­ro­sciences Am­gen has been con­sol­i­dat­ing US-based re­search to South San Fran­cis­co and Thou­sand Oaks, where it’s head­quar­tered. But in ad­di­tion to the 149 jobs they were ax­ing in Cam­bridge — where the neu­ro­science team was large­ly based — Am­gen is al­so lay­ing off 172 staffers na­tion­wide in an ef­fort to cut op­er­a­tions, R&D and field-based com­mer­cial po­si­tions.

Flav­ius Mar­tin, Am­gen’s South San Fran­cis­co site-head, said the lo­ca­tion has been home to “in­te­grat­ing hu­man ge­net­ics with core bi­ol­o­gy and mol­e­c­u­lar en­gi­neer­ing to dis­cov­er and de­vel­op first-in-class ther­a­pies.”

“The new lo­ca­tion will fos­ter even greater col­lab­o­ra­tion across our strong sci­en­tif­ic team, ac­cel­er­ate the R&D process, and pro­vide a venue for in­creased en­gage­ment with the Bay Area’s abun­dant sci­en­tif­ic and ed­u­ca­tion­al com­mu­ni­ties,” said Mar­tin, who al­so leads re­search in on­col­o­gy and in­flam­ma­tion, in a state­ment.

Af­ter Am­gen un­veiled the news, its land­lord Health­peak fol­lowed up lat­er to re­port that they are re­vis­ing the terms of their ex­ist­ing leas­es at Oys­ter Point, ex­tend­ing the deal (which was due to ex­pire in two years) to the end of 2029. At the same time, Am­gen has al­so ne­go­ti­at­ed for a right to ter­mi­nate their leas­es ear­ly.

Ab­b­Vie was the first big name drug­mak­er to re­serve space at the Gate­way of Pa­cif­ic, claim­ing 480,000 square feet for 10 years to build a cen­tral spot for its on­col­o­gy busi­ness close to sev­er­al of its neigh­bors, in­clud­ing Cal­i­co, Cy­tomX and Alec­tor.

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. Genen­tech has re­cent­ly sub­mit­ted a plan to dra­mat­i­cal­ly ex­pand its sto­ried cam­pus.

Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for Covid-19 vac­cine -- shares rock­et up

CureVac is going from being one of the quietest players in the race to develop a new vaccine to fight the worst public health crisis in a century to a challenger for the multibillion-dollar market that awaits the first vaccines to make it over the finish line. Typically low-key at a time of brash comments and incredibly ambitious development timelines from the leaders, CureVac now is jumping straight into the spotlight.

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US gov­ern­ment re­port­ed­ly be­gins prepar­ing for Covid-19 chal­lenge tri­als. Are they eth­i­cal?

Controversial human challenge trials for potential Covid-19 vaccines reportedly have a new booster — the US government.

Scientists working for the government have begun manufacturing a strain of the novel coronavirus that could be used in such studies, Reuters reported Friday morning. The trials would enroll healthy volunteers to be vaccinated and then intentionally infected with a weakened coronavirus.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Trevor Martin (Mammoth)

Eye­ing in-vi­vo edit­ing, Mam­moth li­cens­es Jen­nifer Doud­na’s new CRISPR en­zyme

Last month, Jennifer Doudna revealed in Science a new, “hyper-compact” CRISPR enzyme that was half the size of traditional CRISPR enzymes and could, she suspected, offer a new, more versatile tool for gene editing.

Now, the University of California-Berkeley has licensed that enzyme, known as Casφ, exclusively to a biotech startup she and two former students set up three years ago: Mammoth Biosciences. It’s the second new CRISPR protein Mammoth has licensed from Doudna’s lab, after they licensed Cas14 in 2019.

Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics; As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes

PIC Therapeutics hasn’t raised much money, yet. But the fledgling biotech has attracted a high-profile player to the helm.

The Boston-based biotech has handed the reins to Katherine Bowdish as its president and CEO. Bowdish will also join the board of directors of PIC. Bowdish joins from Sanofi where she served as VP and head of R&D strategy, as well as helping launch and lead Sanofi Sunrise, a venture investment and partnering vehicle at Sanofi. Before that, Bowdish held several exec roles at Permeon Biologics, Anaphore, Alexion Pharmaceuticals and Prolifaron (acquired by Alexion).