Take­da opens cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty — tucked right in its Boston R&D hub

When Take­da un­veiled its trans­la­tion­al cell ther­a­py en­gine ear­ly last year, the Japan­ese phar­ma made it clear the crew, un­der No­var­tis vet Ste­fan Wildt, is go­ing all the way: clin­i­cal ex­per­tise, bio­engi­neer­ing chops, world-class col­lab­o­ra­tions, plus chem­istry, man­u­fac­tur­ing and con­trol.

The fi­nal piece of the puz­zle has now fall­en in place, with the open­ing of a 24,000 square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its R&D head­quar­ters in Boston.

“In that ear­ly space, hav­ing it sit­u­at­ed in prox­im­i­ty to our teams is quite pow­er­ful,” Chris Arendt, head of the on­col­o­gy ther­a­peu­tic area unit, told End­points News. “When you think about it, the process de­fines very much the med­i­cine and the cell ther­a­py space”

De­signed to pro­duce clin­i­cal-grade ma­te­r­i­al from dis­cov­ery through piv­otal Phase IIb tri­als, the site will sup­port five on­go­ing pacts. They in­clude pluripo­tent stem cell work with Ky­oto Uni­ver­si­ty No­bel lau­re­ate Shinya Ya­mana­ka, gam­ma delta T cell re­search with Adri­an Hay­day and his biotech, ar­mored CAR-Ts with Ko­ji Tama­da at Noile-Im­mune Biotech, next-gen CARs with Memo­r­i­al Sloan Ket­ter­ing’s Michel Sade­lain, and fi­nal­ly CAR-NK with Katy Rez­vani at MD An­der­son.

Chris Arendt

With three pro­grams now in the clin­ic, Take­da is now pick­ing two more to test in hu­mans in 2021, Arendt said. While each re­search part­ner­ship has tak­en on its own be­spoke ap­proach to man­u­fac­tur­ing up to now, the new fa­cil­i­ty will pro­vide a cen­tral spot to lock down the process de­vel­op­ment as close to the fi­nal prod­uct as pos­si­ble.

At the fore­front are TAK-007, an al­lo­gene­ic CD19-tar­get­ed CAR-NK be­ing test­ed in Phase I/II for re­lapsed or re­frac­to­ry non-Hodgkin’s lym­phoma; TAK-940, 19(T2)28z1xx CAR-T cells fea­tur­ing a next-gen sig­nal­ing do­main from MSK; and TAK-102, a cy­tokine and chemokine ar­mored CAR-T di­rect­ed at GPC3-ex­press­ing pre­vi­ous­ly treat­ed sol­id tu­mors. The lat­ter two are in first-in-hu­man tri­als.

Hav­ing a ded­i­cat­ed fa­cil­i­ty scales the op­er­a­tions up so that the team can si­mul­ta­ne­ous­ly ad­vance mul­ti­ple pro­grams, he added.

Be­fore the Covid-19 pan­dem­ic sucked out all the oxy­gen in the room, the boom­ing cell ther­a­py mar­ket’s de­mand for phys­i­cal in­fra­struc­ture cap­tured con­sid­er­able at­ten­tion. Gilead’s Kite con­struct­ed its own vi­ral vec­tor man­u­fac­tur­ing cen­ter in or­der to leave “no stone un­turned. Con­tract man­u­fac­tur­ers like Catal­ent were snap­ping up space, and even Deer­field got in­to the game with a splashy, $1.1 bil­lion en­trance.

Ste­fan Wildt

The way he’s built the team — now grown to well over 150 sci­en­tists — the learn­ings from any one pro­gram can be quick­ly ap­plied to the whole port­fo­lio, Wildt not­ed.

“We want­ed to place the en­gine team at that sweet spot be­tween late-stage dis­cov­ery and rapid­ly putting for­ward in­no­v­a­tive ideas and con­cepts in­to clin­i­cal trans­la­tion,” he said. “It was just a con­cept a few years ago. And now we can part­ner with hos­pi­tals and pa­tients and re­al­ly see hope­ful­ly we can be suc­cess­ful on their be­half.”

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

Anthony Fauci (AP Images)

A press of­fi­cer at An­tho­ny Fau­ci’s NI­AID was un­masked as a hard-right Covid troll. He just re­tired to­day

William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases.

That ended today when he informed the agency of his decision to retire, after he was identified as the managing editor at RedState, a prominent Trump loyalist website.

Crews’ RedState duties are performed under the alias streiff. While enjoying the benefits of pseudonymity, he disparaged and worked against NIAID with an incendiary level of rhetoric in the midst of a pandemic.

#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Frank Zhang (AP Images)

Rocked by cus­toms in­ves­ti­ga­tion, Leg­end's CFO takes over as CEO Frank Zhang placed un­der house ar­rest

When Frank Zhang stepped down from GenScript — the contract research group he’s run for 18 years — to take up the CEO post at its CAR-T focused spinout Legend Biotech, he assured analysts that he was in for the long haul.

Just 49 days later, though, he’s been forced to hand back the title.

In a dramatic turn of events, Legend disclosed that Zhang is under house arrest in China as part of a customs investigation involving GenScript. While he remains the chairman, CFO Ying Huang has been tapped to double as interim CEO.

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UP­DAT­ED: Two wild weeks for Grail end in $8B Il­lu­mi­na buy­out

Grail’s whirlwind two weeks have ended in the wealthy arms of its former founder and benefactors.

Illumina has shelled out $8 billion to reacquire the closely-watched liquid biopsy startup they spun out just 5 years ago and sold off much of its shares just 3 years ago. The deal comes nearly two weeks after the well-heeled startup filed for a potentially massive IPO — one that was disrupted just a week later when Bloomberg reported that Illumina was in talks to buy their former spinout for up to $8 billion.

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Roche vaults to the front of the NL­RP3 clin­i­cal race, pay­ing $448M up­front to bag In­fla­zome

Roche is going all in on NLRP3.

The pharma giant is putting down $448 million (€380 million) upfront to snatch Novartis-backed Inflazome, which makes it a clinical player in the space overnight.

Dublin and Cambridge, UK-based Inflazome is the second NLRP3-focused biotech Roche has acquired in less than two years, and although no numbers were disclosed in the Jecure buyout, this is almost certainly a much larger deal.

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#ES­MO20: Bris­tol My­ers marks Op­di­vo's sec­ond ad­ju­vant win — eye­ing a stan­dard of care gap

Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease.

With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm.

While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center. The recurrence rate is also high within the first year, Hirawat added.

Donald Trump, AP

Covid-19 roundup: Trump sug­gests Pfiz­er vac­cine could be first ap­proved; VBI Vac­cines inks de­vel­op­ment deal with Cana­da

President Donald Trump commented Monday morning that Pfizer’s Covid-19 vaccine candidate could be the first to win approval by regulators.

During an interview on a Fox News’ morning show, the president said Pfizer was doing “very well” when asked which candidate could be approved, according to a Reuters report. He added that J&J could follow up afterward, saying “they’ll probably be a little later.”

Is­raeli biotech rais­es $57M to go where cur­rent BRAF in­hibitors can't, with back­ing from No­var­tis, SR One

For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients.

Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else.

The Series C will fund a Phase II trial for PLX-8394, a “paradox breaker” that could block RAF without activating MAPK signaling. In a Phase I trial, a patient with a BRAF fusion saw their tumor go away after taking the drug, allowing Novellus to hit the ground running.