Covid-19 roundup: Catal­ent lends vac­cine pro­duc­tion ca­pac­i­ty to As­traZeneca/Ox­ford for hun­dreds of mil­lions dos­es

Catal­ent’s growth play in Italy a year ago is pay­ing off amid a dra­mat­ic ex­plo­sion in de­mand for space to pro­duce Covid-19 vac­cines. In a new deal with As­traZeneca, the Anag­ni site is charged with fill­ing the vials and pack­ag­ing Ox­ford’s ade­n­ovirus vec­tor-based can­di­date, now named AZD1222.

The sup­ply could reach hun­dreds of mil­lions of dos­es with round-the-clock man­u­fac­tur­ing sched­ules, be­gin­ning as ear­ly as this Au­gust should reg­u­la­tors stamp their OK and through to March 2022.

When Catal­ent ac­quired the site — com­plete with some 700 staffers — from Bris­tol My­ers Squibb last June, CEO John Chimin­s­ki em­pha­sized its rep­u­ta­tion as a launch­pad for new med­i­cines in Eu­rope.

“Catal­ent has sig­nif­i­cant ex­pe­ri­ence in the tech trans­fer and rapid scale-up of vac­cine pro­grams to meet de­mand,” Alessan­dro Masel­li, pres­i­dent and COO, added in a state­ment to­day.

The con­tract de­vel­op­ment and man­u­fac­tur­ing or­ga­ni­za­tion is al­so a part­ner to J&J and Arc­turus, help­ing the for­mer man­u­fac­ture an ade­n­ovirus vec­tor-based vac­cine while boost­ing the lat­ter’s low-pro­file mR­NA ap­proach.

Ger­many grabs mi­nor­i­ty stake in Cure­Vac with €300M in­vest­ment, tight­en­ing hold on mR­NA vac­cine

Just ahead of first-in-hu­man test­ing of Cure­Vac’s vac­cine can­di­date against Covid-19, Ger­man of­fi­cials said they are in­ject­ing €300 mil­lion of fed­er­al mon­ey in­to the com­pa­ny and its mR­NA plat­form tech­nol­o­gy. In re­turn they are earn­ing a seat at the ta­ble as a 23% stake­hold­er.

The Ger­man biotech was briefly the sub­ject of an in­ter­na­tion­al tus­sle when word got out that the Trump ad­min­is­tra­tion was try­ing to lure it to the US (pre­sum­ably so that Amer­i­cans would have bet­ter ac­cess to its Covid-19 vac­cine in de­vel­op­ment). Back­lash from its na­tive coun­try swift­ly fol­lowed, and in May Ger­many adopt­ed new rules to pro­tect health­care com­pa­nies from hos­tile takeovers by non-EU com­pa­nies.

Kred­i­tanstalt für Wieder­auf­bau, a state-owned de­vel­op­ment bank, is pro­vid­ing the $337 mil­lion to com­plete the trans­ac­tion.

“The Ger­man Fed­er­al gov­ern­ment has de­cid­ed to in­vest in this promis­ing com­pa­ny be­cause it ex­pects that this will ac­cel­er­ate the de­vel­op­ment pro­grams and pro­vide the means for Cure­Vac to har­ness the full po­ten­tial of its tech­nol­o­gy,” Pe­ter Alt­maier, min­is­ter for eco­nom­ic af­fairs and en­er­gy, said in a state­ment. “This is al­so of high im­por­tance for in­dus­tri­al pol­i­cy as we in Ger­many and Eu­rope need these es­sen­tial re­search re­sults and tech­nolo­gies.”

Ger­many has al­so teamed up with France, Italy and the Nether­lands to form the In­clu­sive Vac­cine Al­liance and se­cure a com­mit­ment of 400 mil­lion dos­es from As­traZeneca and Ox­ford.

For Cure­Vac, the fi­nan­cial com­mit­ment of­fers fur­ther cash reach and sta­bil­i­ty so that they can de­vel­op both the Covid-19 vac­cine and oth­er mR­NA drug can­di­dates more quick­ly. Pro­duc­tion can al­so be ramped up — an im­por­tant con­cern should clin­i­cal re­sults come back pos­i­tive.

The com­pa­ny has laid low af­ter a tur­bu­lent March, dur­ing which then-CEO Dan Manichel­la rep­re­sent­ed Cure­Vac at the White House meet­ing with bio­phar­ma ex­ec­u­tives. Founder In­g­mar Ho­err took over the reins soon af­ter that, on­ly to take a med­ical leave of ab­sence a few days lat­er. Un­like BioN­Tech, a biotech neigh­bor in Tübin­gen that’s al­so de­vel­op­ing a mR­NA vac­cine in part­ner­ship with Pfiz­er, Cure­Vac was not named a fi­nal­ist in Op­er­a­tion Warp Speed.

With vac­cines now con­sid­ered the bedrock of any hope to ful­ly re­open economies safe­ly, along­side test­ing and trac­ing ca­pa­bil­i­ties, se­cur­ing ac­cess to promi­nent can­di­dates now ap­pears vi­tal to the le­git­i­ma­cy of gov­ern­ments around the world.

As­traZeneca strikes sup­ply deal with Eu­rope, com­mit­ting an­oth­er 400 mil­lion out of 2B dos­es of vac­cines

An­oth­er 400 mil­lion dos­es of Ox­ford Uni­ver­si­ty’s vac­cine has been re­served.

Fol­low­ing sim­i­lar com­mit­ments with the US and UK, As­traZeneca has reached a deal with a new Eu­ro­pean ini­tia­tive spear­head­ed by Ger­many, France, Italy and the Nether­lands dubbed In­clu­sive Vac­cines Al­liance. The first de­liv­er­ies will be due by the end of 2020 — should the Phase II/III re­sults be pos­i­tive.

The IVA will pay €750 mil­lion ($843.1 mil­lion) for the first 300 mil­lion dos­es, Reuters re­port­ed cit­ing a spokesper­son for Italy’s health min­istry, which is pay­ing about €150 mil­lion for 75 mil­lion dos­es. The deal in­cludes an op­tion to buy a fur­ther 100 mil­lion dos­es.

“Eq­ui­table ac­cess” con­tin­ues to be a main theme, as the IVA promis­es to make vac­cines avail­able to all par­tic­i­pat­ing coun­tries across Eu­rope.

As As­traZeneca con­tin­ues to build sup­ply chains around the world to man­u­fac­ture and dis­trib­ute the ade­n­ovirus-based vac­cine can­di­date out of Ox­ford’s Jen­ner In­sti­tute, it said it’s se­cured ca­pac­i­ty for 2 bil­lion dos­es.

The US, which chipped in $1.2 bil­lion for the de­vel­op­ment and pro­duc­tion through BAR­DA, signed up for 300 mil­lion vials; an­oth­er 100 mil­lion is ear­marked for the UK.

For low- and mid­dle-in­come coun­tries, the Coali­tion for Epi­dem­ic Pre­pared­ness In­no­va­tions and Gavi, the Vac­cine Al­liance notched the rights to 300 mil­lion dos­es through a $750 mil­lion pact. At the same time, As­traZeneca grant­ed a li­cense to the Serum In­sti­tute of In­dia to sup­ply 1 bil­lion dos­es pri­mar­i­ly for poor­er pop­u­la­tions.

“This agree­ment will en­sure that hun­dreds of mil­lions of Eu­ro­peans have ac­cess to Ox­ford Uni­ver­si­ty’s vac­cine fol­low­ing ap­proval,” CEO Pas­cal So­ri­ot said in a state­ment. “With our Eu­ro­pean sup­ply chain due to be­gin pro­duc­tion soon, we hope to make the vac­cine avail­able wide­ly and rapid­ly.”

As­traZeneca has tak­en on the re­spon­si­bil­i­ty of ramp­ing up sup­plies, ne­go­ti­at­ing with coun­tries about dis­tri­b­u­tion as well as re­cruit­ing vol­un­teers and pro­vid­ing sup­port to the clin­i­cal pro­gram since com­ing on board as a part­ner in April. While it’s un­clear whether or how much own­er­ship the com­pa­ny has in the vac­cine — whose name was changed from ChA­dOx1 nCoV-19 to AZD1222 in the process — it’s promised to sup­ply the im­mu­niza­tion at no prof­it dur­ing the pan­dem­ic.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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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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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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CAR-plus: Irish biotech re­cruits Kite alum Chris Now­ers to prep dual-tar­get­ing NK cell ther­a­py for the clin­ic

Soon after Chris Nowers left Cell Medica — freshly rebranded Kuur Therapeutics — in February, the Kite Pharma alum was introduced to another cell therapy player.

The basic idea of building an off-the-shelf allogeneic platform with a CAR-NK approach was familiar to him, riding on the same wave as Takeda, J&J-backed Fate, Nkarta and others. But then there was something else that stood out: a membrane-bound TNF related apoptosis inducing ligand variant, or TRAIL variant, that’s also engineered onto the NK cell for a dual-targeted attack.

News brief­ing: Ab­b­Vie and Roche's Ven­clex­ta scores an­oth­er FDA OK; Im­muno­Gen nabs Chi­na deal with $40M cash

AbbVie and Roche’s Venclexta has gotten a new FDA thumbs up.

The pair announced Monday that regulators have approved the drug in combination with azacitidine or low-dose cytarabine for newly-diagnosed acute myeloid leukemia in adults who are 75 or older or those who can’t undergo intensive chemotherapy. This follows the drug’s accelerated approval in 2018 and positive data from two Phase III confirmatory trials.

James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

Joe Biden (Carolyn Kaster, AP Images)

What about the Ger­man ne­go­ti­a­tion mod­el? Biden steers drug pric­ing de­bate to a show­down

From an ill-fated proposal to ban rebates for pharmacy benefit managers to an executive order demanding a “most-favored-nation price” for Medicare, if nothing else President Donald Trump has introduced Americans to a flurry of ideas to rein in pharma, an industry he once accused of “getting away with murder.” And now we’re getting the first glimpse of what a Joe Biden presidency might mean for prescription drug pricing.