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.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Douglas Love, Annexon CEO (Annexon)

IPO bound? A Bay Area biotech grabs a mega-round on the road to a piv­otal neu­rode­gen­er­a­tion pro­gram

South San Francisco-based Annexon has added $100 million to its cash reserves, along with a new roster of marquee investors backing their play on the classical complement pathway involved in neurodegeneration. And that may well fit the profile for an IPO — though right now everything seems to be working on that score.

Eighteen months after Bain and their syndicate partners put up $75 million to fuel clinical work, Annexon is back at the trough. And this time they’re adding Redmile Group for the lead role, with supporting investments from these new arrivals: BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Josh Cohen, Justin Klee

Armed with pos­i­tive ALS da­ta, Amy­lyx scores $30M in fresh fund­ing to com­plete Alzheimer's PhII

Four years after announcing themselves to the biotech world with a new idea for drugging neurodegeneration, backing by the late Henri Termeer and $5 million from Morningside Venture, the young entrepreneurs at Amylyx are back for round 2.

Morningside continued to lead the $30 million Series B, with participation from Termeer’s widow, Belinda, and other unnamed investors. Having celebrated a topline Phase II win for its lead program in amyotrophic lateral sclerosis, Amylyx expects the cash to fund talks with regulators as well as a separate trial for the same drug in Alzheimer’s — for which they had just finished enrolling.