Hack­ers steal Pfiz­er, BioN­Tech da­ta in EMA breach as cy­ber­se­cu­ri­ty at­tacks heat up

It’s been a good week for Covid-19 vac­cines, and per­haps an even bet­ter one for the hack­ers try­ing to steal Covid-19 vac­cine da­ta.

In a brief note Wednes­day, the Eu­ro­pean Med­i­cines Agency an­nounced that it had been “the sub­ject of a cy­ber-at­tack.” Pfiz­er and their Ger­man biotech part­ner BioN­Tech con­firmed their da­ta had been “un­law­ful­ly ac­cessed’ as part of the breach, al­though they cau­tioned to Reuters that they did not be­lieve par­tic­i­pants’ per­son­al in­for­ma­tion had been changed and that the EMA had as­sured them the hack would not in­ter­fere with the time­line for ap­proval.

Stolen doc­u­ments could po­ten­tial­ly give use­ful in­for­ma­tion to oth­er coun­tries de­vel­op­ing a vac­cine, as well as in­for­ma­tion on oth­er com­pa­nies and sys­tems in­volved in de­vel­op­ing and dis­trib­ut­ing it.

The lat­est in­ci­dent adds to a string of vac­cine-di­rect­ed cy­ber­se­cu­ri­ty at­tacks that have re­port­ed­ly struck through­out the pan­dem­ic. News re­ports of such ef­forts have picked up in re­cent weeks.

In May, as vac­cine ef­forts were ac­cel­er­at­ing, US of­fi­cials warned Chi­nese hack­ers were tar­get­ing vac­cine re­search, prompt­ing a swift de­nial from the Chi­nese gov­ern­ment.

In Ju­ly, though, Britain’s Na­tion­al Cy­ber Se­cu­ri­ty Cen­tre re­leased a re­port ac­cus­ing Russ­ian-backed groups, in­clud­ing one known as “Cozy Bear,” of tar­get­ing phar­ma­ceu­ti­cal com­pa­nies work­ing on vac­cines. The Cen­tre said that US and Cana­di­an of­fi­cials shared their as­sess­ment, and The Tele­graph re­port­ed that the As­traZeneca-Ox­ford ef­fort had been at­tacked. Rus­sia de­nied in­volve­ment.

Then last month, Mi­crosoft said that a Russ­ian group named “Fan­cy Bear” and two North Ko­re­an groups named “Zinc” and “Ceri­um” at­tempt­ed to break in­to sys­tems at 7 phar­mas and re­searchers in 5 coun­tries. That in­clud­ed brute force ef­forts to at­tempt mil­lions of po­ten­tial pass­words and phish­ing schemes where hack­ers would pose as World Health Or­ga­ni­za­tion of­fi­cials and so­lic­it peo­ple’s pass­words.

Last week, IBM said that hack­ers backed by for­eign gov­ern­ments had turned their at­ten­tion to the com­pa­nies that main­tain the cold chain nec­es­sary to ship and store mR­NA vac­cines. Among oth­er ef­forts, ad­ver­saries posed as an ex­ec­u­tive from the ma­jor cold chain com­pa­ny Haier Med­ical and so­licit­ed user­names and pass­words. The at­tacks were glob­al, IBM said.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Phil Sharp, Nobel Prize laureate (L), and John Carroll, Endpoints News co-CEO (via Michael Last)

The End­points 11: Fire­side chat with No­bel Prize lau­re­ate Phil Sharp

The following Q&A has been edited for length and clarity.

John Carroll:

We’ve had a chance to talk a little bit before here about some of the things that you’ve done. Just really remarkably, a lot of the things that you’ve done early in your career puts you in the path with some amazing science that has had an absolutely huge impact in terms of what we’re seeing now on drug development and some of the new technologies that are coming out here, and not only the new technologies, but also some of the most remarkable people ever.

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Petro Terblanche, Afrigen Biologics managing director (Kristin Palitza/picture-alliance/dpa/AP Images)

WHO-backed Afrigen plans a charge to­ward the clin­ic with Africa's first Covid-19 vac­cine

NEW YORK — When vaccines from high-income countries did not arrive in Africa, a local WHO-backed company decided to take the matter into its own hands.

The South Africa-based company Afrigen Biologics and Vaccines has developed the continent’s first mRNA Covid-19 vaccine that will enter clinical trials in early 2023. Afrigen developed the shot by copying publicly available sequencing information about Moderna’s shot after the biotech and Pfizer refused assistance.

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