Brazil­ian vol­un­teer in As­traZeneca Covid-19 vac­cine tri­al has died in the place­bo arm — re­ports

A vol­un­teer in As­traZeneca’s Covid-19 vac­cine tri­al in Brazil has died, Brazil­ian health au­thor­i­ties said Wednes­day, trig­ger­ing fresh alarms over the fu­ture of the Ox­ford pro­gram. But lat­er re­ports not­ed that the death was in the place­bo group and As­traZeneca is­sued word that there were no con­cerns about con­tin­u­ing the study.

The Brazil­ian health agency An­visa said it had re­ceived da­ta from an in­ves­ti­ga­tion in­to the is­sue, per a Reuters re­port. The re­port was then up­dat­ed cit­ing a source fa­mil­iar with the mat­ter say­ing that the tri­al would have been sus­pend­ed had the vol­un­teer been giv­en the ex­per­i­men­tal Covid-19 vac­cine, im­ply­ing that they were part of the place­bo arm.

Ox­ford Uni­ver­si­ty, which is de­vel­op­ing the vac­cine in tan­dem with As­traZeneca, told Reuters that af­ter as­sess­ing the sit­u­a­tion, “there have been no con­cerns about safe­ty of the clin­i­cal tri­al.” An­visa added that the vac­cine tri­als will con­tin­ue in the wake of the death. The agency gave no fur­ther de­tails in­to the cir­cum­stances.

As­traZeneca $AZN share prices dipped about 2% as the news broke, but since lev­eled off and closed Wednes­day down 1.19%.

A com­pa­ny spokesper­son gave the fol­low­ing com­ment to End­points News:

We can­not com­ment on in­di­vid­ual cas­es in an on­go­ing tri­al of the Ox­ford vac­cine as we ad­here strict­ly to med­ical con­fi­den­tial­i­ty and clin­i­cal tri­al reg­u­la­tions, but we can con­firm that all re­quired re­view process­es have been fol­lowed. All sig­nif­i­cant med­ical events are care­ful­ly as­sessed by tri­al in­ves­ti­ga­tors, an in­de­pen­dent safe­ty mon­i­tor­ing com­mit­tee and the reg­u­la­to­ry au­thor­i­ties. These as­sess­ments have not led to any con­cerns about con­tin­u­a­tion of the on­go­ing study.

Re­ports ear­li­er Wednes­day not­ed that As­traZeneca was sched­uled to restart its Phase III study in the US some­time this week. Dos­ing came to a halt world­wide in ear­ly Sep­tem­ber af­ter a British vol­un­teer de­vel­oped a con­di­tion thought to be trans­verse myelitis, a rare spinal in­flam­ma­tion dis­or­der.

Tri­als have al­ready re­sumed in the UK, In­dia, Japan and South Africa in ad­di­tion to Brazil, and the EMA has since ini­ti­at­ed a rolling re­view of the vac­cine can­di­date.

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

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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Christian Itin, Autolus CEO (UKBIO19)

Au­to­lus tips its hand, bags $220M as CAR-T show­down with Gilead looms

The first batch of pivotal data on Autolus Therapeutics’ CAR-T is in, and execs are ready to plot a path to market.

With an overall remission rate of 70% at the interim analysis featuring 50 patients, the results set the stage for a BLA filing by the end of 2023, said CEO Christian Itin.

Perhaps more importantly — given that Autolus’ drug, obe-cel, is going after an indication that Gilead’s Tecartus is already approved for — the biotech highlighted “encouraging safety data” in the trial, with a low percentage of patients experiencing severe immune responses.